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Ethics approval and consent to participate | Ethical approval to conduct the study were obtained from Muhimbili University of Heath and Allied Sciences Senate Research and Publications Committee (Ref. No. 2015-10-27/AEC/Vol.X/54), National Health Research Ethics Committee (Ref. No. NIMRlHQ/R. SaJVol. 1X12144), Tanzania Medicines and Medical Devices Authority (Ref... | PMC9942299 | ||
Consent for publication | Consent to publish was obtained from National Health Research Ethics Committee (Ref. No. NIMRlHQ/R. SaJVol. 1X12144). | PMC9942299 | ||
Competing interests | Authors declare that they have no competing interests. | PMC9942299 | ||
References | PMC9942299 | |||
Background | lung cancer, cancer | LUNG CANCER, CANCER, AIDS | Shared decision-making (SDM), which increases the patient’s well-being, adherence, and success of treatment, is becoming increasingly important in medicine and especially in oncology. To empower patients to participate more actively in consultations with their physicians decision aids have been developed. In non-curati... | PMC10209551 |
Methods | The HELP-study is designed as a randomized, controlled, open monocenter trial with two parallel groups. The intervention consists of the use of the HELP decision aid brochure, accompanied by a decision coaching session. The primary endpoint is clarity of personal attitude as operationalized by the Decisional Conflict S... | PMC10209551 | ||
Discussion | lung) cancer | AIDS, BEST | Developing decision aids (DA) for (lung) cancer patients with limited prognosis should empower patients to address these aspects and include information about “Best Supportive Care” as a treatment option. Using and implementing the decision aid HELP can not only give patients the possibility to include their personal w... | PMC10209551 |
Trial registration | German Clinical Trial Register DRKS00028023. Registered on 8 February 2022. | PMC10209551 | ||
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10209551 | ||
Introduction | PMC10209551 | |||
Background and rationale {6a} | AIDS | Shared decision-making (SDM) is becoming increasingly important in medicine and especially in oncology [Decisions in the course of treatment are influenced by the doctor-patient relationship [To empower patients to participate more actively in consultations with their physicians, decision aids have been developed [ | PMC10209551 | |
Existing knowledge | cancer, Cancer | CANCER, DISEASE, CANCER | Patients wish more and more to participate in medical decision-making. This wish has increased steadily over the past 30 years. In 22 of the studies published from 2000 to 2012 on decision-making in cancer treatment, 85% of patients expressed a need to participate in medical decisions during their treatment process (vs... | PMC10209551 |
Need for a trial | lung cancer, cancer | LUNG CANCER, CANCER, AIDS | Decisions taken in non-curative settings differ substantially from those taken in curative settings, as uncertain gains in terms of survival outcomes and quality of life have to be weighed against severe side effects of treatment regimens. There is still a lack of tools developed and implemented for specific settings i... | PMC10209551 |
Objectives {7} | lung cancer, Depression, Anxiety | LUNG CANCER | The aim of HELP is to promote patient autonomy and competence and facilitate shared decision-making in the context of treatment decisions for lung cancer patients. Patients who had decision coaching with the decision aid HELP are expected to show more clarity in their personal attitude concerning the treatment decision... | PMC10209551 |
Trial design {8} | EVENT | The HELP-study is designed as a randomized, controlled, open monocenter, two-arm superiority trial with two parallel groups and a primary endpoint of “clarity of personal attitude” as operationalized by the Decisional Conflict Scale (DCS) which will be collected before the decision event. Following the assumptions that... | PMC10209551 | |
Methods: participants, interventions, and outcomes | PMC10209551 | |||
Study setting {9} | lung cancer | ONCOLOGY, THORACIC, METASTATIC LUNG CANCER, LUNG CANCER | HELP will be conducted at the Department of Thoracic Oncology, University Hospital Heidelberg, which is one of the largest lung cancer centers in Germany. Here, about 600 patients are newly diagnosed with metastatic lung cancer every year. | PMC10209551 |
Eligibility criteria {10} | lung cancer | LUNG CANCER, DISEASE PROGRESSION | The patients involved in the study are facing a treatment decision due to a newly diagnosed lung cancer or due to a disease progression.Inclusion criteria for patients:At least 18 years old;Able to give consent;Good German language skills;Diagnosis of incurable lung cancer (stage IV) and stage IIIb and IIIc; andWilling... | PMC10209551 |
Decision coaches | The decision coaches are nursing professionals and psychologists who are trained in decision support and play a supporting, but neutral role in the decision. As the training for decision coaches and the conversation guide are standardized, variations in the decision coaching conversations should be kept to a minimum. | PMC10209551 | ||
Physicians | To enable the integration of the decision aid in physician-patient consultations, a training course on the application of the decision aid in the context of everyday clinical practice at the Thoraxklinik Heidelberg was developed and conducted with the professionals involved in the decision-making process. In addition t... | PMC10209551 | ||
Who will gather informed consent? {26a} | Research Assistants will introduce the trial to patients with the help of an information sheet. Patients have the opportunity to discuss the trial with the research assistant and to ask questions, before the research assistant will obtain written consent from patients willing to participate in the trial. | PMC10209551 | ||
Additional consent provisions for collection and use of participant data and biological specimens {26b} | Not applicable as no ancillary studies will be conducted. | PMC10209551 | ||
Interventions | PMC10209551 | |||
Explanation for the choice of comparators {6b} | Patients may feel better prepared and thus more able to participate actively in decisions concerning their treatment when they get a decision coaching and/or decision aid before the consultation takes place. Therefore, usual care, i.e. standard consultation with the physician without decision aid and/or decision coachi... | PMC10209551 | ||
Intervention description {11a} | Eligible patients will be randomized in equal proportions between the intervention group (i.e., decision coaching with decision aid) and the control group (i.e., usual care/standard consultation) according to the characteristic of preferred decision-making at baseline (expressions: physician should decide; patient woul... | PMC10209551 | ||
Intervention group | The intervention consists of the use of the decision aid, accompanied by a decision coaching session. | PMC10209551 | ||
Decision aid | DISEASE | The decision aid HELP consists of a brochure for defining information and decision-making needs, including the patient’s personal values, as well as an overview of the most common forms of therapy. Both components are also available in digitalized form as a web app (htttps://awhelp.herokuappcom/#/).The brochure entitle... | PMC10209551 | |
Decision coaching | Depression, Anxiety | The coaching takes place in person or, if necessary, by telephone or online. The coaching process follows the sections of the HELP decision aid: patient’s information needs, the preferred method of decision-making, and the clarification of central personal values.After the coaching session and before the consultation w... | PMC10209551 | |
Control group | Depression, Anxiety | The participants in the control group get usual care, i.e., the doctor-patient conversation takes place without preliminary coaching and deliberation about their preferences and goals.Before the consultation with their physician, participants fill in the pre-survey questionnaires (Decisional Conflict Scale, Decision Se... | PMC10209551 | |
Criteria for discontinuing or modifying allocated interventions {11b} | status declines | Patients can leave the study at any time for any reason, without any consequences. If a patient’s health status declines and they are no longer able to answer the survey questions, they will be treated as a dropout. The same applies for participants who withdraw their consent for any other reason. Patient data collecte... | PMC10209551 | |
Strategies to improve adherence to interventions {11c} | The adherence to fill out the questionnaires before and after the conversation with the physician takes place is ensured by friendly reminders via phone call or mail. Intervention adherence, i.e., ensuring that patients show up for the arranged coaching session, is ensured by reminding patients via phone call one day a... | PMC10209551 | ||
Relevant concomitant care permitted or prohibited during the trial {11d} | As the intervention does not consist of any form of medical treatment, there are no restrictions concerning medical treatments. | PMC10209551 | ||
Provisions for post-trial care {30} | shortness | No provisions for ancillary and post-trial care will be provided, due to the absence of any physical intervention and the shortness of study. | PMC10209551 | |
Outcomes {12} | lung cancer | LUNG CANCER | The main objective is to investigate the effectiveness of the developed decision support and decision coaching for lung cancer patients. Effects will be measured by the sum score of the dimension “clarity of personal attitude” (items 4-6) of the Decisional Conflict Scale (DCS) [In addition, the effects of the HELP inte... | PMC10209551 |
Primary outcome | The primary outcome is the sum score of the dimension “clarity of personal attitude” in the Decisional Conflict Scale (DCS) after the decision coaching has taken place. The questionnaire is validated in German and shows good reliability [A clinically relevant difference of 10 points in the primary outcome between the t... | PMC10209551 | ||
Secondary outcomes | Secondary outcomes are the effects of the HELP intervention on patients’ self-efficacy, their perceived preparation for and involvement in treatment decision-making, and their emotional state. All questionnaires listed in Table Outcomes and instruments | PMC10209551 | ||
Participant timeline {13} | EVENTS | Participation in the study includes the completion of two questionnaires for each participant (before and after the medical consultation at intervals of 1–4 weeks). The questionnaires will be handed over personally (including a stamped return envelope) or sent by e-mail. The time needed to answer the questionnaires is ... | PMC10209551 | |
Sample size {14} | A clinically relevant difference of 10 points in the primary outcome between the two treatment groups was assumed to show a sufficient clinical difference for case planning. In addition, the standard deviation was estimated to be 20.6 from the literature [ | PMC10209551 | ||
Recruitment {15} | tumor | TUMOR, RECRUITMENT | Patients are identified by the recruiting research assistants in CT- and indication conferences and tumor board meetings and on oncological wards. If patients meeting the eligibility criteria are identified, recruitment takes place when the patients are in the clinic for their examination appointments like MRT, broncho... | PMC10209551 |
Assignment of interventions: allocation | PMC10209551 | |||
Sequence generation {16a} | Randomization to the two groups of the study (control and intervention group) will be performed in a ratio of 1:1. Stratified block randomization will be performed according to the characteristic of preferred decision-making at baseline (expressions: physician should decide; patient would like to decide alone; patient ... | PMC10209551 | ||
Concealment mechanism {16b} | Allocation concealment will be ensured by using opaque, sealed envelopes provided by the Institute of Medical Biometry, and takes place after the patients have been recruited. | PMC10209551 | ||
Implementation {16c} | After they have given written consent, participants are enrolled on the study. The recruiting research assistant opens the sealed envelopes and assigns patients to the intervention vs. control group according to the preferred decision-making style.Participants in the control group receive the questionnaires and are ins... | PMC10209551 | ||
Assignment of interventions: blinding | PMC10209551 | |||
Who will be blinded {17a} | Due to the design of the intervention, i.e., decision coaching with the decision aid, blinding is not possible, as the participants in the control group realize easily that they are not part of the intervention as they get no decision coaching and vice versa. | PMC10209551 | ||
Procedure for unblinding if needed {17b} | Since blinding is impossible (see above) there is no unblinding procedure. | PMC10209551 | ||
Data collection and management | PMC10209551 | |||
Plans for assessment and collection of outcomes {18a} | PMC10209551 | |||
Primary outcome | The For analysis, the authors recommend six sum scores: one for each of the five dimensions and one for an overall value. As the test construction assumes that the five subscales are predictors for the overall value, it is reasonable and in line with measurement theory to choose the subscale value clarity as the single... | PMC10209551 | ||
Secondary outcomes | The The Results on the concurrent validity of the German version PDMS-D correspond with previous international study findings [The In regard to construct validity, the subscales “patient activation by physicians” and “active information behavior of the patient” are highly correlated with satisfaction. The correlation o... | PMC10209551 | ||
Plans to promote participant retention and complete follow-up {18b} | Participants may withdraw from the study for any reason at any time. A drop-out rate of approximately 20% is expected. To keep drop-out at a minimal level, patients are reminded by a phone call to fill in the questionnaires and bring them to their next appointment. | PMC10209551 | ||
Data management {19} | The questionnaires will be checked for completeness and entered by qualified study personnel in the statistical analysis system. After data entry (according to the code book) a data quality check on plausibility will be performed. All questionnaires completed as part of the study will be digitized, archived at the Thor... | PMC10209551 | ||
Confidentiality {27} | Only investigators will have access to study-related patient information. Personal information and confidentiality of data entry, coding, security, and storage are in line with the German privacy protection law (Bundesdatenschutzgesetz, BDSG) [All questionnaires completed as part of the study will be digitized, archive... | PMC10209551 | ||
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | As there will be no biological specimens collected there are no plans for laboratory evaluation and/or storage. | PMC10209551 | ||
Statistical methods | PMC10209551 | |||
Statistical methods for primary and secondary outcomes {20a} | SECONDARY | A descriptive analysis of all collected patient information and data (as well as the scales that can be formed from the instruments) is performed: mean, standard deviation, median, minimum, and maximum, for continuous variables and absolute and relative frequencies for categorical variables.For all (primary and seconda... | PMC10209551 | |
Interim analyses {21b} | No interim analyses will be performed. | PMC10209551 | ||
Methods for additional analyses (e.g., subgroup analyses) {20b} | The adjustment for the variable of decision-making type (used in the stratified randomization) is already considered with the application of the van-Elteren-test in the primary analysis of the outcome. There are no subgroup analyses planned. | PMC10209551 | ||
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | PMC10209551 | |||
Analysis population | As analysis populations, the two common populations of intention-to-treat and per-protocol are defined and used. The intention-to-treat population considers all patients as randomized regardless of whether they finished the whole survey procedure. Criteria for determining the per-protocol population are as follows: pat... | PMC10209551 | ||
Missing data | Missing data might occur by patients’ withdrawal from trial, unreturned questionnaires after the consultation, or other circumstances. Reasons for withdrawal will be reported for each randomization group and compared qualitatively. The effect that any missing data might have on results will be assessed via sensitivity ... | PMC10209551 | ||
Plans to give access to the full protocol, participant level-data and statistical code {31c} | We are not able to provide data publicly due to the German data protection law and ethics approval regulations. Upon request, deidentified data can be shared, as can be the full protocol and statistical code. | PMC10209551 | ||
Oversight and monitoring | PMC10209551 | |||
Composition of the coordinating center and trial steering committee {5d} | RECRUITMENT | This is a monocenter study designed, performed, and coordinated in the oncology department of the Thoraxklinik Heidelberg. The following responsibilities can be defined in the research team:Principal investigator: overseeing study design and preparation of protocol incl. revisionsLead investigator: responsible for the ... | PMC10209551 | |
Composition of the data monitoring committee, its role and reporting structure {21a} | EMA | In accordance with EMA requirements, a Data Monitoring Committee is not needed as the study does not involve any medication, other medical treatment, or examinations such as blood samples, MRI, or X-ray examinations [ | PMC10209551 | |
Adverse event reporting and harms {22} | infection | INFECTION, DISEASE, BLOOD | Participation in the study does not entail any health risks apart from the risk of infection with COVID-19 in the case of a face-to-face conversation. Study participants can choose between face-to-face or contact via telephone or video (e.g., Jitsi) to avoid the risk of infection. For face-to-face interview appointment... | PMC10209551 |
Frequency and plans for auditing trial conduct {23} | shortness of the study | No auditing of trial conduct is intended due to the shortness of the study and the absence of any kind of medical intervention. | PMC10209551 | |
Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} | Any modifications to the protocol which may impact on the conduct of the study will require a formal amendment to the protocol. Modifications will have to be agreed upon by all members of the research team and approved by the Ethics Committee. | PMC10209551 | ||
Dissemination plans {31a} | cancer | CANCER | The results will be made available in peer-reviewed journals and presented at conferences. Both positive and negative results will be reported. In addition, a “corona-compliant” hybrid symposium will take place, at which the results of the study will be presented to experts and the general public and an exchange of inf... | PMC10209551 |
Discussion | lung cancer | LUNG CANCER | Deficits in SDM are still evident in oncology practice and are most challenging when treatment options are limited and new treatment options only show marginal benefits. These deficits may lead to patients choosing a paternalistic decision-making model. Thus, individual wishes, values, and preferences may be neglected.... | PMC10209551 |
Limitations | lung cancer, tumor | LUNG CANCER, DISEASE, TUMOR | Another intervention group — “decision aid only”, i.e., patients working with the decision aid by themselves, without coaching — would be desirable. With regard to the low possibility of recruiting an additional 89 patients in the given time, the idea of a second intervention group was dismissed.In the treatment of adv... | PMC10209551 |
Strengths | lung) cancer | BEST | Our DA for (lung) cancer patients with limited prognosis empowers patients to address “Best Supportive Care” as a treatment option during consultations with their physicians. Using and implementing the decision aid HELP can not only give patients the possibility to include their personal wishes and values in the decisi... | PMC10209551 |
Trial status | RECRUITMENT | Protocol version 1.0, 22.12.2021; First enrolment: 10.03.2022; recruitment will be completed bv approx. 31.01.2023. | PMC10209551 | |
Acknowledgements | BEST | We sincerely thank Theo Best for reviewing language and expression. | PMC10209551 | |
Authors’ contributions {31b} | All researchers involved in the study will be recognized through the granting of authorship: LU, ND, AS, and MV conceived the study and initiated the study design. MV is the principal investor. JK provided statistical expertise in clinical trial design and is conducting the primary statistical analysis together with LU... | PMC10209551 | ||
Funding {4} | Open Access funding enabled and organized by Projekt DEAL. Funding for this trial has been provided by the independent and non-profit Bristol Myers Squibb-Stiftung Immunonkologie (immune-oncology foundation), Munich. This funding source had no influence on the design of the study and will not have any role during its e... | PMC10209551 | ||
Availability of data and materials {29} | All investigators involved in the study will have full access to the data. Any data required to support the protocol can be supplied on request, as there are no contractual agreements limiting access for investigators. | PMC10209551 | ||
Declarations | PMC10209551 | |||
Ethics approval and consent to participate {24} | Ethical approval has been given by the Ethics Committee of the University Hospital Heidelberg (S977/2021). Written informed consent will be obtained from every participant. For patients, no harm is anticipated from the intervention. If any psychological harm is identified, referral to psycho-oncology services is possib... | PMC10209551 | ||
Consent for publication {32} | This manuscript does not contain individual personal data from patients. The participant information materials and informed consent form are available from the corresponding author on request. | PMC10209551 | ||
Competing interests {28} | The authors declare that they have no competing interests. | PMC10209551 | ||
References | PMC10209551 | |||
Background | alcohol dependence | Cue exposure therapy is used to treat alcohol dependence. However, its effectiveness is controversial due to the limitations of the clinical treatment setting. Virtual reality technology may improve the therapeutic effect. The aim of this study is to explore whether virtual reality-based cue exposure therapy can reduce... | PMC10726483 | |
Methods | alcohol-dependent | Forty-four male alcohol-dependent patients were recruited and divided into the study group (n = 23) and the control group (n = 21) according to a random number table. The control group received only conventional clinical treatment for alcohol dependence. The study group received conventional clinical treatment with the... | PMC10726483 | |
Results | After virtual reality-based cue exposure therapy, the changes in VAS and heart rate before and after cue exposure in the study group were significantly lower than those in the control group ( | PMC10726483 | ||
Conclusion | alcohol-dependent | Virtual reality-based cue exposure therapy can reduce the psychological craving and part of the physiological responses of alcohol-dependent patients during cue exposure in the short term and may be helpful in the treatment of alcohol dependence. | PMC10726483 | |
Trial registration | The study protocol was registered at the China Clinical Trial Registry on 26/02/2021 ( | PMC10726483 | ||
Keywords | PMC10726483 | |||
Introduction | chronic relapsing disorder, AD | Alcohol dependence (AD) is a complex chronic relapsing disorder, which refers to a special psychological state of craving for alcohol caused by long-term, repeated drinking, as well as a special psychological and physical responses to reducing or stopping drinking [ | PMC10726483 | |
Cue reactivity | AD | Numerous studies have demonstrated that AD patients exhibit a variety of psychological and physiological responses when exposed to alcohol-related cues, such as alcoholic beverages, alcohol-related environment, emotional factors, and social interactions, collectively referred to as cue reactivity. The observed changes ... | PMC10726483 | |
Cue exposure therapy | AD | Cue exposure therapy (CET) is a treatment method based on Pavlov’s theory of conditioning, in which AD patients are repeatedly exposed to alcohol-related cues and environments without exposure to alcohol, in order to reduce or even eliminate the conditioning between alcohol-related cues and psychophysiological response... | PMC10726483 | |
Virtual reality-based cue exposure therapy | AD | Virtual reality (VR) is a practical technology that combines virtualisation and reality to create a digital environment that is similar to the real environment [Although some studies have shown that VR-CET can reduce craving in AD patients, few studies have evaluated the changes in physiological responses in AD patient... | PMC10726483 | |
Methods | PMC10726483 | |||
Preliminary survey and construction of cues and scene | PMC10726483 | |||
Preliminary survey of cues and scene | AD | DISEASES, SAID | Due to the differences in drinking culture in different countries, it is first and foremost important to identify alcohol-related cues that can effectively induce the alcohol craving in Chinese AD patients and to construct the VR cue exposure scene that is suitable for the actual situation of Chinese AD patients.A semi... | PMC10726483 |
Construction of the VR cue exposure scene | PMC10726483 | |||
Actor selection | AD | Although the drinking patterns of social drinkers differ from those of AD patients, most AD patients develop from social drinking. We invited 5 social drinkers to participate in the shooting of the VR cue exposure | PMC10726483 | |
Site selection | We chose to shoot in a private room in a Chinese restaurant. The specific environmental requirements of the venue are as follows: ① the area of the private room is close to 15 square metres (4 m × 4 m); ② the round turntable table and chairs in the private room are placed in an orderly manner; ③ the lighting in the pri... | PMC10726483 | ||
Plot design | The plot is designed for 5 friends who have reunited after a long absence, having dinner in a private room in a restaurant. 5 people are seated around a circular table, upon which there are glasses, cutlery, white wine, beer, food and so on. In the course of the dinner, alcohol was persuaded for various reasons, such a... | PMC10726483 | ||
Instrument | The Insta360Pro2 panoramic camera from Insta360 Innovation Technology Co., Ltd. was used to shoot the VR cue exposure scene, and the video was processed and imported into the Oculus quest VR equipment manufactured by Oculus for playback. | PMC10726483 |
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