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3.1. Study Progress | RECRUITMENT | A total of 133 persons were screened for eligibility, of whom 61 were found eligible for recruitment (from November 2021 to January 2022) and were randomized into one of the four groups after their baseline visit (A total of 39 participants completed the trial, corresponding to a drop-out rate of 36% ( | PMC10096929 | |
3.2. Baseline Characteristics | As expected, randomization resulted in small differences between the four intervention groups except for energy intake and physical activity where some medians differed by factors between 1.5 and 2 ( | PMC10096929 | ||
3.3. Results of Intention-to-Treat Analyses | −7.3 | Fat mass was reduced by 1.3 kg (95% CI [−7.3, 10.0] kg; | PMC10096929 | |
3.4. Results of Complete-Case Analyses | Fat mass was reduced by 1.0 kg (95% CI [−0.6, 2.6] kg; | PMC10096929 | ||
3.5. Compliance | Overall, compliance was low to moderate. For the mindful eating group compliance declined over time: 100%, 89%, 44%, and 44%. For the YogaDance group, compliance fluctuated randomly across the 8-week intervention period: 100% (first week), 75%, 71%, 83%, 79%, 75%, 69%, and 71% (last week). Likewise, for the combined mi... | PMC10096929 | ||
4. Discussion | eating behavior, fat-free mass | SECONDARY, EVENT | Mindful eating and the combination of mindful eating and YogaDance showed more improvements than YogaDance alone. The estimated effect sizes were small, at most 0.11 and 0.35 in complete-case and intention-to-treat analyses, respectively, in any case far smaller than the anticipated effect size used for the sample size... | PMC10096929 |
5. Conclusions | eating behavior, overweight | OBESE | The study found a modest reduction in fat percent as well as modest improvements in quality of life and eating behavior. The practical implication is that the combination of mindful eating and YogaDance may be an accessible and feasible intervention for overweight and obese women. However, the study had low power to es... | PMC10096929 |
Supplementary Materials | The following supporting information can be downloaded at: Click here for additional data file. | PMC10096929 | ||
Author Contributions | Conceptualization, S.H.H. and A.Y.F.; methodology, S.H.H., A.Y.F., C.R. and F.M.; statistical analysis, C.R.; investigation, S.H.H. and A.Y.F.; resources, F.M.; data curation, S.H.H. and A.Y.F.; writing—original draft preparation, S.H.H. and A.Y.F.; writing—review and editing, S.H.H., A.Y.F., C.R. and F.M.; supervision... | PMC10096929 | ||
Institutional Review Board Statement | The study was conducted in accordance with the Declaration of Helsinki and approved by the Ethics Committee of the capital region of Denmark (in Danish: De Videnskabsetiske Komiteer for Region Hovedstaden) on 1 July 2021 with the protocol number H-21013705. Two additional protocol amendments were approved on 29 October... | PMC10096929 | ||
Informed Consent Statement | Informed consent was obtained from all participants involved in the study. | PMC10096929 | ||
Data Availability Statement | Raw data will be made available upon reasonable request. | PMC10096929 | ||
Conflicts of Interest | The authors declare no conflict of interest. | PMC10096929 | ||
Abbreviations | BMI = body mass index; BMD = bone mass density; BMI = body mass index; BW = body weight; CON = control; DBP = diastolic blood pressure; EI = energy intake; FFM = fat-free mass; FM = fat mass; HR max = maximum heart rate; IES-2 = Overall Intuitive Eating Scale-2 score (values in the interval 1–5); IQR = interquartile ra... | PMC10096929 | ||
References | FM | Flow chart of the study. CON = control, ME = mindful eating, YD = YogaDance, YDME = mindful eating and YogaDance combined.Baseline participant characteristics stratified according to intervention group.Data are shown as medians and interquartile ranges. BMD = bone mass density, BMI = body mass index, BW = body weight, ... | PMC10096929 | |
Background | weight increase, fatigue, mood disorders, breast cancer, Non-metastatic breast cancer, pain, sexual dysfunction, HR+) disease | RECURRENCE, ADVERSE DRUG REACTIONS, BREAST CANCER | Non-metastatic breast cancer treatment is mainly based on surgery, with or without chemotherapy, radiotherapy and/or hormone therapy. To reduce the risk of hormone receptor positive (HR+) disease recurrence, hormone therapy is prescribed for at least 5 years. It may induce adverse drug reactions (ADRs) as joint pain, s... | PMC10413707 |
Methods | anxiety, Pain, breast cancer, pain, depression, Depression | BREAST CANCER | The WEBAPPAC trial is a randomized, open-label, prospective, single-center phase 3 study aiming to assess the interest of a web-application support as compared to standard management among breast cancer patients initiating hormone therapy. The main endpoint is the proportion of patients with hormone therapy adherence f... | PMC10413707 |
Discussion | breast cancer | DISEASE, RECURRENCE, BREAST CANCER | Hormone therapy discontinuation or adherence failure in breast cancer patients may be indirectly related to an increased risk of recurrence. A better control of medication adherence, through the detection of side effects and some proposed actions trying to reduce them, appears therefore essential to limit the risk of d... | PMC10413707 |
Trial registration | NCT04554927, registered September 18, 2020. | PMC10413707 | ||
Protocol version | Version 2.1 dated from December 21, 2021. | PMC10413707 | ||
Keywords | PMC10413707 | |||
Background | PMC10413707 | |||
Breast cancer, hormone therapy, adverse effects and adherence | breast cancer, Hormone-dependent breast cancer, cancer, pain, anti-Aromatase/GnRH, tumors | RECURRENCE, BREAST CANCER, CANCER, TUMORS, ADVERSE DRUG REACTIONS | With 58,459 new cases yearly in France, breast cancer remains the most common cancer in women [Hormone-dependent breast cancer can relapse long after treatment has ended. Approximately 80% of patients have hormone receptor-positive (HR+) tumors [To reduce the risk of recurrence in women with HR + breast cancer, hormone... | PMC10413707 |
Cancer survivorship care plan | Adjuvant hormone therapy occurs at the end of a very supervised and reassuring hospital care, which leaves some patients with a feeling of being abandoned [SCP includes, at the medical level, a consultation with the oncologist and the breast nurse about 15 days after the end of radiotherapy, during which hormone therap... | PMC10413707 | ||
Telemedicine and mHealth | METASTATIC CANCER | To go further with such personalized follow-up outside the hospital, mobile health offers new perspectives for allowing patients to take a more active role in their care and improving monitoring of ADRs. According to the World Health Organization (WHO), mobile health includes “medical and public health practices that r... | PMC10413707 | |
The WEBAPPAC web-application | ADRs, breast cancer | EVENT, BREAST CANCER | Based on all these encouraging results of mobile health in patients monitoring, we proposed to implement a dedicated web-application for patients initiating adjuvant hormone therapy for breast cancer and to assess its benefits, notably on medication adherence and quality of life. The WEBAPPAC web-application has been d... | PMC10413707 |
Methods / Design | breast cancer | BREAST CANCER | The WEBAPPAC study is a randomized, open-label, prospective, single-center phase 3 trial aiming to compare the adherence to adjuvant hormone therapy at 18 months between breast cancer patients with the WEBAPPAC web-application support versus standard management. The WEBAPPAC protocol and this manuscript have been writt... | PMC10413707 |
Primary outcome | adherence failure of hormone therapy, failure of hormone therapy, breast cancer | BREAST CANCER | The main objective is to evaluate the benefit of the WEBAPPAC web-application on patient adherence to adjuvant hormone therapy for breast cancer 18 months after treatment start.The primary endpoint of the study is the proportion of patients with adherence failure of hormone therapy within 18 months after treatment star... | PMC10413707 |
Secondary outcomes | depression, forgetfulness, Anxiety, Pain | SECONDARY | The secondary objectives are to compare between patients with the web-application support and patients with standard support:
The rate of adherence failure of adjuvant hormone therapy at 6 months, defined similarly as for primary endpoint.The adherence rate to adjuvant hormone therapy at 6 and 18 months, according to t... | PMC10413707 |
Study population | psychiatric, years• Breast cancer, breast cancer | BREAST CANCER | The WEBAPPAC study addresses breast cancer patient candidates to initiate an adjuvant hormone therapy. Eligibility criteria are presented in Table
Eligibility criteria in the WEBAPPAC study• Patient aged ≥ 18 years• Breast cancer patient candidate for adjuvant hormone therapy• Proficiency in French language• Patient w... | PMC10413707 |
Study site | cancer | CANCER | The study is conducted in the comprehensive cancer centre François Baclesse, as indicated on | PMC10413707 |
Study experimental plan | The study will be proposed by breast nurses or physician oncologists to patients who meet the eligibility criteria. An explanation of the study and an information note will be given to them. Patients will be enrolled in the study once provided their written informed consent. Then, the randomization will be performed on... | PMC10413707 | ||
Modalities of participation | All enrolled patients will be given an adherence notebook and be instructed to complete it as well as asked to bring her hormone therapy prescription to each visit to the Center. | PMC10413707 | ||
Control arm: standard support only | During the end of active treatment consultation, the oncologist will prescribe the adjuvant hormone therapy treatment in accordance with multidisciplinary team decision and patient.The SCP will be then given to the patient, presented as a personalized follow-up and medical monitoring program alternating with her genera... | PMC10413707 | ||
Experimental arm: standard support plus WEBAPPAC web-application | pain, fatigue, anxiety | Patients randomized in the experimental arm will receive information in the same way as patients in the standard arm, and will be planned the same number of appointments at the center.The web-application will be installed on the patients’ smartphone after randomization, and links to install it on other devices will be ... | PMC10413707 | |
Assessment tools | PMC10413707 | |||
Adherence to hormone therapy | Initially developed for patients undergoing antihypertensive treatment, the Morisky Medication Adherence Scale-8 is widely used to assess adherence to oral treatments, particularly hormone therapy. The MMAS-8 is the most recent version of the questionnaire developed by the Morisky team [The total score ranges from 0 to... | PMC10413707 | ||
Quality of life | nausea, headaches, fatigue, anxiety, cancer, vomiting, pain, painful arm, increase, hair loss, cancer symptoms, breast symptoms, Cancer | TREATMENT SIDE EFFECTS, CANCER, DISEASE, LOSS OF APPETITE, HAIR LOSS, SKIN CONDITION, ADVERSE DRUG REACTIONS, CANCER | Quality of life will be assessed using the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 (Quality of Life Questionnaire-Core 30 items) self-administered questionnaire exploring general dimensions of quality of life (30 items) [The EORTC QLQ-C30 questionnaire measures functional status (phys... | PMC10413707 |
Anxiety/depression | depression, Depression, anxiety | The patients’ anxiety and depression levels will be assessed using the “Hospital and Depression Scale (HADS)” [ | PMC10413707 | |
Pain | Pain, pain | Assessment of pain intensity will be based on the use of the Visual Analogue Scale (VAS), widely used in clinical routine. Furthermore, pain and its impact on the patient’s daily life will be assessed using the French validated form of the Brief Pain Inventory (BPI) [The user experience with the WEBAPPAC web-applicatio... | PMC10413707 | |
Statistical design overview | PMC10413707 | |||
Sample size determination | In literature, discontinuation of adjuvant hormone therapy is reported in 20% of cases. The option of offering patients a web-application rather than an accompaniment by a standard follow-up would appear relevant if it allows to observe a difference in discontinuation rate of at least 10%. According to a two proportion... | PMC10413707 | ||
Statistical analyses | SECONDARY | Exploratory analyses of the data will provide, for quantitative variables, the mean, standard deviation, median, quartiles, and number of missing values; for qualitative variables, we will calculate the frequencies and their 95% confidence intervals. The demographic and clinical characteristics of the patients will be ... | PMC10413707 | |
Data management | A Web Based Data Capture (WBDC) system will be used for data collection and query handling. The investigator will ensure that data are recorded on the eCRFs as specified in the study protocol and in accordance with the instructions provided.The investigator ensures the accuracy, completeness, and timeliness of the data... | PMC10413707 | ||
Withdrawal from study | The reasons for why a patient may discontinue to participate to the study include the following circumstances:
Patient’s decision (the data already collected during the search can be kept and exploited unless the patient opposes it).Need to initiate another anti-tumor treatment than hormone therapy.Patient lost to view... | PMC10413707 | ||
Acknowledgements | Gilles, Cancer | CANCER | We are grateful to all the patients and their caregivers. The Northwest Data Center (CTD-CNO) is acknowledged for managing the data. It is supported by grants from the French National League Against Cancer (LNC) and the French National Cancer Institute (INCa). Gilles GIRAULT is thanked for his assistance for cited refe... | PMC10413707 |
Author contributions | FG, JMG, CD, MF, CO, AF, JL and BC devised the study concept and design. JL was responsible for overseeing the statistical section. FG, JMG, JL and BC have been involved in drafting the manuscript or revising it critically for important intellectual content. FG and BC supervised the entire work. All authors (FG, JMG, C... | PMC10413707 | ||
Funding | This trial (NCT04554927) is granted in the context of the call for projects 2018 « Performance research program » from the French Health Care System (grant number: PREPS-18-0534). In the context of this major external funding, the study protocol has undergone peer-review by the funding body. The funding agency is not i... | PMC10413707 | ||
Data Availability | Not applicable. | PMC10413707 | ||
Declarations | PMC10413707 | |||
Competing interests | The authors declare no competing interests. | PMC10413707 | ||
Ethics approval and consent to participate | This study has received ethical approval from the | PMC10413707 | ||
Consent for publication | Not applicable. | PMC10413707 | ||
Abbreviations | Depression, Anxiety, Pain | Adverse Drug ReactionsAromatase inhibitorsAgence Nationale d’Appui à la Performance / French Performance Support AgencyAmerican Society of Clinical OncologyBrief Pain InventoryData Processing Centerelectronic Case Report FormEuropean Organization for Research and Treatment of CancerEuropean Society for Medical Oncology... | PMC10413707 | |
References | PMC10413707 | |||
Background | DISORDER | Co-use of stimulants and opioids is rapidly increasing. Randomized clinical trials (RCTs) have established the efficacy of medications for opioid use disorder (MOUD), but stimulant use may decrease the likelihood of initiating MOUD treatment. Furthermore, trial participants may not represent “real-world” populations wh... | PMC9930351 | |
Methods | depression, OUD | REGRESSION | We conducted a two-stage analysis. First, associations between stimulant use (time-varying urine drug screens for cocaine, methamphetamine, or amphetamines) and initiation of buprenorphine or extended-release naltrexone (XR-NTX) were estimated across two RCTs (CTN-0051 X:BOT and CTN-0067 CHOICES) using adjusted Cox reg... | PMC9930351 |
Results | Analyses included 673 clinical trial participants, 139 NSDUH respondents (weighted to represent 661,650 people), 71,751 TEDS treatment episodes, and 1,933 ROI participants. The majority were aged 30–49 years, male, and non-Hispanic White. In RCTs, stimulant use reduced the likelihood of MOUD initiation by 32% (adjusted... | PMC9930351 | ||
Conclusions | OUD | Stimulant use is a barrier to buprenorphine or XR-NTX initiation in clinical trials and real-world populations that would benefit from OUD treatment. Interventions to address stimulant use among patients with OUD are urgently needed, especially among rural people injecting drugs, who already suffer from limited access ... | PMC9930351 | |
Supplementary Information | The online version contains supplementary material available at 10.1186/s13722-023-00364-3. | PMC9930351 | ||
Keywords | PMC9930351 | |||
Introduction | OUD | DISORDER, SECONDARY, ABUSE | Concomitant use of opioids and stimulants, primarily methamphetamine and cocaine, increased by over 80% in the past decade [However, concomitant stimulant use may reduce rates of MOUD initiation [Randomized clinical trials (RCTs) typically collect extensive covariate data that investigators can use to better control bi... | PMC9930351 |
Methods | PMC9930351 | |||
Data sources and populations | OUD | The source (or study) population for our analyses was the pooled study sample of participants in two multisite CTN treatment trials: 0051 (X:BOT [We defined three target populations for our analyses. The first is a nationally-representative sample of civilian, housed, noninstitutionalized adults with OUD identifying th... | PMC9930351 | |
Exposure, outcome, and covariates | depression, Depression, DSM-5 | DISORDERS | The primary exposure of interest, stimulant use, was defined according to UDS positivity for MA, other amphetamines, or cocaine in clinical trial data. UDS were collected with an FDA-approved one-step temperature-sensitive test cup; a further validity check was performed using a commercially available adulterant test s... | PMC9930351 |
Statistical analyses | PMC9930351 | |||
Creation of a selection diagram | Prior to analyses, a causal “selection diagram” (Additional
file | PMC9930351 | ||
Stage 1: estimation of stimulant use associations in the clinical trials | depression, opioid overdose deaths | DISORDER | Among participants in the clinical trials, cumulative incidences of MOUD initiation by baseline stimulant use were described using Kaplan–Meier curves. Cox proportional hazards models were used to estimate associations between time-varying stimulant use and initiation on MOUD. Analyses controlled for CTN trial (X:BOT v... | PMC9930351 |
Results | PMC9930351 | |||
Characteristics of RCT versus real-world target populations | This analysis included 673 clinical trial participants (n = 570 X:BOT and n = 103 CHOICES), 139 NSDUH respondents (weighted to represent 661,650 people), 71,751 TEDS treatment episodes, and 1933 ROI participants. Table | PMC9930351 | ||
Rates of stimulant use and treatment initiation or engagement | TEDS | All individuals in the CTN studies had access to and were expected to initiate buprenorphine or XR-NTX as part of their study participation. A total of 80% of participants initiated MOUD during the trials (543/673). Rates were higher in X:BOT (83%) than CHOICES (68%), explained by their inpatient vs. outpatient treatme... | PMC9930351 | |
Stage 1: associations between stimulant use and MOUD initiation in the clinical trials | MOUD | DISORDER | Figure
Cumulative incidence of medication for opioid use disorder (MOUD) initiation by baseline stimulant use overall and stratified by CTN study (N = 673; n = 570 X:BOT and n = 103 CHOICES) | PMC9930351 |
Discussion | SUDs, OUD | DISORDER, DISORDERS | Our study suggests that stimulant use is a barrier to buprenorphine or XR-NTX initiation. Whether associations were estimated in randomized trials or generalized to people needing SUD treatment, people entering SUD treatment, or people from rural communities with high rates of IDU, concurrent stimulant use was associat... | PMC9930351 |
Conclusion | polysubstance, OUD | This study emphasizes the negative impact that stimulant use may have on MOUD initiation in trials and extrapolates findings to three real-world populations needing OUD treatment, where polysubstance use is the norm rather than the exception. Although broadening the availability of MOUD is expected to improve the publi... | PMC9930351 | |
Acknowledgements | The authors would like to thank the many research staff and participants involved in CHOICES, X:BOT, the ROI, and the NSDUH for making this work possible. | PMC9930351 | ||
Author contributions | CF | RC conceptualized the study, performed data analysis, wrote the manuscript, and provided overall supervision and oversight for the project. CF performed data analysis. TK collected ROI and CHOICES data. OA, KH, and TK conceptualized the study and provided expertise on technical and addiction science-related issues. KR,... | PMC9930351 | |
Funding | ARC | X:BOT and CHOICES were supported by the NIDA CTN, NIH/NIDA UG1DA013035. The ROI is supported by UG3DA044829/UH3DA044829, UG3DA044798/UH3DA044798, UG3DA044830/UH3DA044830, UG3DA044823/UH3DA044823, UH3DA044822/UH3DA044822, UG3DA044831/UH3DA044831, UG3DA044825, UG3DA044826/UH3DA044826, U24DA044801, and UL1TR002369 co-fund... | PMC9930351 | |
Availability of data and materials | CTN 0051 X:BOT data are publicly available on the NIDA datashare website ( | PMC9930351 | ||
Declarations | PMC9930351 | |||
Ethics approval and consent to participate | ABUSE | All included studies were conducted with ethical approval and all included participants provided informed consent prior to participation. CHOICES was approved by the Advarra Institutional Review Board (IRB00000971), with participating sites deferring to its regulatory role, while each site in X:BOT and the ROI received... | PMC9930351 | |
Consent for publication | Not applicable. | PMC9930351 | ||
Competing interests | The authors declare that they have no competing interests. | PMC9930351 | ||
References | PMC9930351 | |||
Introduction | The present study aimed to determine the impact of vitamin D supplementation (VDs) on recovery delay among COVID-19 patients. | PMC9940050 | ||
Methods | CORONAVIRUS, MAY, SEVERE ACUTE RESPIRATORY SYNDROME | We performed a randomized controlled clinical trial at the national COVID-19 containment center in Monastir (Tunisia), from May to August 2020. Simple randomization was done in a 1:1 allocation ratio. We included patients aged more than 18 years who had confirmed reverse transcription-polymerase chain reaction (RT-PCR)... | PMC9940050 | |
Results | A total of 117 patients were enrolled. The mean age was 42.7 years (SD 14). Males represented 55.6%. The median duration of viral RNA conversion was 37 days (95% confidence interval (CI): 29–45.50) in the intervention group and 28 days (95% CI: 23–39) in the placebo group ( | PMC9940050 | ||
Conclusion | VDs was not associated with a shortened recovery delay when given to patients for whom the RT-PCR remained positive on the 14th day. | PMC9940050 | ||
Trial registration
| MAY | This study was approved by the Human Subjects Protection Tunisia center (TN2020-NAT-INS-40) on April 28, 2020, and by ClinicalTrial.gov on May 12, 2021 with approval number ClinicalTrials.gov ID: | PMC9940050 | |
Keywords | PMC9940050 | |||
Introduction
| respiratory infectious disease | CORONAVIRUS, CORONAVIRUS DISEASE 2019, SEVERE ACUTE RESPIRATORY SYNDROME | Coronavirus disease 2019 (COVID-19) represents an emerging respiratory infectious disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) [ | PMC9940050 |
Methods | The present manuscript was conducted according to the guidelines of the Consolidated Standards of Reporting Trials (CONSORTChecklist2010) [ | PMC9940050 | ||
Trial design | We performed a randomized controlled, parallel-group, blinded, clinical trial. | PMC9940050 | ||
Participants | We included patients older than 18 years who had confirmed COVID-19, with a positive RT-PCR, and for whom the RT-PCR remained positive on the 14th day. Participants were consecutively recruited according to laboratory results (COVID-19 positive on the 14th day). We did not include pregnant women and patients who refuse... | PMC9940050 | ||
Settings and location | COVID-19 INFECTION, MAY, INFECTIOUS DISEASE, CORONAVIRUS, SEVERE ACUTE RESPIRATORY SYNDROME | Intervention and data collection were performed in the national center for COVID-19 confinement. From May to August 2020, this center included all Tunisian patients having COVID-19.At the beginning of the COVID-19 epidemic in Tunisia and to limit the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2... | PMC9940050 | |
Intervention | MAY, GROUP B | The intervention started on May and finished on August 2020. Intervention was made by medical residents. Participants were randomized into two groups (Group A and Group B). The intervention group (Group A) received VDs (200,000 IU/1 ml of cholecalciferol (1 ml) oral form), while the control group (Group B) received a p... | PMC9940050 | |
Outcomes | Our primary outcome measure was the recovery delay defined as the period between the day of the 14th RT-PCR-positive result and the day of the second successive negative RT-PCR test result. Secondary outcomes included the monitoring for the SARS-CoV-2 RT-PCR cycle threshold (Ct) values from the date of randomization un... | PMC9940050 | ||
Sample size | Sample size was calculated using Package “Medcalc” (trial version). It was estimated in this survival analysis as 118 patients (59 patients in each group). We considered 80% power, alpha = 0.05, and recovery rate at 21 days of intervention: in group 1, 84%; in group 2, 60% [ | PMC9940050 | ||
Randomization | Microsoft Excel was used to generate the random allocation sequence [ | PMC9940050 | ||
Blinding | Patients, medical residents, laboratory technicians, and the intervention supervisors were blinded. The groups were labeled as A and B. | PMC9940050 | ||
Statistical methods | Data analysis was performed using SPSS Statistics software (SPSS) version 21.0. Statistical analysis was performed using intention-to-treat (ITT) analysis. The Kolmogorov–Smirnov test was used to verify the normal distribution of continuous variables. The mean ± standard deviation (SD) was used to describe the normally... | PMC9940050 |
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