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| <pmc-articleset> | |
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| <front> | |
| <journal-meta> | |
| <journal-id journal-id-type="nlm-ta">Integr Cancer Ther</journal-id> | |
| <journal-id journal-id-type="iso-abbrev">Integr Cancer Ther</journal-id> | |
| <journal-id journal-id-type="publisher-id">ICT</journal-id> | |
| <journal-id journal-id-type="hwp">spict</journal-id> | |
| <journal-title-group> | |
| <journal-title>Integrative Cancer Therapies</journal-title> | |
| </journal-title-group> | |
| <issn pub-type="ppub">1534-7354</issn> | |
| <issn pub-type="epub">1552-695X</issn> | |
| <publisher> | |
| <publisher-name>SAGE Publications</publisher-name> | |
| <publisher-loc>Sage CA: Los Angeles, CA</publisher-loc> | |
| </publisher> | |
| </journal-meta> | |
| <article-meta> | |
| <article-id pub-id-type="pmid">38757745</article-id> | |
| <article-id pub-id-type="pmc">11102686</article-id> | |
| <article-id pub-id-type="doi">10.1177/15347354241252698</article-id> | |
| <article-id pub-id-type="publisher-id">10.1177_15347354241252698</article-id> | |
| <article-categories> | |
| <subj-group subj-group-type="heading"> | |
| <subject>Study Protocol</subject> | |
| </subj-group> | |
| </article-categories> | |
| <title-group> | |
| <article-title>Exploring Guolin Qigong (Mind-Body Exercise) for Improving Cancer Related | |
| Fatigue in Cancer Survivors: A Mixed Method Randomized Controlled Trial Protocol</article-title> | |
| </title-group> | |
| <contrib-group> | |
| <contrib contrib-type="author"> | |
| <contrib-id contrib-id-type="orcid" authenticated="false"> | |
| https://orcid.org/0000-0001-6296-6052</contrib-id> | |
| <name> | |
| <surname>Low</surname> | |
| <given-names>Sara L. K.</given-names> | |
| </name> | |
| <degrees>MRes</degrees> | |
| <xref rid="aff1-15347354241252698" ref-type="aff">1</xref> | |
| </contrib> | |
| <contrib contrib-type="author"> | |
| <name> | |
| <surname>Ho</surname> | |
| <given-names>Gwo Fuang</given-names> | |
| </name> | |
| <degrees>FRANZCR</degrees> | |
| <xref rid="aff2-15347354241252698" ref-type="aff">2</xref> | |
| </contrib> | |
| <contrib contrib-type="author"> | |
| <name> | |
| <surname>Liu</surname> | |
| <given-names>Bingkai</given-names> | |
| </name> | |
| <degrees>PhD</degrees> | |
| <xref rid="aff3-15347354241252698" ref-type="aff">3</xref> | |
| </contrib> | |
| <contrib contrib-type="author"> | |
| <name> | |
| <surname>Koh</surname> | |
| <given-names>Eng-Siew</given-names> | |
| </name> | |
| <degrees>FRANZCR</degrees> | |
| <xref rid="aff4-15347354241252698" ref-type="aff">4</xref> | |
| </contrib> | |
| <contrib contrib-type="author"> | |
| <name> | |
| <surname>Fei</surname> | |
| <given-names>Yutong</given-names> | |
| </name> | |
| <degrees>PhD</degrees> | |
| <xref rid="aff5-15347354241252698" ref-type="aff">5</xref> | |
| </contrib> | |
| <contrib contrib-type="author"> | |
| <contrib-id contrib-id-type="orcid" authenticated="false"> | |
| https://orcid.org/0000-0003-1071-443X</contrib-id> | |
| <name> | |
| <surname>Teo</surname> | |
| <given-names>Chiah Shean</given-names> | |
| </name> | |
| <degrees>MD</degrees> | |
| <xref rid="aff6-15347354241252698" ref-type="aff">6</xref> | |
| </contrib> | |
| <contrib contrib-type="author"> | |
| <contrib-id contrib-id-type="orcid" authenticated="false"> | |
| https://orcid.org/0000-0002-2909-5926</contrib-id> | |
| <name> | |
| <surname>Zhu</surname> | |
| <given-names>Xiaoshu</given-names> | |
| </name> | |
| <degrees>PhD</degrees> | |
| <xref rid="aff1-15347354241252698" ref-type="aff">1</xref> | |
| <xref rid="corresp1-15347354241252698" ref-type="corresp" /> | |
| </contrib> | |
| </contrib-group> | |
| <aff id="aff1-15347354241252698"><label>1</label>Western Sydney University, Penrith South, | |
| NSW, Australia</aff> | |
| <aff id="aff2-15347354241252698"><label>2</label>University Malaya Medical Centre, Kuala | |
| Lumpur, Wilayah Persekutuan, Malaysia</aff> | |
| <aff id="aff3-15347354241252698"><label>3</label>Pitié-Salpêtrière Hospital, | |
| Paris, France</aff> | |
| <aff id="aff4-15347354241252698"><label>4</label>University of New South Wales, Liverpool, | |
| NSW, Australia</aff> | |
| <aff id="aff5-15347354241252698"><label>5</label>Beijing University of Chinese Medicine, | |
| Beijing, China</aff> | |
| <aff id="aff6-15347354241252698"><label>6</label>UCSI University, Malaysia</aff> | |
| <author-notes> | |
| <corresp id="corresp1-15347354241252698">Xiaoshu Zhu, Chinese Medicine Centre (an | |
| international collaboration between Western Sydney University and Beijing University of | |
| Chinese Medicine), Western Sydney University, Locked Bag 1797, Penrith, NSW 2751, | |
| Australia. Email: <email>x.zhu@westernsydney.edu.au</email></corresp> | |
| </author-notes> | |
| <pub-date pub-type="epub"> | |
| <day>17</day> | |
| <month>5</month> | |
| <year>2024</year> | |
| </pub-date> | |
| <pub-date pub-type="collection"> | |
| <year>2024</year> | |
| </pub-date> | |
| <volume>23</volume> | |
| <elocation-id>15347354241252698</elocation-id> | |
| <history> | |
| <date date-type="received"> | |
| <day>5</day> | |
| <month>8</month> | |
| <year>2023</year> | |
| </date> | |
| <date date-type="rev-recd"> | |
| <day>5</day> | |
| <month>4</month> | |
| <year>2024</year> | |
| </date> | |
| <date date-type="accepted"> | |
| <day>18</day> | |
| <month>4</month> | |
| <year>2024</year> | |
| </date> | |
| </history> | |
| <permissions> | |
| <copyright-statement>© The Author(s) 2024</copyright-statement> | |
| <copyright-year>2024</copyright-year> | |
| <copyright-holder content-type="sage">SAGE Publications Inc unless otherwise noted. | |
| Manuscript content on this site is licensed under Creative Commons Licenses</copyright-holder> | |
| <license> | |
| <ali:license_ref xmlns:ali="http://www.niso.org/schemas/ali/1.0/" | |
| specific-use="textmining" content-type="ccbylicense"> | |
| https://creativecommons.org/licenses/by/4.0/</ali:license_ref> | |
| <license-p>This article is distributed under the terms of the Creative Commons | |
| Attribution 4.0 License (<ext-link ext-link-type="uri" | |
| xlink:href="https://creativecommons.org/licenses/by/4.0/"> | |
| https://creativecommons.org/licenses/by/4.0/</ext-link>) which permits any use, | |
| reproduction and distribution of the work without further permission provided the | |
| original work is attributed as specified on the SAGE and Open Access page (<ext-link | |
| ext-link-type="uri" | |
| xlink:href="https://us.sagepub.com/en-us/nam/open-access-at-sage"> | |
| https://us.sagepub.com/en-us/nam/open-access-at-sage</ext-link>).</license-p> | |
| </license> | |
| </permissions> | |
| <abstract> | |
| <sec id="section1-15347354241252698"> | |
| <title>Background:</title> | |
| <p>Cancer-related fatigue and its associated symptoms of sleep disorder and depression | |
| are prevalent in cancer survivors especially among breast, lung, and colorectal cancer | |
| survivors. While there is no gold standard for treating cancer-related fatigue | |
| currently, studies of mind-body exercises such as Qigong have reported promise in | |
| reducing symptoms. This study was designed to evaluate the feasibility and effect of | |
| Guolin Qigong on cancer-related fatigue and other symptoms in breast, lung and | |
| colorectal cancer survivors while exploring their perceptions and experiences of | |
| Guolin Qigong intervention.</p> | |
| </sec> | |
| <sec id="section2-15347354241252698"> | |
| <title>Methods:</title> | |
| <p>This is an open-label randomized controlled trial with 60 participants divided into 2 | |
| study groups in a 1:1 ratio. The intervention group will receive 12 weeks of | |
| Guolin Qigong intervention with a 4-week follow-up while control will receive usual | |
| care under waitlist. The primary outcome will be feasibility measured based on | |
| recruitment and retention rates, class attendance, home practice adherence, nature, | |
| and quantum of missing data as well as safety. The secondary subjective outcomes of | |
| fatigue, sleep quality and depression will be measured at Week-1 (baseline), Week-6 | |
| (mid-intervention), Week-12 (post-intervention), and Week-16 (4 weeks | |
| post-intervention) while an objective 24-hour urine cortisol will be measured at | |
| Week-1 (baseline) and Week-12 (post-intervention). We will conduct a semi-structured | |
| interview individually with participants within 3 months after Week-16 | |
| (4 weeks post-intervention) to obtain a more comprehensive view of practice | |
| adherence.</p> | |
| </sec> | |
| <sec id="section3-15347354241252698"> | |
| <title>Discussion:</title> | |
| <p>This is the first mixed-method study to investigate the feasibility and effect of | |
| Guolin Qigong on breast, lung, and colorectal cancer survivors to provide a | |
| comprehensive understanding of Guolin Qigong’s intervention impact and | |
| participants’ perspectives. The interdisciplinary collaboration between Western | |
| Medicine and Chinese Medicine expertise of this study ensures robust study design, | |
| enhanced participant care, rigorous data analysis, and meaningful interpretation of | |
| results. This innovative research contributes to the field of oncology and may guide | |
| future evidence-based mind-body interventions to improve cancer survivorship.</p> | |
| </sec> | |
| <sec id="section4-15347354241252698"> | |
| <title>Trial registration:</title> | |
| <p>This study has been registered with ANZCTR (ACTRN12622000688785p), was approved by | |
| Medical Research Ethic Committee of University Malaya Medical Centre (MREC ID NO: | |
| 2022323-11092) and recognized by Western Sydney University Human Research Ethics | |
| Committee (RH15124).</p> | |
| </sec> | |
| </abstract> | |
| <kwd-group> | |
| <kwd>Qigong</kwd> | |
| <kwd>cancer</kwd> | |
| <kwd>cancer survivors</kwd> | |
| <kwd>fatigue</kwd> | |
| <kwd>sleep</kwd> | |
| <kwd>insomnia</kwd> | |
| <kwd>depression</kwd> | |
| <kwd>cortisol</kwd> | |
| <kwd>mind body exercise</kwd> | |
| </kwd-group> | |
| <funding-group specific-use="FundRef"> | |
| <award-group id="award1-15347354241252698"> | |
| <funding-source id="funding1-15347354241252698"> | |
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| <institution>Chinese Medicine Centre</institution> | |
| <institution-id /> | |
| </institution-wrap> | |
| </funding-source> | |
| <award-id rid="funding1-15347354241252698">Research Fund</award-id> | |
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| <award-group id="award2-15347354241252698"> | |
| <funding-source id="funding2-15347354241252698"> | |
| <institution-wrap> | |
| <institution>Western Sydney University</institution> | |
| <institution-id institution-id-type="FundRef">https://doi.org/10.13039/501100018822</institution-id> | |
| </institution-wrap> | |
| </funding-source> | |
| <award-id rid="funding2-15347354241252698">Research Training Program Fund</award-id> | |
| </award-group> | |
| </funding-group> | |
| <custom-meta-group> | |
| <custom-meta> | |
| <meta-name>cover-date</meta-name> | |
| <meta-value>January-December 2024</meta-value> | |
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| </front> | |
| <body> | |
| <sec id="section5-15347354241252698"> | |
| <title>Background</title> | |
| <p>Cancer-related fatigue (CRF) has been increasingly recognized as an important symptom | |
| during and after treatment of cancer, impacting physical, mental, and emotional functions.<sup> | |
| <xref rid="bibr1-15347354241252698" ref-type="bibr">1</xref> | |
| </sup> CRF is a | |
| prevalent symptom among survivors of the most common types of cancer, including breast, | |
| lung, and colon cancer.<sup><xref rid="bibr2-15347354241252698" ref-type="bibr">2</xref>,<xref | |
| rid="bibr3-15347354241252698" ref-type="bibr">3</xref></sup> It is a distressing | |
| symptom<sup> | |
| <xref rid="bibr3-15347354241252698" ref-type="bibr">3</xref> | |
| </sup> and one of | |
| the main reasons for the interruption of treatment or exacerbation of the disease.<sup> | |
| <xref rid="bibr2-15347354241252698" ref-type="bibr">2</xref> | |
| </sup> Between 74% | |
| and 90% of cancer survivors undergoing chemotherapy or radiotherapy<sup><xref | |
| rid="bibr4-15347354241252698" ref-type="bibr">4</xref> | |
| <xref | |
| rid="bibr5-15347354241252698" ref-type="bibr" />-<xref rid="bibr6-15347354241252698" | |
| ref-type="bibr">6</xref></sup> experienced fatigue with adverse effect on other | |
| co-morbidity, quality of life, independent living, and work productivity.<sup><xref | |
| rid="bibr3-15347354241252698" ref-type="bibr">3</xref>,<xref | |
| rid="bibr7-15347354241252698" ref-type="bibr">7</xref></sup> While fatigue is more | |
| prevalent within 6 months of receiving cancer treatment, cancer survivors including | |
| those who did not receive treatment continue to experience fatigue many years after | |
| treatment.<sup> | |
| <xref rid="bibr5-15347354241252698" ref-type="bibr">5</xref> | |
| </sup></p> | |
| <p>Cancer diagnosis and its treatment also bring with it a host of physiological changes | |
| affecting various functions of the body including cortisol dysregulation associated with | |
| fatigue,<sup><xref rid="bibr8-15347354241252698" ref-type="bibr">8</xref> | |
| <xref | |
| rid="bibr9-15347354241252698" ref-type="bibr" /><xref rid="bibr10-15347354241252698" | |
| ref-type="bibr" /><xref rid="bibr11-15347354241252698" ref-type="bibr" />-<xref | |
| rid="bibr12-15347354241252698" ref-type="bibr">12</xref></sup> sleep disorders,<sup><xref | |
| rid="bibr8-15347354241252698" ref-type="bibr">8</xref>,<xref | |
| rid="bibr13-15347354241252698" ref-type="bibr">13</xref> | |
| <xref | |
| rid="bibr14-15347354241252698" ref-type="bibr" />-<xref rid="bibr15-15347354241252698" | |
| ref-type="bibr">15</xref></sup> depression,<sup><xref rid="bibr12-15347354241252698" | |
| ref-type="bibr">12</xref>,<xref rid="bibr16-15347354241252698" ref-type="bibr">16</xref></sup> | |
| anxiety, stress,<sup><xref rid="bibr17-15347354241252698" ref-type="bibr">17</xref>,<xref | |
| rid="bibr18-15347354241252698" ref-type="bibr">18</xref></sup> functional disability,<sup> | |
| <xref rid="bibr12-15347354241252698" ref-type="bibr">12</xref> | |
| </sup> survival | |
| outcomes, and prognosis<sup><xref rid="bibr13-15347354241252698" ref-type="bibr">13</xref> | |
| ,<xref rid="bibr18-15347354241252698" ref-type="bibr">18</xref> | |
| <xref | |
| rid="bibr19-15347354241252698" ref-type="bibr" /><xref rid="bibr20-15347354241252698" | |
| ref-type="bibr" />-<xref rid="bibr21-15347354241252698" ref-type="bibr">21</xref></sup> | |
| in cancer survivors.</p> | |
| <p>The pathogenesis of CRF is still unclear, but might include proinflammatory cytokines, | |
| growth factors, circadian rhythm modulation, adrenal axis interruption, serotonin | |
| imbalance, afferent activation of the vagus nerve, and the production or use of abnormal | |
| adenosine triphosphate.<sup> | |
| <xref rid="bibr22-15347354241252698" ref-type="bibr">22</xref> | |
| </sup> Host | |
| factors not related to cancer and its treatment such as genetic, biological, psychosocial, | |
| and behavioral factor also play an important role in the development of CRF.<sup> | |
| <xref rid="bibr23-15347354241252698" ref-type="bibr">23</xref> | |
| </sup></p> | |
| <p>CRF is also associated with various risk factors such as low performance status, | |
| undergoing chemoradiotherapy, insomnia, pain, neuroticism, depression and being female.<sup> | |
| <xref rid="bibr24-15347354241252698" ref-type="bibr">24</xref> | |
| </sup></p> | |
| <p>It is further suggested that cancer-related fatigue is a composite of interacting | |
| responses to stress related to diagnosis and treatment, with the relationship of sleep | |
| disorders, depression, anemia, and inflammation featuring centrally for those under | |
| treatment as well as into the survivorship phase.<sup> | |
| <xref rid="bibr25-15347354241252698" ref-type="bibr">25</xref> | |
| </sup> CRF and a | |
| number of these factors and symptoms, including sleep disruption and emotional distress | |
| often co-occur as a symptom cluster,<sup><xref rid="bibr26-15347354241252698" | |
| ref-type="bibr">26</xref> | |
| <xref rid="bibr27-15347354241252698" ref-type="bibr" />-<xref | |
| rid="bibr28-15347354241252698" ref-type="bibr">28</xref></sup> with some of these | |
| associations potentially linked to the underlying inflammatory biomarker changes such as | |
| cortisol level<sup> | |
| <xref rid="bibr29-15347354241252698" ref-type="bibr">29</xref> | |
| </sup> most | |
| associated with fatigue.<sup><xref rid="bibr3-15347354241252698" ref-type="bibr">3</xref>,<xref | |
| rid="bibr24-15347354241252698" ref-type="bibr">24</xref>,<xref | |
| rid="bibr30-15347354241252698" ref-type="bibr">30</xref></sup></p> | |
| <p>Exploring symptom clusters is an important gap in symptom research to shed light on the | |
| common biological mechanisms<sup> | |
| <xref rid="bibr31-15347354241252698" ref-type="bibr">31</xref> | |
| </sup> and is | |
| gaining increased attention in the field of oncology in an attempt to improve the quality | |
| of life of patients diagnosed with cancer.<sup> | |
| <xref rid="bibr32-15347354241252698" ref-type="bibr">32</xref> | |
| </sup></p> | |
| <p>Hence, there is a need to pay attention to the co-occurrences of fatigue, sleep disorder | |
| and depression as a symptom cluster in the evaluation and treatment of cancer survivors | |
| experiencing CRF.<sup><xref rid="bibr3-15347354241252698" ref-type="bibr">3</xref>,<xref | |
| rid="bibr26-15347354241252698" ref-type="bibr">26</xref> | |
| <xref | |
| rid="bibr27-15347354241252698" ref-type="bibr" />-<xref rid="bibr28-15347354241252698" | |
| ref-type="bibr">28</xref></sup></p> | |
| <p>In spite of fatigue being the most common symptom reported by patients, they were least | |
| likely to report getting wanted help for it, perhaps due to the complexity of treating | |
| this common condition.<sup> | |
| <xref rid="bibr5-15347354241252698" ref-type="bibr">5</xref> | |
| </sup> Given the | |
| multifactorial nature of CRF which is still poorly understood, there is currently no | |
| “gold standard” treatment for CRF despite some approaches such as exercise, | |
| psychosocial interventions, and mind-body interventions being reported to yield beneficial | |
| effects in improving CRF.<sup> | |
| <xref rid="bibr23-15347354241252698" ref-type="bibr">23</xref> | |
| </sup></p> | |
| <p>Emerging studies have shown that mind-body exercise such as Qigong can reduce fatigue, | |
| improve sleep, depression, anxiety, quality of life and cognitive changes associated with | |
| cancer as well as biomarkers of stress, cortisol level, inflammation and immune function | |
| in cancer survivors during and after treatment.<sup><xref rid="bibr29-15347354241252698" | |
| ref-type="bibr">29</xref>,<xref rid="bibr33-15347354241252698" ref-type="bibr">33</xref> | |
| <xref | |
| rid="bibr34-15347354241252698" ref-type="bibr" /><xref rid="bibr35-15347354241252698" | |
| ref-type="bibr" /><xref rid="bibr36-15347354241252698" ref-type="bibr" /><xref | |
| rid="bibr37-15347354241252698" ref-type="bibr" /><xref rid="bibr38-15347354241252698" | |
| ref-type="bibr" /><xref rid="bibr39-15347354241252698" ref-type="bibr" /><xref | |
| rid="bibr40-15347354241252698" ref-type="bibr" /><xref rid="bibr41-15347354241252698" | |
| ref-type="bibr" /><xref rid="bibr42-15347354241252698" ref-type="bibr" /><xref | |
| rid="bibr43-15347354241252698" ref-type="bibr" />-<xref rid="bibr44-15347354241252698" | |
| ref-type="bibr">44</xref></sup></p> | |
| <p>The term “Qigong” is made up of 2 characters: Qi and Gong translated as the | |
| skill or practice to cultivate Qi. The concept of Qi, an inherent function and energizing | |
| essence of human being, is found in Traditional Chinese Medicine.<sup> | |
| <xref rid="bibr45-15347354241252698" ref-type="bibr">45</xref> | |
| </sup> Qi also | |
| refers to life force, vitality, or intelligence within a bio-electric body<sup><xref | |
| rid="bibr46-15347354241252698" ref-type="bibr">46</xref>,<xref | |
| rid="bibr47-15347354241252698" ref-type="bibr">47</xref></sup> as well as the | |
| universe.<sup> | |
| <xref rid="bibr48-15347354241252698" ref-type="bibr">48</xref> | |
| </sup> There are | |
| a few thousand different forms of Qigong such as Tai Chi, BaDuanJin, Chan Chuang, Zhineng | |
| Qigong, and Guolin Qigong, all of which can be broadly classified into Chinese Medical | |
| Qigong, Daoist Qigong, Buddhist Qigong, Confucian Qigong, and martial arts Qigong. All | |
| forms of Qigong involve the recognition and cultivation of Qi to promote a balanced Qi and | |
| smooth flow of Qi in the body<sup> | |
| <xref rid="bibr49-15347354241252698" ref-type="bibr">49</xref> | |
| </sup> to | |
| enhance physical, psychological, and spiritual health through mind-body integration of | |
| specific movements, breathing techniques, and meditation.<sup> | |
| <xref rid="bibr50-15347354241252698" ref-type="bibr">50</xref> | |
| </sup> Mind-body | |
| integration of Qigong is also believed to promote health through the activation of | |
| neurohormonal pathways and other physiological mechanisms.<sup> | |
| <xref rid="bibr51-15347354241252698" ref-type="bibr">51</xref> | |
| </sup> Qigong | |
| offers several potential advantages when compared to modern medical therapy as it | |
| emphasizes a holistic approach with minimal adverse effects<sup><xref | |
| rid="bibr40-15347354241252698" ref-type="bibr">40</xref>,<xref | |
| rid="bibr52-15347354241252698" ref-type="bibr">52</xref></sup> when practiced | |
| correctly after proper guidance. It is also known to improve neuropsychiatric conditions<sup> | |
| <xref rid="bibr53-15347354241252698" ref-type="bibr">53</xref> | |
| </sup> without | |
| the side effects of pharmaceutical drugs. More importantly, it promotes self-empowerment | |
| as it empowers individuals to take an active role in their health. Lastly, Qigong is more | |
| cost- effective compared to certain medical treatments as once learned, it can be | |
| practiced regularly to promote a healthy lifestyle without the need to incur additional | |
| expenses.</p> | |
| <p>Among the many styles of Qigong is Guolin Qigong (GQ). This form of Qigong has been | |
| specifically adapted for cancer survivors by offering a moderate and adaptable exercise | |
| routine. It is a moderate walking exercise that integrates coordinated arm movements and | |
| trunk rotations, coupled with controlled breathing techniques. What sets it apart is its | |
| gentle nature, designed to be accommodating and adjustable. This adaptability is crucial, | |
| as it allows for modifications in speed, duration, and intensity, ensuring that it caters | |
| to the unique health conditions and needs of individual cancer survivors. The flexible | |
| approach of GQ prioritizes the well-being and comfort of each participant, making it a | |
| safe and beneficial practice for those navigating the complexities of cancer recovery. | |
| Therefore GQ is suitable for cancer survivors—especially advanced cancer patients | |
| who may be unable to engage in other forms of physical activity.<sup> | |
| <xref rid="bibr54-15347354241252698" ref-type="bibr">54</xref> | |
| </sup> A | |
| moderate-intensity walking exercise program was reported to be a feasible and effective | |
| intervention method for managing fatigue,<sup><xref rid="bibr55-15347354241252698" | |
| ref-type="bibr">55</xref>,<xref rid="bibr56-15347354241252698" ref-type="bibr">56</xref></sup> | |
| anxiety, depression,<sup> | |
| <xref rid="bibr57-15347354241252698" ref-type="bibr">57</xref> | |
| </sup> and sleep | |
| in cancer survivors at different stages of cancer.<sup><xref | |
| rid="bibr58-15347354241252698" ref-type="bibr">58</xref> | |
| <xref | |
| rid="bibr59-15347354241252698" ref-type="bibr" />-<xref rid="bibr60-15347354241252698" | |
| ref-type="bibr">60</xref></sup> GQ exercise training also facilitates the inhaling of | |
| oxygen which is important for the homeostasis of oxygen-carbon dioxide in controlling | |
| cancer and ultimately survival, as supported by a 10-year longitudinal cohort study of 122 | |
| lung and nasopharyngeal cancer patients which reported that improvements in End Tidal | |
| Breath Holding Time (ETBHT), alveolar O<sub>2</sub> (aO<sub>2</sub>) pressure, and | |
| alveolar CO<sub>2</sub> (aCO<sub>2</sub>) pressure capacity with GQ was associated with | |
| higher survival years, 5 years survival rate and survival probability.<sup> | |
| <xref rid="bibr61-15347354241252698" ref-type="bibr">61</xref> | |
| </sup> In the | |
| above-mentioned cohort study,<sup> | |
| <xref rid="bibr61-15347354241252698" ref-type="bibr">61</xref> | |
| </sup> GQ also | |
| demonstrated improvement in depression among cancer participants. Additionally, in breast | |
| cancer patients undergoing 5 to 6 weeks of radiotherapy, women with elevated | |
| depressive symptoms at the start of treatment showed significant enhancements in fatigue | |
| and QOL.<sup> | |
| <xref rid="bibr50-15347354241252698" ref-type="bibr">50</xref> | |
| </sup></p> | |
| <p>However, the impact of GQ on CRF, often associated with sleep and depression<sup><xref | |
| rid="bibr3-15347354241252698" ref-type="bibr">3</xref>,<xref | |
| rid="bibr26-15347354241252698" ref-type="bibr">26</xref> | |
| <xref | |
| rid="bibr27-15347354241252698" ref-type="bibr" />-<xref rid="bibr28-15347354241252698" | |
| ref-type="bibr">28</xref></sup> and its correlation with cortisol levels has not been | |
| explored.</p> | |
| <p>In addition to that, a qualitative study to evaluate the perception and acceptance of GQ | |
| is needed to explore the feasibility, adherence, and experience related to this complex | |
| intervention. It aims to understand the more subjective domains and identify potential | |
| factors for improving healthcare<sup> | |
| <xref rid="bibr62-15347354241252698" ref-type="bibr">62</xref> | |
| </sup> to | |
| address the multi-faceted needs of this population. Such research, however, has not been | |
| conducted yet.</p> | |
| <p>Therefore, the purpose of this paper is to describe the protocol of a mixed-method study | |
| comprising,</p> | |
| <list list-type="order" id="list1-15347354241252698"> | |
| <list-item> | |
| <p>A randomized-controlled trial to evaluate the feasibility of GQ training and its | |
| effect on CRF, sleep, depression, and cortisol levels in breast, lung and colon cancer | |
| survivors and,</p> | |
| </list-item> | |
| <list-item> | |
| <p>Semi-structured interview with study participants from the randomized- controlled | |
| trial to understand their perceptions and experiences of GQ to identify: <list | |
| list-type="simple" id="list2-15347354241252698"> | |
| <list-item> | |
| <p>(a) other physiological and psychological benefits gained from the GQ | |
| intervention,</p> | |
| </list-item> | |
| <list-item> | |
| <p>(b) the barriers to GQ participation, adherence, and recommendations for | |
| improvement.</p> | |
| </list-item> | |
| </list></p> | |
| </list-item> | |
| </list> | |
| <p>We hypothesized that</p> | |
| <list list-type="order" id="list3-15347354241252698"> | |
| <list-item> | |
| <p>It is feasible for cancer survivor participants to engage in the GQ training and | |
| those who participated in the GQ training will experience positive impacts on CRF, | |
| sleep, depression, and cortisol level. Feasibility of this study is established at | |
| about 80% to 85% retention rate and 75% to 85% class attendance rate based on prior | |
| similar studies.<sup><xref rid="bibr63-15347354241252698" ref-type="bibr">63</xref> | |
| <xref | |
| rid="bibr64-15347354241252698" ref-type="bibr" />-<xref | |
| rid="bibr65-15347354241252698" ref-type="bibr">65</xref></sup></p> | |
| </list-item> | |
| <list-item> | |
| <p>The semi-structured interview will identify a broader spectrum of benefits and | |
| barriers to participation and adherence to GQ training to provide valuable insights | |
| for program enhancement.</p> | |
| </list-item> | |
| </list> | |
| </sec> | |
| <sec sec-type="methods" id="section6-15347354241252698"> | |
| <title>Methods</title> | |
| <sec id="section7-15347354241252698"> | |
| <title>Study Design</title> | |
| <sec id="section8-15347354241252698"> | |
| <title>Intervention/clinical trial</title> | |
| <p>The primary objective of this study is to explore the feasibility of a GQ | |
| intervention in patients with various cancer types who experience CRF. This study | |
| includes the 3 most prevalent cancer types that is, breast, lung and colon cancers. | |
| This is a randomized-controlled trial that compares the GQ intervention group to a | |
| usual care waitlist control group receiving standard medical care allocated in a 1:1 | |
| ratio to evaluate the feasibility and effects of a 12-week GQ intervention on 60 | |
| eligible breast, lung, and colorectal cancer survivors’ fatigue, sleep quality, | |
| depression, and 24-hour urine cortisol change. Refer to <xref | |
| rid="fig1-15347354241252698" ref-type="fig">Figure 1</xref> for an overview of the | |
| study. This study protocol was developed based on the SPIRIT 2013 Statement (Standard | |
| Protocol Items: Recommendations for Interventional Trials) (<ext-link | |
| xlink:href="https://journals.sagepub.com/doi/suppl/10.1177/15347354241252698" | |
| ext-link-type="uri">Supplemental Material 1</ext-link>).<sup> | |
| <xref rid="bibr66-15347354241252698" ref-type="bibr">66</xref> | |
| </sup></p> | |
| <fig position="float" id="fig1-15347354241252698"> | |
| <label>Figure 1.</label> | |
| <caption> | |
| <p>Participant flow diagram.</p> | |
| </caption> | |
| <graphic xlink:href="10.1177_15347354241252698-fig1" position="float" /> | |
| </fig> | |
| </sec> | |
| <sec id="section9-15347354241252698"> | |
| <title>Interview</title> | |
| <p>We will use a qualitative descriptive design, with a semi-structured interview to | |
| collect in-depth information to enhance our understanding of the perceptions and | |
| experiences of GQ participation of cancer survivors based on purposive sampling until | |
| data saturation is reached.</p> | |
| <p>The qualitative interview will be reported within the primary randomized feasibility | |
| trial according to the guidelines recommended in the CONSORT 2010 statement extension.<sup> | |
| <xref rid="bibr67-15347354241252698" ref-type="bibr">67</xref> | |
| </sup></p> | |
| </sec> | |
| </sec> | |
| <sec id="section10-15347354241252698"> | |
| <title>Study Setting</title> | |
| <p>The trial is conducted at University Malaya Medical Centre (UMMC) in Kuala Lumpur, | |
| Malaysia. Participants are recruited by referrals from UMMC or online and print | |
| advertisements such as posting recruitment in UMMC, cancer support groups, GQ | |
| Association and GQ practice stations around Klang Valley, and social media platforms | |
| including X Corp (formerly known as Twitter) and Facebook.</p> | |
| </sec> | |
| <sec id="section11-15347354241252698"> | |
| <title>Recruitment</title> | |
| <p>Recruitment started in October 2022. Upon first contact, the Researcher will screen | |
| potential breast, lung, or colon cancer survivors and provide information about the | |
| study to those who meet the eligibility criteria and indicate interest to participate. | |
| Thereafter a Physician/Oncologist Screening Form, Participant Information Sheet, and 2 | |
| copies of Participant Consent Form will be given, explained, and a separate date agreed | |
| for in-person enrollment.<sup> | |
| <xref rid="bibr67-15347354241252698" ref-type="bibr">67</xref> | |
| </sup></p> | |
| </sec> | |
| <sec id="section12-15347354241252698"> | |
| <title>Inclusion Criteria</title> | |
| <list list-type="simple" id="list4-15347354241252698"> | |
| <list-item> | |
| <p>(1) Age ≥ 18 years old;</p> | |
| </list-item> | |
| <list-item> | |
| <p>(2) *Cancer survivor diagnosed with breast, lung and colorectal cancer;</p> | |
| </list-item> | |
| <list-item> | |
| <p>(3) Able to read and answer questionnaires in English and/or Bahasa Malaysia | |
| language by oneself;</p> | |
| </list-item> | |
| <list-item> | |
| <p>(4) Suffering from moderate to severe fatigue as assessed by the simple | |
| fatigue scale; with severity score of 3 and above<sup> | |
| <xref rid="bibr68-15347354241252698" ref-type="bibr">68</xref> | |
| </sup> | |
| ;</p> | |
| </list-item> | |
| <list-item> | |
| <p>(5) Able to use smart phones and the WeChat or WhatsApp application;</p> | |
| </list-item> | |
| <list-item> | |
| <p>(6) Life expectancy of more than 3 months;</p> | |
| </list-item> | |
| <list-item> | |
| <p>(7) Able to give informed consent;</p> | |
| </list-item> | |
| <list-item> | |
| <p>(8) Available and willing to comply with the study requirements.</p> | |
| </list-item> | |
| </list> | |
| <p>*A cancer survivor is defined as an individual diagnosed with cancer through the | |
| balance of life according to National Cancer Institute.<sup> | |
| <xref rid="bibr69-15347354241252698" ref-type="bibr">69</xref> | |
| </sup></p> | |
| <p>Including cancer survivors throughout the continuum of survivorship in our sample | |
| inclusion criteria allows us to capture a comprehensive spectrum of experiences. From | |
| those newly diagnosed to long-term survivors, each stage brings unique perspectives on | |
| GQ participation and its impact. This approach ensures a thorough exploration of how GQ | |
| intervention intersects with varying phases of the cancer journey, providing a rich | |
| understanding of the diverse narratives and challenges encountered across this | |
| continuum.</p> | |
| </sec> | |
| <sec id="section13-15347354241252698"> | |
| <title>Exclusion Criteria</title> | |
| <list list-type="simple" id="list5-15347354241252698"> | |
| <list-item> | |
| <p>(1) Cardiopulmonary disease, nerve, muscle, or joint disease, or other | |
| malignant tumors affecting movement;</p> | |
| </list-item> | |
| <list-item> | |
| <p>(2) Mental illness or serious cognitive impairment and defects in language | |
| that significantly impairs communication;</p> | |
| </list-item> | |
| <list-item> | |
| <p>(3) Post-operative heart, cerebral vessel, or other serious complications;</p> | |
| </list-item> | |
| <list-item> | |
| <p>(4) Neurological degenerative disease (e.g. dementia), reduced cognitive; | |
| capacity in any way that would affect ability to understand trial procedures and | |
| give informed consent;</p> | |
| </list-item> | |
| <list-item> | |
| <p>(5) Patients who are not able to walk;</p> | |
| </list-item> | |
| <list-item> | |
| <p>(6) Other medical conditions which would preclude study intervention or make | |
| study participation unsafe such as severe chronic heart failure.</p> | |
| </list-item> | |
| </list> | |
| </sec> | |
| <sec id="section14-15347354241252698"> | |
| <title>Randomization and Blinding</title> | |
| <p>After informed consent, participants will be randomly assigned to either the GQ or | |
| usual care waitlist control group at a 1:1 ratio with the random sequence generated by | |
| an online computerized randomization system using minimization method<sup><xref | |
| rid="bibr70-15347354241252698" ref-type="bibr">70</xref> | |
| <xref | |
| rid="bibr71-15347354241252698" ref-type="bibr" />-<xref | |
| rid="bibr72-15347354241252698" ref-type="bibr">72</xref></sup> by an independent | |
| research assistant.</p> | |
| </sec> | |
| <sec id="section15-15347354241252698"> | |
| <title>Intervention</title> | |
| <p>After being advised of group allocation, the study participant will be given a few days | |
| to decide on whether to proceed with enrollment. Incorporating a brief period for | |
| participants to reflect and opt-out after randomization supports ethical research | |
| practices, ensures ethical informed consent, reduces pressure, enhances retention, and | |
| respects participant autonomy in clinical trials or studies.</p> | |
| <sec id="section16-15347354241252698"> | |
| <title>Guolin Qigong</title> | |
| <p>Participants in the intervention group will attend a 2-hour supervised face-to-face | |
| (F2F) GQ training class for 12 weeks with home-practice on non-class days. | |
| There will be 2 training classes per week for the first 2 weeks and once per | |
| week for the next 10 weeks.</p> | |
| <p>The GQ training involves a modified version of a Chinese medical qigong therapy often | |
| referred to as “walking qigong” developed by Guo Lin.<sup> | |
| <xref rid="bibr38-15347354241252698" ref-type="bibr">38</xref> | |
| </sup> | |
| GQ was developed specifically for cancer and consisted of several breathing and moving | |
| exercises. The GQ training in the current study includes the following 3 main | |
| exercises:</p> | |
| <list list-type="simple" id="list6-15347354241252698"> | |
| <list-item> | |
| <p>1. Feng Hu Xi Zhi Ran Xing Gong (Natural Wind Breathing Walking)</p> | |
| </list-item> | |
| </list> | |
| <p>Participants walk in a circle, synchronizing their breathing, arm movements, and | |
| steps focusing on the movement of their body with the goal of calming one’s | |
| mind, relaxing various parts of the body and the mind, and revitalizing the | |
| “life-force,” that is, <italic toggle="yes">qi</italic>.</p> | |
| <list list-type="simple" id="list7-15347354241252698"> | |
| <list-item> | |
| <p>2. Dian Bu Gong (Step Tap Method)</p> | |
| </list-item> | |
| </list> | |
| <p>A modified natural Wind Breathing Walking Exercise with additional step tap.</p> | |
| <list list-type="simple" id="list8-15347354241252698"> | |
| <list-item> | |
| <p>3. Sheng Jiang Kai He Fa (Ascending, Descending, Opening, and Closing | |
| Method)</p> | |
| </list-item> | |
| </list> | |
| <p>A calming and relaxation method of synchronized arms and legs movements on the spot | |
| which can be practiced within limited space.</p> | |
| <p>Each main exercise has to be practiced separately as individual sets comprising 3 | |
| parts:</p> | |
| <list list-type="simple" id="list9-15347354241252698"> | |
| <list-item> | |
| <p>a. Preparatory relaxation exercise (gentle breathing and meditation; | |
| 4 minutes):</p> | |
| </list-item> | |
| </list> | |
| <p>In relaxed standing posture, synchronize the breath with gentle arm movements in | |
| front of the abdomen (opening and closing of the Dantian). Dantian is a Chinese | |
| medicine concept that refers to the “elixir field” or “energy | |
| center.” It has different locations but often referred to the lower abdomen | |
| between the navel and pubic bone of the human body.<sup><xref | |
| rid="bibr73-15347354241252698" ref-type="bibr">73</xref>,<xref | |
| rid="bibr74-15347354241252698" ref-type="bibr">74</xref></sup></p> | |
| <list list-type="simple" id="list10-15347354241252698"> | |
| <list-item> | |
| <p>b. Main exercise</p> | |
| </list-item> | |
| <list-item> | |
| <p>i. Feng Hu Xi Zhi Ran Xing Gong (Natural Wind Breathing Walking) or</p> | |
| </list-item> | |
| <list-item> | |
| <p>ii. Dian Bu Gong (Step Tap Method) or</p> | |
| </list-item> | |
| <list-item> | |
| <p>iii. Sheng Jiang Kai He Fa (Ascending, Descending, Opening, and Closing | |
| Method).</p> | |
| </list-item> | |
| <list-item> | |
| <p>c. Concluding exercise: breathing exercises, opening, and closing of the | |
| Dantian, and self-massage (3-6 minutes).<sup> | |
| <xref rid="bibr50-15347354241252698" ref-type="bibr">50</xref> | |
| </sup></p> | |
| </list-item> | |
| </list> | |
| <p>Please refer to <ext-link | |
| xlink:href="https://journals.sagepub.com/doi/suppl/10.1177/15347354241252698" | |
| ext-link-type="uri">Supplemental Material 2</ext-link> for detailed steps. All | |
| movements will include modifications to enhance safety. Participants will be advised | |
| to rest as and when necessary, according to their health status.</p> | |
| <p>The F2F GQ class will be taught by qualified GQ instructors who are both long-term | |
| cancer survivors with more than 20 years of GQ training experience to ensure | |
| the full potential of the GQ intervention. The Researcher, who is a registered Chinese | |
| Medicine practitioner in Malaysia and Australia with more than 20 years’ | |
| experience in Qigong, will be in attendance during the F2F GQ class to ensure the safe | |
| and seamless facilitation of the training session.</p> | |
| <p>Home practice is recommended for non-class days according to individual health status | |
| and available time.<sup> | |
| <xref rid="bibr54-15347354241252698" ref-type="bibr">54</xref> | |
| </sup> | |
| Participants will be provided with class notes and video links (<ext-link | |
| xlink:href="https://journals.sagepub.com/doi/suppl/10.1177/15347354241252698" | |
| ext-link-type="uri">Supplemental Material 3</ext-link>) to promote and support home | |
| practice. Home practice after the intervention period is encouraged for incorporation | |
| into daily life to foster a healthy lifestyle.</p> | |
| </sec> | |
| </sec> | |
| <sec id="section17-15347354241252698"> | |
| <title>Usual Care Waitlist Control</title> | |
| <p>Participants in the usual care waitlist control group will be advised to continue with | |
| their usual care routines and exercises and will be asked not to attend any other Qigong | |
| exercises. They will be offered to attend the same GQ training class after Week-16 of | |
| the GQ training of their cohort.</p> | |
| <p>However, to maintain integrity of the study, instructors will not be informed about the | |
| allocation of participants. Consequently, when instructors commence training of | |
| subsequent cohorts, they will be unaware of which participants belong to the | |
| intervention group (commencing from Week 1), and which are part of the control group | |
| (joining the GQ group in Week 1), given the GQ training will be offered continuously. | |
| This ensures the instructors are effectively blinded to the allocation to maintain | |
| impartiality in the delivery of the training and minimizes any potential biases that may | |
| arise from instructor knowledge of group allocation.</p> | |
| </sec> | |
| <sec id="section18-15347354241252698"> | |
| <title>Study Assessments</title> | |
| <p>The variables under consideration will encompass basic demographic data, primary | |
| outcomes, and secondary outcomes. Basic characteristics will be collected at baseline | |
| (Week-1).</p> | |
| <p>Primary feasibility outcomes on adherence, attendance, and any adverse events will be | |
| recorded throughout the intervention period from Week-1 to Week-12 in the practice diary | |
| by the participants. Secondary patient-reported outcomes on fatigue, depression, and | |
| sleep will be measured at baseline (Week-1), mid-intervention (Week-6), | |
| post-intervention (Week-12), and 4 weeks after completion of intervention | |
| (Week-16). Urine samples (for urine cortisol test) to assess 24-hour urinary cortisol | |
| will be collected a day prior to enrollment date and post-intervention (Week-12). | |
| Primary feasibility outcomes and secondary patient-reported outcomes will be assessed by | |
| an independent research assistant to minimize bias. A summary of the planned data | |
| collection is shown in <xref rid="fig2-15347354241252698" ref-type="fig">Figure 2</xref> | |
| .</p> | |
| <fig position="float" id="fig2-15347354241252698"> | |
| <label>Figure 2.</label> | |
| <caption> | |
| <p>Schedule of enrollment, intervention and data collection</p> | |
| <p>Abbreviations: BFI, Brief Fatigue Inventory, CES-D, Centre for Epidemiologic | |
| Studies Depression; PSQI, Pittsburgh Sleep Quality Index.</p> | |
| </caption> | |
| <graphic xlink:href="10.1177_15347354241252698-fig2" position="float" /> | |
| </fig> | |
| <sec id="section19-15347354241252698"> | |
| <title>Basic demographic data</title> | |
| <p>Participants’ basic characteristics (sex, marital status, age) and cancer | |
| history will be collected using a self-designed questionnaire.</p> | |
| </sec> | |
| <sec id="section20-15347354241252698"> | |
| <title>Feasibility outcomes</title> | |
| <p>Feasibility will be assessed based on recruitment rate, retention rate, class | |
| attendance, home practice adherence, the nature and extent of missing data, and | |
| safety. Safety will be monitored and assessed based on total number of Adverse Event | |
| and the presence of any Serious Adverse Event.<sup> | |
| <xref rid="bibr75-15347354241252698" ref-type="bibr">75</xref> | |
| </sup></p> | |
| </sec> | |
| <sec id="section21-15347354241252698"> | |
| <title>Patient-reported outcomes and cortisol biomarker</title> | |
| <list list-type="simple" id="list11-15347354241252698"> | |
| <list-item> | |
| <p>i. Patient-reported outcomes</p> | |
| </list-item> | |
| </list> | |
| <p>Participants will complete several patient-reported outcome measures to evaluate | |
| fatigue—Brief Fatigue Inventory (BFI),<sup> | |
| <xref rid="bibr68-15347354241252698" ref-type="bibr">68</xref> | |
| </sup> | |
| sleep quality—Pittsburgh Sleep Quality Index (PSQI)<sup> | |
| <xref rid="bibr76-15347354241252698" ref-type="bibr">76</xref> | |
| </sup> | |
| and depression—Centre for Epidemiologic Studies Depression (CES-D)<sup><xref | |
| rid="bibr77-15347354241252698" ref-type="bibr">77</xref>,<xref | |
| rid="bibr78-15347354241252698" ref-type="bibr">78</xref></sup> at Week-1, Week-6, | |
| Week-12, and Week-16.</p> | |
| <list list-type="simple" id="list12-15347354241252698"> | |
| <list-item> | |
| <p>a. Fatigue—The Brief Fatigue Inventory (BFI)</p> | |
| </list-item> | |
| </list> | |
| <p>The BFI was developed for the rapid assessment of fatigue severity in cancer patients | |
| for use in both clinical screening and clinical trials. It is easy to administer, and | |
| patients can complete them easily as it has only 9 items with simple wordings that are | |
| easy to understand and translate.<sup> | |
| <xref rid="bibr68-15347354241252698" ref-type="bibr">68</xref> | |
| </sup> | |
| Items 1 to 3 rate participants’ worst, usual, and current fatigue during the | |
| past 24 hours using a visual analog scale (VAS) ranging from 0 (no fatigue) to | |
| 10 (very severely fatigued). A composite fatigue severity score was obtained by | |
| averaging the 3 severity scores. The remaining 6 items rate the level at which | |
| patients` fatigue interferes with certain functions such as daily activity, work, | |
| walking ability, normal work, relations with others, and enjoyment in life. Each item | |
| is rated on a scale of 0 (does not interfere) to 10 (completely interferes). A | |
| composite fatigue interference score will be obtained by averaging the scores of the 6 | |
| interference items. Severity scores of 1 to 3 suggest mild fatigue, 4 to 6 moderate, | |
| and 7 to 10 represent severe fatigue. The internal consistency Cronbach’s | |
| α at .96 supports the reliability of BFI which is correlated with measures of | |
| performance status (patients who are more ill reported higher levels of fatigue).<sup> | |
| <xref rid="bibr68-15347354241252698" ref-type="bibr">68</xref> | |
| </sup></p> | |
| <list list-type="simple" id="list13-15347354241252698"> | |
| <list-item> | |
| <p>b. Sleep—Pittsburgh Sleep Quality Index (PSQI)</p> | |
| </list-item> | |
| </list> | |
| <p>The PSQI, proposed by Buysse et al<sup> | |
| <xref rid="bibr76-15347354241252698" ref-type="bibr">76</xref> | |
| </sup> | |
| in 1989, is currently the most commonly used scale for assessing sleep quality. The | |
| PSQI is a 19-item scale measuring 7 aspects of the sleep quality and disturbances, | |
| that is, subjective sleep quality, sleep latency, duration, efficiency, disturbances, | |
| use of sleep medication, and daytime sleep dysfunction, each weighted equally on a 0 | |
| to 3 scale. The total score ranges between 0 and 21, with increasing scores indicating | |
| worse sleep quality.<sup> | |
| <xref rid="bibr76-15347354241252698" ref-type="bibr">76</xref> | |
| </sup> | |
| It has a sensitivity of 89.6% and a specificity of 86.5% to detect insomnia cases and | |
| is a useful first-line, easy-to-handle, and time-efficient questionnaire to evaluate | |
| sleep quality.<sup> | |
| <xref rid="bibr79-15347354241252698" ref-type="bibr">79</xref> | |
| </sup> | |
| The PSQI was reported to be a stable measure of sleep quality with high test-retest | |
| reliability and construct validity.<sup><xref rid="bibr79-15347354241252698" | |
| ref-type="bibr">79</xref>,<xref rid="bibr80-15347354241252698" ref-type="bibr">80</xref></sup></p> | |
| <list list-type="simple" id="list14-15347354241252698"> | |
| <list-item> | |
| <p>c. Depression—Centre for Epidemiologic Studies Depression (CES-D)</p> | |
| </list-item> | |
| </list> | |
| <p>The CES-D is a short self-reported 20-item scale<sup> | |
| <xref rid="bibr81-15347354241252698" ref-type="bibr">81</xref> | |
| </sup> | |
| to be administered to measure depression symptoms at baseline, mid-intervention, | |
| post-intervention, and follow-up. The CES-D shows very high internal consistency and | |
| adequate test-retest repeatability.<sup> | |
| <xref rid="bibr81-15347354241252698" ref-type="bibr">81</xref> | |
| </sup> | |
| The score is the sum of all items, and the maximum score is 60. | |
| Scores ≥ 16 on the CES-D is considered as having | |
| “depressed symptoms.” The cut off score of 12 has been validated with | |
| DSM-III criteria for clinical depression.<sup><xref rid="bibr81-15347354241252698" | |
| ref-type="bibr">81</xref>,<xref rid="bibr82-15347354241252698" ref-type="bibr">82</xref></sup></p> | |
| <list list-type="simple" id="list15-15347354241252698"> | |
| <list-item> | |
| <p>ii. Cortisol biomarker: 24-hour urine cortisol</p> | |
| </list-item> | |
| </list> | |
| <p>Urine sample will be collected at baseline (Week-1) and post-intervention (Week- 12).<sup> | |
| <xref rid="bibr83-15347354241252698" ref-type="bibr">83</xref> | |
| </sup> | |
| Participants are briefed on the urine collection procedure during assessment and | |
| advised to obtain the 2.5 L urine collection container from any nearby BP | |
| Laboratories before baseline (Week-1) and post-intervention (Week-12). We use 24-hour | |
| urinary cortisol as a non-invasive, integrated measure of cortisol stress hormone | |
| activity that could be collected in participants’ home environments. | |
| Participants are instructed to collect all urine for 24 hours from 8:00am a day | |
| prior to baseline (Week-1) and post-intervention (Week-12) to 8:00am the next mornings | |
| and to send the urine sample collected to the nearest BP Laboratories the next morning | |
| itself. If the 2.5L collection container is completely full, subjects are advised to | |
| use a clean mineral water bottle to collect any specimen in excess of the 2.5 L | |
| collection. If subjects are unable to collect all urine for any reason, their samples | |
| will be deemed inadequate and no urinary cortisol data will be recorded for these | |
| subjects.</p> | |
| <p>The 24-hour urine cortisol test provides a more accurate estimate of overall cortisol | |
| secretion<sup> | |
| <xref rid="bibr84-15347354241252698" ref-type="bibr">84</xref> | |
| </sup> | |
| to assess urinary-free cortisol (UFC) over a 24-hour period and provides an index of | |
| (unbound serum cortisol) the total amount of cortisol released by the adrenals. The | |
| 24-hour collection time reflects the amount of cortisol that is released over a | |
| complete circadian cycle, which is a physiologically meaningful unit of time. An | |
| integrated mean of cortisol levels over a 24-hour period is thought to provide a | |
| moderately stable measure of adrenocortical output.<sup> | |
| <xref rid="bibr85-15347354241252698" ref-type="bibr">85</xref> | |
| </sup> | |
| Urinary cortisol output will be analyzed by chemiluminescent microparticle immunoassay | |
| (CMIA) at BP Laboratories, headquartered in Shah Alam, Selangor Darul Ehsan, Malaysia.</p> | |
| </sec> | |
| <sec id="section22-15347354241252698"> | |
| <title>Qualitative interview</title> | |
| <p>Semi-structured interviews will be conducted to inform interpretation of quantitative | |
| results and participants’ acceptance, experience, and subjective perception of | |
| the study as well as to find out areas for further improvement<sup> | |
| <xref rid="bibr86-15347354241252698" ref-type="bibr">86</xref> | |
| </sup> | |
| after Week-16.</p> | |
| <p>A prepared interview guide (<ext-link | |
| xlink:href="https://journals.sagepub.com/doi/suppl/10.1177/15347354241252698" | |
| ext-link-type="uri">Supplemental Material 4</ext-link>) is designed to delve into | |
| participants’ experiences and will be used in the interview to cover 3 primary | |
| themes: the experiences of practicing GQ, changes in the physical and emotional state, | |
| and suitability of GQ for cancer survivors. Examples of questions to be asked are | |
| “How do you feel about the 12 weeks of Guolin Qigong study?,” | |
| “Have you had other benefits from this Guolin Qigong study?,” and | |
| “Would you recommend Guolin Qigong to other cancer survivors? Why? Why | |
| not?.”</p> | |
| <p>Each interview will take approximately 45 minutes and will be audio-recorded | |
| and transcribed verbatim by the Researcher.</p> | |
| </sec> | |
| </sec> | |
| </sec> | |
| <sec id="section23-15347354241252698"> | |
| <title>Protocol Amendments</title> | |
| <p>The Researcher is responsible for submitting materials to the human ethics committee.</p> | |
| <sec id="section24-15347354241252698"> | |
| <title>Trial Monitoring</title> | |
| <p>The Researcher will report progress of the trial to the panel of supervisors on a | |
| quarterly basis. Annual reports will be submitted to the human ethics committee to | |
| monitor the trial progress and outcomes. Participants in the GQ group will be advised to | |
| record any perceived adverse events in the practice diary and this will be recorded in | |
| participants’ Adverse Event Form by the Researcher. The severity, expectedness | |
| and causal relationship with GQ intervention will be assessed for every adverse event | |
| according to guidelines for safety reporting.<sup><xref rid="bibr75-15347354241252698" | |
| ref-type="bibr">75</xref>,<xref rid="bibr87-15347354241252698" ref-type="bibr">87</xref></sup></p> | |
| <p>The schedule of the enrollment, intervention, and data collection is shown in <xref | |
| rid="fig2-15347354241252698" ref-type="fig">Figure 2</xref>.</p> | |
| </sec> | |
| <sec id="section25-15347354241252698"> | |
| <title>Sample Size</title> | |
| <p>Using a small effect size (0.2)<sup> | |
| <xref rid="bibr65-15347354241252698" ref-type="bibr">65</xref> | |
| </sup> | |
| rather than a medium effect size (0.5)<sup> | |
| <xref rid="bibr64-15347354241252698" ref-type="bibr">64</xref> | |
| </sup> to | |
| achieve a more conservative estimation, the sample size is 25 cases in each group with | |
| 90% power and two-sided 5% significance trial design.<sup> | |
| <xref rid="bibr88-15347354241252698" ref-type="bibr">88</xref> | |
| </sup> | |
| Allowing for a drop-out of about 20% based on previous studies,<sup><xref | |
| rid="bibr89-15347354241252698" ref-type="bibr">89</xref> | |
| <xref | |
| rid="bibr90-15347354241252698" ref-type="bibr" /><xref | |
| rid="bibr91-15347354241252698" ref-type="bibr" />-<xref | |
| rid="bibr92-15347354241252698" ref-type="bibr">92</xref></sup> a total sample of 60 | |
| (30 in each group) would be required.</p> | |
| </sec> | |
| <sec id="section26-15347354241252698"> | |
| <title>Data Collection</title> | |
| <p>De-identified information will be collected and managed by assigning an identification | |
| code to each participant. Demographic information, medical history, any occurrence of | |
| adverse events, practice adherence and intervention outcomes during the study will be | |
| collected and recorded on paper or electronic file.</p> | |
| <p>Demographic information and medical history will first be collected by the Researcher. | |
| De-identified Practice Diary, Brief Fatigue Index, Pittsburgh Sleep Quality Index, and | |
| Centre for Epidemiologic Studies Depression will be collected at Week-1, Week-6, | |
| Week-12, and Week-16, while the 24-hour urine cortisol results will be collected by the | |
| research assistant at Week-1 and Week-12. Interviews will be conducted by the Researcher | |
| after Week-16, audio-recorded, de-identified, and transcribed verbatim.</p> | |
| <p>During the study, all data will be recorded in participant source document files in | |
| paper format (sociodemographic data, feasibility and clinical data), administered by | |
| independent research assistants and will be transferred to an electronic format for | |
| storage and analysis. The 2 independent research assistants will verify and check the | |
| data collected by each other. After all data are confirmed and checked the research | |
| assistants will extract the data into an Excel sheet for analysis.</p> | |
| <p>After participants have been randomized, dropout and premature termination or | |
| withdrawal from the 2 groups at any point will be recorded along with relevant reasons. | |
| Participants can choose to withdraw and will not be affected at any time while declining | |
| to participate or withdrawing from the trial. In some cases, participants will | |
| discontinue the intervention, such as illness, progression of their disease, or | |
| inability to engage despite adjustment of the program. Participants who withdraw from | |
| the intervention during the trial will not be replaced.</p> | |
| <p>Interviews will be conducted after Week-16 in person or online via Zoom by the | |
| Researcher at an appointed time. Interview sessions will be audio recorded and | |
| transcribed verbatim using NVivo or the recording feature available in Zoom, ensuring | |
| accurate documentation, and stored in electronic files for analysis.</p> | |
| </sec> | |
| <sec id="section27-15347354241252698"> | |
| <title>Data Management</title> | |
| <p>De-identified electronic data will be stored on a password-protected computer. Files | |
| will be accessible for review only to the research team. Specific requests will be | |
| needed from the supervisory panel for any access by any other person. All completed | |
| forms and study information will be de-identified and stored in a locked filing cabinet | |
| together with consent forms at UMMC.</p> | |
| <p>The information collected will be securely locked and only accessible to the research | |
| personnel. The data will be de-identified for analysis and once date is coded, all | |
| identifiable information will be destroyed. All data collected in the study will be | |
| destroyed 7 years after publication.</p> | |
| </sec> | |
| </sec> | |
| <sec id="section28-15347354241252698"> | |
| <title>Data Analysis</title> | |
| <sec id="section29-15347354241252698"> | |
| <title>Quantitative Data</title> | |
| <p>Data analysis will be conducted by an independent statistician. Data analysis will be | |
| by intention to treat using last observation carried forward (LOCF).<sup> | |
| <xref rid="bibr93-15347354241252698" ref-type="bibr">93</xref> | |
| </sup> The | |
| normality of the study data will be checked by examining the mean, median, skewness, and | |
| kurtosis including graphical representation of the box plot, normal Q-Q Plot or | |
| histogram. Continuous data will be summarized using descriptive statistics including the | |
| number of observations used in the calculation (<italic toggle="yes">n</italic>), mean, | |
| standard deviation (SD), minimum, median and maximum. Categorical data will be | |
| summarized as counts and percentages of each category. Between group comparison will be | |
| conducted using the t test, chi-square test, or Fisher exact test, as | |
| appropriate. We will report the results for two-sided 5% tests for the primary trial | |
| outcome. We will use generalized linear mixed model (GLMM). The outcomes of the model | |
| will be BFI, PSQI, CES-D scores, and 24-hour urine cortisol test results. Models will | |
| include the treatment group as a fixed effect, with time as a random effect to account | |
| for the repeated measurements. Analyses will be conducted to identify the baseline | |
| characteristics of the participants who may benefit most from the intervention. Model | |
| assumptions will be checked and appropriate adjustments to the analysis will be made | |
| where necessary. STATA<sup>®</sup> software version 17.1 (2021; Stata Corporation, | |
| College Station, TX, USA) will be used for all analyses. Cohen’s D will be | |
| calculated as the absolute differences between the mean change in the variable divided | |
| by pooled variance of the change.</p> | |
| </sec> | |
| <sec id="section30-15347354241252698"> | |
| <title>Qualitative Data</title> | |
| <p>The researcher will conduct an interview consisting of 6 pre-determined open-ended | |
| questions (Refer <ext-link | |
| xlink:href="https://journals.sagepub.com/doi/suppl/10.1177/15347354241252698" | |
| ext-link-type="uri">Supplemental Material 4</ext-link>) that were identified from | |
| literature review and based on research questions outlined in the study. Probing | |
| questions will only be asked where clarification or expansion of expressed ideas is | |
| required. Interviews will be conducted until data saturation is reached. Interview | |
| transcripts will be analyzed using the inductive qualitative content analysis approach | |
| to provide a comprehensive descriptive summary of the interviewee’s experience | |
| and perception of GQ in everyday terms.<sup> | |
| <xref rid="bibr94-15347354241252698" ref-type="bibr">94</xref> | |
| </sup> All | |
| audio recordings of the interview will be transcribed verbatim with NVivo or Zoom. | |
| First, to obtain an overall impression, the transcribed materials will be read several | |
| times thoroughly. Then, sentences or phrases will be condensed and divided into | |
| ideas/meaning units. The ideas/meaning units are further condensed, abstracted, and | |
| conceived into the categories. All categories will be put together and compared, based | |
| on differences and similarities and group together to create themes. This iterative | |
| approach to analysis will be conducted until no new ideas/codes emerge and saturation is | |
| achieved. A second reviewer will review each phase of the process. A summary of each | |
| theme and supporting quotes from participants will be generated and shared with the | |
| study team to review independently. Data analysis will be repeated in this manner until | |
| a final consensus is reached on final themes to ensure validity.<sup><xref | |
| rid="bibr95-15347354241252698" ref-type="bibr">95</xref>,<xref | |
| rid="bibr96-15347354241252698" ref-type="bibr">96</xref></sup> The Consolidated | |
| Criteria for Reporting Qualitative Research (COREQ)<sup> | |
| <xref rid="bibr62-15347354241252698" ref-type="bibr">62</xref> | |
| </sup> will | |
| be used for reporting the findings.</p> | |
| </sec> | |
| <sec id="section31-15347354241252698"> | |
| <title>Trial Registration and Ethical Issues</title> | |
| <p>This study has been registered with ANZCTR (ACTRN12622000688785p), was approved by | |
| Medical Research Ethic Committee of University Malaya Medical Centre (MREC ID NO: | |
| 2022323-11092) and recognized by Western Sydney University Human Research Ethics | |
| Committee (RH15124).</p> | |
| </sec> | |
| <sec id="section32-15347354241252698"> | |
| <title>Dissemination</title> | |
| <p>The results of this study will be reported in a PhD thesis by the first author and | |
| submitted for publication following the rules of CONSORT in a peer-reviewed journal or | |
| presentation using de-identified or non-identifiable information. Sensitive information | |
| including participants’ details will not be disclosed and will be treated | |
| strictly under the privacy and confidentiality act of Malaysia and Australia.</p> | |
| </sec> | |
| </sec> | |
| <sec sec-type="discussion" id="section33-15347354241252698"> | |
| <title>Discussion</title> | |
| <p>CRF is endemic in cancer survivors with disabling effects on quality of life, | |
| co-morbidities, independent living, and work productivity. It includes physiological | |
| changes associated with cancer diagnosis and treatment such as cortisol dysregulation, | |
| sleep disorders, depression, and functional disability, which further contribute to the | |
| burden of CRF. Despite the high incidence of CRF and its symptom clusters involving sleep | |
| quality and depression, there is no effective pharmacological intervention to prevent or | |
| alleviate these symptoms,<sup> | |
| <xref rid="bibr68-15347354241252698" ref-type="bibr">68</xref> | |
| </sup> | |
| highlighting the need to study CRF and its related symptom clusters to understand the | |
| common biological mechanisms to improve quality of life of cancer survivors. Numerous | |
| studies have reported certain psychological and physiological benefits of Qigong for | |
| cancer survivors, promising potential in the realm of cancer medicine. While its | |
| definitive impact requires further extensive research, some studies suggest benefits such | |
| as enhanced physical functioning, stress reduction, improved mental health, immune | |
| enhancement, and improved quality of life, and that it may complement conventional | |
| medicine as adjunct therapy by providing a holistic approach to cancer care.<sup><xref | |
| rid="bibr29-15347354241252698" ref-type="bibr">29</xref>,<xref | |
| rid="bibr33-15347354241252698" ref-type="bibr">33</xref> | |
| <xref | |
| rid="bibr34-15347354241252698" ref-type="bibr" /><xref rid="bibr35-15347354241252698" | |
| ref-type="bibr" /><xref rid="bibr36-15347354241252698" ref-type="bibr" /><xref | |
| rid="bibr37-15347354241252698" ref-type="bibr" /><xref rid="bibr38-15347354241252698" | |
| ref-type="bibr" /><xref rid="bibr39-15347354241252698" ref-type="bibr" /><xref | |
| rid="bibr40-15347354241252698" ref-type="bibr" /><xref rid="bibr41-15347354241252698" | |
| ref-type="bibr" /><xref rid="bibr42-15347354241252698" ref-type="bibr" /><xref | |
| rid="bibr43-15347354241252698" ref-type="bibr" />-<xref rid="bibr44-15347354241252698" | |
| ref-type="bibr">44</xref></sup> As research progresses, understanding its potential | |
| role in cancer medicine could open doors to more comprehensive and patient-centric | |
| approaches to healthcare. In this regard, GQ emerges as a unique mind-body exercise that | |
| combines moderate and adaptive walking exercise with a pronounced focus on a specialized | |
| breathing technique.<sup> | |
| <xref rid="bibr97-15347354241252698" ref-type="bibr">97</xref> | |
| </sup> While | |
| walking has been reported to improve cancer-related symptoms,<sup><xref | |
| rid="bibr57-15347354241252698" ref-type="bibr">57</xref> | |
| <xref | |
| rid="bibr58-15347354241252698" ref-type="bibr" /><xref rid="bibr59-15347354241252698" | |
| ref-type="bibr" />-<xref rid="bibr60-15347354241252698" ref-type="bibr">60</xref></sup> | |
| the incorporation of breathing technique of GQ serves to foster oxygen-carbon dioxide | |
| homeostasis—an essential factor in cancer control and ultimately survival.<sup><xref | |
| rid="bibr60-15347354241252698" ref-type="bibr">60</xref>,<xref | |
| rid="bibr61-15347354241252698" ref-type="bibr">61</xref></sup> As such GQ stands as a | |
| promising avenue for addressing the cluster of symptoms associated with CRF, encompassing | |
| sleep disorder, depression, and alterations in cortisol. However, despite this promising | |
| potential, the comprehensive exploration of GQ’s benefits remains a yet untapped | |
| opportunity.</p> | |
| <p>Therefore, our hypothesis posits that the current study of GQ is a feasible intervention | |
| that holds potential to ameliorate CRF, enhance sleep quality, alleviate depression, and | |
| regulate cortisol levels among breast, lung, and colon cancer survivors, while | |
| concurrently unveiling a comprehensive spectrum of benefits and barriers related to | |
| participation and adherence to GQ training, offering invaluable insights for optimizing | |
| and enriching the program.</p> | |
| <p>This is the first mixed-method study comprising a randomized-controlled trial and semi | |
| structured interview to evaluate the feasibility and benefits of GQ on CRF symptom cluster | |
| among cancer survivors. The quantitative data from the randomized-controlled trial | |
| complements the qualitative insights to be obtained through interviews, allowing for a | |
| comprehensive exploration of the subjective domains of feasibility, adherence, barriers | |
| and participants’ perceptions, experiences of GQ to help improve healthcare and | |
| identify factors for enhancing GQ intervention effectiveness.</p> | |
| <p>Moreover, the composition of this multidisciplinary study team comprising experts from | |
| Western Medicine and Chinese Medicine integrating their expertise from different | |
| perspectives will lead to robust study design, enhanced participant care, rigorous data | |
| analysis and comprehensive interpretation of results.</p> | |
| </sec> | |
| <sec id="section34-15347354241252698"> | |
| <title>Limitations</title> | |
| <p>The nature of the intervention precludes blinding of both participants and researcher. | |
| While the researcher remains unblinded as this trial is open-label, the instructors will | |
| not be aware of intervention allocation to minimize bias. Although including cancer | |
| survivors across all stages enables a diverse assessment of feasibility, it potentially | |
| limits the generalizability of the results though sub-group analysis will be conducted. | |
| Furthermore, the reliance on self-reported data for secondary outcomes emphasizes the | |
| necessity for incorporating objective measures like actigraphy, polysomnography, and | |
| established scales such as the Hamilton Depression Rating Scale to ensure a comprehensive | |
| evaluation of GQ’s impact on CRF, sleep quality, and depression. Additionally, the | |
| predominant participation of Asian Chinese individuals highlights the need for expanded | |
| research to comprehend GQ’s feasibility and effects among cancer survivors from | |
| various ethnic and racial backgrounds. These limitations underscore the challenges | |
| inherent in the study’s design and demographics, emphasizing the importance of | |
| integrating objective measures and broadening participant diversity for more conclusive | |
| and inclusive findings.</p> | |
| <p>Despite the limitations, exploring GQ as a potential intervention to address existing | |
| gaps in effective treatment for CRF and its related symptom cluster of sleep quality and | |
| depression in cancer survivors demonstrates a forward-thinking approach in the field of | |
| oncology. It expands on the knowledge base and promotes innovative thinking, fostering the | |
| development of novel interventions with potential contribution to the advancement of | |
| oncology care.</p> | |
| </sec> | |
| <sec sec-type="conclusions" id="section35-15347354241252698"> | |
| <title>Conclusion</title> | |
| <p>The insights gained from this study may guide future design and implementation of | |
| evidence based mind-body interventions to improve cancer survivorship.</p> | |
| </sec> | |
| <sec sec-type="supplementary-material" id="section36-15347354241252698" | |
| specific-use="figshare"> | |
| <title>Supplemental Material</title> | |
| <supplementary-material id="suppl1-15347354241252698" position="float" | |
| content-type="local-data"> | |
| <caption> | |
| <title>sj-docx-2-ict-10.1177_15347354241252698 – Supplemental material for | |
| Exploring Guolin Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in | |
| Cancer Survivors: A Mixed Method Randomized Controlled Trial Protocol</title> | |
| </caption> | |
| <media xlink:href="sj-docx-2-ict-10.1177_15347354241252698.docx" /> | |
| <p>Supplemental material, sj-docx-2-ict-10.1177_15347354241252698 for Exploring Guolin | |
| Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in Cancer Survivors: A | |
| Mixed Method Randomized Controlled Trial Protocol by Sara L. K. Low, Gwo Fuang Ho, | |
| Bingkai Liu, Eng-Siew Koh, Yutong Fei, Chiah Shean Teo and Xiaoshu Zhu in Integrative | |
| Cancer Therapies</p> | |
| </supplementary-material> | |
| <supplementary-material id="suppl2-15347354241252698" position="float" | |
| content-type="local-data"> | |
| <caption> | |
| <title>sj-docx-3-ict-10.1177_15347354241252698 – Supplemental material for | |
| Exploring Guolin Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in | |
| Cancer Survivors: A Mixed Method Randomized Controlled Trial Protocol</title> | |
| </caption> | |
| <media xlink:href="sj-docx-3-ict-10.1177_15347354241252698.docx" /> | |
| <p>Supplemental material, sj-docx-3-ict-10.1177_15347354241252698 for Exploring Guolin | |
| Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in Cancer Survivors: A | |
| Mixed Method Randomized Controlled Trial Protocol by Sara L. K. Low, Gwo Fuang Ho, | |
| Bingkai Liu, Eng-Siew Koh, Yutong Fei, Chiah Shean Teo and Xiaoshu Zhu in Integrative | |
| Cancer Therapies</p> | |
| </supplementary-material> | |
| <supplementary-material id="suppl3-15347354241252698" position="float" | |
| content-type="local-data"> | |
| <caption> | |
| <title>sj-docx-4-ict-10.1177_15347354241252698 – Supplemental material for | |
| Exploring Guolin Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in | |
| Cancer Survivors: A Mixed Method Randomized Controlled Trial Protocol</title> | |
| </caption> | |
| <media xlink:href="sj-docx-4-ict-10.1177_15347354241252698.docx" /> | |
| <p>Supplemental material, sj-docx-4-ict-10.1177_15347354241252698 for Exploring Guolin | |
| Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in Cancer Survivors: A | |
| Mixed Method Randomized Controlled Trial Protocol by Sara L. K. Low, Gwo Fuang Ho, | |
| Bingkai Liu, Eng-Siew Koh, Yutong Fei, Chiah Shean Teo and Xiaoshu Zhu in Integrative | |
| Cancer Therapies</p> | |
| </supplementary-material> | |
| <supplementary-material id="suppl4-15347354241252698" position="float" | |
| content-type="local-data"> | |
| <caption> | |
| <title>sj-pdf-1-ict-10.1177_15347354241252698 – Supplemental material for | |
| Exploring Guolin Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in | |
| Cancer Survivors: A Mixed Method Randomized Controlled Trial Protocol</title> | |
| </caption> | |
| <media xlink:href="sj-pdf-1-ict-10.1177_15347354241252698.pdf" /> | |
| <p>Supplemental material, sj-pdf-1-ict-10.1177_15347354241252698 for Exploring Guolin | |
| Qigong (Mind-Body Exercise) for Improving Cancer Related Fatigue in Cancer Survivors: A | |
| Mixed Method Randomized Controlled Trial Protocol by Sara L. K. Low, Gwo Fuang Ho, | |
| Bingkai Liu, Eng-Siew Koh, Yutong Fei, Chiah Shean Teo and Xiaoshu Zhu in Integrative | |
| Cancer Therapies</p> | |
| </supplementary-material> | |
| </sec> | |
| </body> | |
| <back> | |
| <ack> | |
| <p>We thank Cansurvive Centre Malaysia Berhad and Breast Cancer Women Association for their | |
| invaluable support in promoting the study through their membership base. We also wish to | |
| express our gratitude to the two Guolin Qigong instructors, Wong Wei Ming of Shah Alam | |
| Guolin Qigong Paradise, Selangor and Chan Lan Fong of Lake Garden Guolin Qigong, Kuala | |
| Lumpur for their unwavering passion and dedication in teaching participants throughout the | |
| duration of the program. Their commitment to the Guolin Qigong classes over most weekends | |
| exemplifies their exceptional dedication to the research study. We are also immensely | |
| thankful to the courageous and resilient cancer survivors who generously share their | |
| personal experiences of their journey to recovery, providing encouragement and hope to the | |
| study participants.</p> | |
| </ack> | |
| <fn-group> | |
| <fn fn-type="con"> | |
| <p><bold>Author Contributions:</bold> Conceptualization and design: Sara LK Low, Xiaoshu | |
| Zhu, Gwo Fuang Ho, BingKai Liu, Eng-Siew Koh, and Yutong Fei. Recruitment: Sara LK Low, | |
| Gwo Fuang Ho, Chiah Shean Teo. Investigating : Sara LK Low. Project Administration: Sara | |
| LK Low. Supervision: Xiaoshu Zhu, Gwo Fuang Ho, BingKai Liu, Eng-Siew Koh, and Yutong | |
| Fei. Writing- original draft: Sara LK Low. Writing-review and editing: Sara LK Low, Gwo | |
| Fuang Ho, BingKai Liu, Eng-Siew Koh, Chiah Shean Teo, Yutong Fei, Xiaoshu Zhu. All | |
| authors read and approved the final manuscript.</p> | |
| </fn> | |
| <fn fn-type="other"> | |
| <p><bold>Availability of Data and Materials:</bold> The datasets used and/or analyzed | |
| during the current study are available from the corresponding author on reasonable | |
| request.</p> | |
| </fn> | |
| <fn fn-type="other"> | |
| <p><bold>Consent for Publication:</bold> Consent for publication is not required as there | |
| is no details on individuals reported within the manuscript.</p> | |
| </fn> | |
| <fn fn-type="COI-statement"> | |
| <p>The author(s) declared no potential conflicts of interest with respect to the research, | |
| authorship, and/or publication of this article.</p> | |
| </fn> | |
| <fn fn-type="financial-disclosure"> | |
| <p><bold>Funding:</bold> The author(s) disclosed receipt of the following financial | |
| support for the research, authorship, and/or publication of this article: This paper is | |
| part of a PhD study and it is supported by the School of Health Science, Western Sydney | |
| University and Chinese Medicine Centre (an international collaboration between Western | |
| Sydney University and Beijing University of Chinese Medicine). Professor Xiaoshu Zhu and | |
| Professor Yutong Fei who are the supervisors of the first author of this manuscript are | |
| employed as academic by these institutes respectively.</p> | |
| </fn> | |
| <fn fn-type="other"> | |
| <p><bold>Trial Status:</bold> Recruitment of participants started on October 2022. The | |
| trial is currently underway and expected to be completed by end of 2025. The protocol is | |
| version no.3 dated 16 May 2022.</p> | |
| </fn> | |
| <fn fn-type="other"> | |
| <p><bold>Ethics Approval and Consent to Participate:</bold> This study has been approved | |
| by Medical Research Ethic Committee of University Malaya Medical Centre (MREC ID NO: | |
| 2022323-11092) and recognized by Western Sydney University Human Research Ethics | |
| Committee (RH15124). All methods will be conducted in accordance with the ethical | |
| standards of the declaration of Helsinki. Informed consent will be obtained from all | |
| subjects.</p> | |
| </fn> | |
| <fn fn-type="other"> | |
| <p><bold>ORCID iDs:</bold> Sara L. K. Low <inline-graphic | |
| xlink:href="10.1177_15347354241252698-img1.jpg" /> | |
| <ext-link | |
| xlink:href="https://orcid.org/0000-0001-6296-6052" ext-link-type="uri"> | |
| https://orcid.org/0000-0001-6296-6052</ext-link></p> | |
| <p>Chiah Shean Teo <inline-graphic xlink:href="10.1177_15347354241252698-img1.jpg" /> | |
| <ext-link | |
| xlink:href="https://orcid.org/0000-0003-1071-443X" ext-link-type="uri"> | |
| https://orcid.org/0000-0003-1071-443X</ext-link></p> | |
| <p>Xiaoshu Zhu <inline-graphic xlink:href="10.1177_15347354241252698-img1.jpg" /> | |
| <ext-link | |
| xlink:href="https://orcid.org/0000-0002-2909-5926" ext-link-type="uri"> | |
| https://orcid.org/0000-0002-2909-5926</ext-link></p> | |
| </fn> | |
| <fn fn-type="supplementary-material"> | |
| <p><bold>Supplemental Material:</bold> Supplemental material for this article is available | |
| online.</p> | |
| </fn> | |
| </fn-group> | |
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