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Recruitment, adherence, and retention of endometrial cancer survivors in a behavioural lifestyle programme: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomised pilot trial.

ABSTRACT: OBJECTIVE:Healthy eating and physical activity may help endometrial cancer survivors (ECS) improve their quality of life. However, most ECS do not meet the relevant guidelines. This pilot trial aimed to test the study feasibility procedures for a definitive trial of a behavioural lifestyle programme. DESIGN AND SETTING:This 24-week parallel two-arm randomised pilot trial took place in two hospitals in London, UK (April 2015-June 2016). PARTICIPANTS:Sixty disease-free ECS within 3 years of diagnosis. INTERVENTIONS:Participants were randomised using minimisation to receive the intervention or care as usual. The 'Shape-Up following cancer treatment' programme used self-monitoring, goal-setting, self-incentives, problem-solving and group social support for 12?hours over 8 weeks to help survivors improve their eating and physical activity. OUTCOME MEASURES:The main outcome measures were recruitment, adherence, and retention rates. Further outcomes included barriers to participation and feedback on programme satisfaction. RESULTS:Of the 296 potentially eligible ECS, 20% (n=60) were randomly allocated to the active intervention (n=29) or control group (n=31). Three participants in each arm were deemed ineligible after randomisation and excluded from analysis. Twenty participants (77%; 95%?CI 61% to 93%) adhered to the intervention and provided generally favourable feedback. At 24 weeks, 25/26 (96%; 95%?CI 89% to 100%) intervention and 24/28 (86%; 95%?CI 73% to 99%) control participants completed their assessment. No intervention-related adverse events were reported. Among eligible survivors who declined study participation (n=83), inconvenience (78%; 95%?CI 69% to 87%) was the most common barrier. CONCLUSIONS:The trial was feasible to deliver based on the a priori feasibility criteria. Enhancing recruitment and adherence in a definitive trial will require designs that promote convenience and consider ECS-reported barriers. TRIAL REGISTRATION NUMBER:NCT02433080; Pre-results. TRIAL FUNDING:University College London, St. Bartholomew's Hospital Nurses League, and NIHR University College London Hospitals Biomedical Research Centre.

SUBMITTER: Koutoukidis DA

PROVIDER: S-EPMC5640120 | biostudies-literature | 2017 Oct

REPOSITORIES: biostudies-literature

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Recruitment, adherence, and retention of endometrial cancer survivors in a behavioural lifestyle programme: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomised pilot trial.

Koutoukidis Dimitrios A DA Beeken Rebecca J RJ Manchanda Ranjit R Michalopoulou Moscho M Burnell Matthew M Knobf M Tish MT Lanceley Anne A

BMJ open 20171008 10

<h4>Objective</h4>Healthy eating and physical activity may help endometrial cancer survivors (ECS) improve their quality of life. However, most ECS do not meet the relevant guidelines. This pilot trial aimed to test the study feasibility procedures for a definitive trial of a behavioural lifestyle programme.<h4>Design and setting</h4>This 24-week parallel two-arm randomised pilot trial took place in two hospitals in London, UK (April 2015-June 2016).<h4>Participants</h4>Sixty disease-free ECS wi ...[more]

PMID: 28993394

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Project description:BackgroundOur data have indicated that minority breast cancer survivors are receptive to participating in lifestyle interventions delivered via email or the Web, yet few Web-based studies exist in this population.ObjectiveThe aim of this study was to examine the feasibility and preliminary results of an email-delivered diet and activity intervention program, "A Lifestyle Intervention Via Email (ALIVE)," delivered to a sample of racial and ethnic minority breast cancer survivors.MethodsSurvivors (mean age: 52 years, 83% [59/71] African American) were recruited and randomized to receive either the ALIVE program's 3-month physical activity track or its 3-month dietary track. The fully automated system provided tools for self-monitoring and goal setting, tailored content, and automated phone calls. Descriptive statistics and mixed-effects models were computed to examine the outcomes of the study.ResultsUpon completion, 44 of 71 survivors completed the study. Our "intention-to-treat" analysis revealed that participants in the physical activity track made greater improvements in moderate to vigorous activity than those in the dietary track (+97 vs. +49 min/week, P<.001). Similarly, reductions in total sedentary time among those in the physical activity track (-304 vs. -59 min/week, P<.001) was nearly 5 times greater than that for participants in the dietary track. Our completers case analysis indicated that participants in the dietary track made improvements in the intake of fiber (+4.4 g/day), fruits and vegetables (+1.0 cup equivalents/day), and reductions in saturated fat (-2.3 g/day) and trans fat (-0.3 g/day) (all P<.05). However, these improvements in dietary intake were not significantly different from the changes observed by participants in the physical activity track (all P>.05). Process evaluation data indicated that most survivors would recommend ALIVE to other cancer survivors (97%), were satisfied with ALIVE (82%), and felt that ALIVE was effective (73%). However, survivors expressed concerns about the functionality of the interactive emails.ConclusionsALIVE appears to be feasible for racial and ethnic minority cancer survivors and showed promising results for larger implementation. Although survivors favored the educational content, a mobile phone app and interactive emails that work on multiple email domains may help to boost adherence rates and to improve satisfaction with the Web-based platform.Trial registrationClinicalTrials.gov NCT02722850; https://clinicaltrials.gov/ct2/show/NCT02722850 (Archived by WebCite at http://www.webcitation.org/6tHN9VsPh).

Project description:ObjectivesTo identify studies that applied behavioural approaches to issues of recruitment and/or retention to trials; to describe these approaches; and to identify gaps for future research.DesignSystematic mapping review of research undertaken in clinical trials within peer-reviewed sources. Review participants were individuals involved in clinical trials, including trial staff, participants, potential participants and former participants.Data sourcesMEDLINE, EMBASE, CINAHL, ERIC, PsycINFO, Web of Science and ASSIA from inception to 15 January 2020 with no date or language restrictions.Eligibility criteriaStudies within the context of clinical trials reporting the barriers/facilitators to recruitment and retention, or developing/evaluating solutions to said barriers/facilitators, using a behavioural approach.Results31 articles were included. Recruitment-focused studies (n=22, 71%) represented the majority. Studies tended to focus on participant behaviours (n=22, 71%). Underserved populations (n=11, 35%) were a notable subset of studies. Most studies (n=23, 74%) were exploratory but those that evaluated interventions (n=8, 26%) often did so within underserved populations (n=6). A majority of studies (n=30, 97%) did not specify their behaviours consistent with guidelines from behavioural scientists. The most used approaches were social cognitive theory (n=8, 26%), the theory of planned behaviour (n=6, 19%) and the theoretical domains framework (n=5, 16%).ConclusionsA range of behavioural approaches have been applied to recruitment and retention to trials. The multitude of recruitment research here is consistent with trials research generally and emphasises the need for research into retention. Authors report target behaviours minimally, which is not conducive to replication. Further research should build on lessons here, such as clearly specifying behaviours. Increased methodological rigour and transparency will lead to robust evidence bases and less research waste in poor recruitment and retention. Overall, trials informed by behavioural approaches promises to be efficient and more participant focused.

Dataset Information

Recruitment, adherence, and retention of endometrial cancer survivors in a behavioural lifestyle programme: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomised pilot trial.

Publications

Recruitment, adherence, and retention of endometrial cancer survivors in a behavioural lifestyle programme: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomised pilot trial.

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