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Diet, physical activity, and health-related outcomes of endometrial cancer survivors in a behavioral lifestyle program: the Diet and Exercise in Uterine Cancer Survivors (DEUS) parallel randomized controlled pilot trial
  1. Dimitrios A Koutoukidis1,2,3,
  2. Rebecca J Beeken4,5,
  3. Ranjit Manchanda6,7,
  4. Matthew Burnell1,
  5. Nida Ziauddeen8,9,
  6. Moscho Michalopoulou1,4,
  7. M Tish Knobf1,10 and
  8. Anne Lanceley1
  1. 1 Department of Women’s Cancer, EGA Institute for Women’s Health, University College London, London, UK
  2. 2 Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
  3. 3 NIHR Oxford Biomedical Research Centre, Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom
  4. 4 Department of Behavioural Science and Health, University College London, London, UK
  5. 5 Leeds Institute of Health Sciences, University of Leeds, Leeds, UK
  6. 6 Department of Gynaecological Oncology, Barts Health NHS Trust, Royal London Hospital, London, UK
  7. 7 Barts Cancer Institute, Queen Mary University of London, London, UK
  8. 8 MRC Human Nutrition Research, Elsie Widdowson Laboratory, University of Cambridge, Cambridge, UK
  9. 9 Academic Unit of Primary Care and Population Sciences, University of Southampton, Southampton, UK
  10. 10 Acute Care/Health Systems Division, Yale University School of Nursing, West Haven, Connecticut, USA
  1. Correspondence to Anne Lanceley, Department of Women's Cancer, EGA Institute for Women's Health, University College London, London WC1E 6AU, UK; a.lanceley{at}ucl.ac.uk

Abstract

Objectives To explore the effectiveness of a theory-based behavioral lifestyle intervention on health behaviors and quality of life in endometrial cancer survivors.’

Methods This 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.

Results We 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.

Conclusions The potential effectiveness of the intervention appeared promising. A future fully-powered study is needed to confirm these findings.

Trial registration number NCT02433080.

  • endometrial cancer
  • healthy eating
  • physical activity
  • quality of life
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Footnotes

  • Contributors The authors’ contributions were as follows. AL and MTK conceived the study and were the grant holders. AL and RM were the site investigators for University College London Hospitals and Barts Health, respectively. DAK, AL, RJB, and MTK initiated the study design, and RM helped with protocol development and implementation. DAK and MM recruited the study participants. RJB was responsible for randomization and auditing. DAK was the trial manager, ran the group sessions, and conducted the baseline and 24-week follow-up assessments. MM conducted the 8-week follow-up assessments. NZ guided the dietary data analysis and checked entries for accuracy. MB provided the statistical support, and DAK conducted the statistical analysis. DAK drafted the manuscript, which was amended following comments from all other authors. All authors read and approved the submitted manuscript. All listed authors meet the criteria for authorship and no individual meeting these criteria has been omitted.

  • Funding Completion of this project was funded by the UCL Grand Challenges Scheme (514959.100.156741), the St. Bartholomew’s Hospital Nurses League, the Department of Women’s Cancer at The UCL EGA Institute for Women’s Health, and the NIHR University College London Hospitals Biomedical Research Centre, London, UK, and supported by the NIHR Oxford Biomedical Research Centre. The study was peer-reviewed and selected by the UCL Faculty of Biomedical Sciences for a ‘Grand Challenge 100’ studentship award. The funders had no role in the study design; collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication. The views expressed are those of the authors and not necessarily those of the NHS, the NIHR, or the Department of Health and Social Care.

  • Competing interests DAK and RJB are volunteers for the charity Weight Concern, which developed the 'Shape-Up' program for the general population.

  • Ethics approval The study protocol and documents have been reviewed and approved by the relevant sponsor and National Research Ethics Service Committee London – City Road and Hampstead (Reference: 15/LO/0154, 17 March 2015).

  • Provenance and peer review Not commissioned; externally peer reviewed.

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