ObjectiveHealthy 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 settingThis 24-week parallel two-arm randomised pilot trial took place in two hospitals in London, UK (April 2015–June 2016).ParticipantsSixty disease-free ECS within 3 years of diagnosis.InterventionsParticipants 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 measuresThe main outcome measures were recruitment, adherence, and retention rates. Further outcomes included barriers to participation and feedback on programme satisfaction.ResultsOf 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.ConclusionsThe 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 numberNCT02433080; Pre-results.Trial fundingUniversity College London, St. Bartholomew’s Hospital Nurses League, and NIHR University College London Hospitals Biomedical Research Centre.
People with serious mental illness (SMI) have identified barriers to engaging in behavioral weight management interventions (BWMIs). We assessed whether BWMIs that addressed these barriers were more effective. First, we systematically reviewed qualitative literature and used a thematic analysis to identify the characteristics of BWMIs that promote engagement for adults with SMI. Second, we systematically reviewed randomized controlled trials (RCTs) of BWMIs in adults with SMI. Data on the characteristics that promoted engagement and weight outcomes were extracted. We then used a crisp-set qualitative comparative analysis (CsQCA) to identify which characteristics were associated with weight loss. For the qualitative review, 20 studies in 515 people with SMI were analyzed and nine characteristics were reported to promote engagement in BWMIs. For the systematic review, 34 RCTs testing 36 interventions in 4305 participants were included. The active interventions resulted in more weight loss (mean = À4.37 to +1 kg at 6 weeks to 18 months follow-up) compared with controls (À1.64 to +3.08 kg). The CsQCA showed BWMIs that offered regular contact, tools to support enactment, and tailored materials were associated with effectiveness. As these are all supplementary strategies, it may be possible to augment BWMIs available for the general population to engage people with SMI.
ObjectivesTo explore the effectiveness of a theory-based behavioral lifestyle intervention on health behaviors and quality of life in endometrial cancer survivors.’MethodsThis was a secondary analysis of a randomized controlled pilot trial conducted in two UK hospitals enrolling disease-free stage I-IVA endometrial cancer survivors. Participants were allocated to an 8-week group-based healthy eating and physical activity intervention or usual care using 1:1 minimization. Participants were followed up at 8 and 24 weeks, with the 8-week assessment being blinded. Diet, physical activity, and quality of life were measured with the Alternative Healthy Eating Index 2010, Stanford 7-Day Physical Activity Recall, and the EORTC Quality of life Questionnaire Core 30, respectively. We analyzed all eligible participants using the intention-to-treat approach in complete cases, adjusting for baseline values, body mass index, and age.ResultsWe enrolled 60 of the 296 potentially eligible endometrial cancer survivors (May - December 2015). Fifty-four eligible participants were randomized to the intervention (n=29) or usual care (n=31), and 49 had complete follow-up data (n=24 in the intervention and n= 25 in usual care). Intervention adherence was 77%. At 8 weeks, participants in the intervention improved their diet compared to usual care (difference in Alternative Healthy Eating Index 2010 score 7.5 (95% CI: 0.1 to 14.9), P=0.046) but not their physical activity (0.1 metabolic equivalent-h/day 95% CI: (-1.6 to 1.8), P=0.879), or global quality of life score (5.0 (95% CI: -3.4 to 13.3), P=0.236). Global quality of life improved in intervention participants at 24 weeks (difference 8.9 (95% CI: 0.9 to 16.8), P=0.029). No intervention-related adverse events were reported.ConclusionsThe potential effectiveness of the intervention appeared promising. A future fully-powered study is needed to confirm these findings.Trial registration numberNCT02433080.
scite is a Brooklyn-based organization that helps researchers better discover and understand research articles through Smart Citations–citations that display the context of the citation and describe whether the article provides supporting or contrasting evidence. scite is used by students and researchers from around the world and is funded in part by the National Science Foundation and the National Institute on Drug Abuse of the National Institutes of Health.
hi@scite.ai
10624 S. Eastern Ave., Ste. A-614
Henderson, NV 89052, USA
Copyright © 2024 scite LLC. All rights reserved.
Made with 💙 for researchers
Part of the Research Solutions Family.