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

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.

The Association of Dietary Patterns with High-Risk Human Papillomavirus Infection and Cervical Cancer: A Cross-Sectional Study in Italy

“…Growing body of evidence suggests that dietary patterns might modulate the risk of female cancers [25,26], and several dietary intervention programs have been proposed to reduce cancer incidence and to improve health and quality of life [27][28][29]. However, to our knowledge, no previous studies evaluated the association between dietary patterns, hrHPV status and high grade CIN risk.…”

Phase II randomised control feasibility trial of a nutrition and physical activity intervention after radical prostatectomy for prostate cancer

“…Previous diet and physical activity interventions in cancer populations have reported higher adherence rates of around 70%. However, in these instances, the interventions were either less intensive or definitions of adherence were not as strict as the current study 25–27…”

Use of intervention mapping to adapt a health behavior change intervention for endometrial cancer survivors: the shape-up following cancer treatment program

“…The intervention has recently been evaluated within the DEUS (Diet and Exercise in Uterine Cancer Survivors) pilot trial in disease-free survivors within 3 years of diagnosis ( ClinicalTrials.gov identifier: NCT02433080) [ 33 , 34 ].…”