Clinical Trial: Diet and Physical Activity in Uterine Cancer Survivors

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Randomised, Controlled, Pilot Clinical Trial to Assess the Feasibility of a Healthy Eating and Physical Activity Program in Endometrial Cancer Survivors

Brief Summary:

Endometrial cancer is the most common gynaecological cancer in developed countries with more than 75% of the patients surviving for at least five years. However, most endometrial cancer survivors are overweight and obese and do not meet the current nutrition and physical activity recommendations. This can lower their quality of life and increase their risk for chronic diseases. Behaviour change interventions can help them feel better about themselves and improve their quality of life. Applying them shortly after treatment seems ideal as cancer survivors feel motivated to make changes about their lifestyle at this time point.

This study is to see if the investigators can design a project to measure how well a psycho-educational healthy eating and physical activity programme tailored to the survivors' needs works. Sixty-four endometrial cancer survivors diagnosed during the previous three years, and are all clear will be put by chance into one of two groups. One will receive the program. The other will receive usual care until the end of the trial and, then, a discussion and a self-help guide about eating well and being active following cancer treatment. This will help us to see if the programme makes a difference compared with usual care. The results will inform a larger study to test if a lifestyle program can improve the quality of life of uterine cancer survivors compared with usual care. The investigators will change the programme materials in response to the investigators' findings, making them available to services. The results will inform practice and research.


Detailed Summary:

Low physical activity, poor diet and obesity are risk factors for the development of endometrial cancer. A growing body of evidence suggests that they may be linked with quality of life after cancer treatment. However, only about 1% of endometrial cancer survivors seem to meet the current fruit and vegetable, physical activity, and non-smoking recommendations; while 57% meets only the non-smoking recommendations, and 22% meet none of the recommendations,

These behaviours exist despite cancer diagnosis being perceived as a "teachable moment". Capitalising the "teachable moment" of cancer, behaviour change interventions in high-risk populations might be more effective than those targeting the general population.

Theory-based behaviour change interventions suggest that improving diet and physical activity is safe, acceptable, and feasible and can help cancer survivors improve their quality of life. In contrast, there are only limited studies to support these data in the UK to allow generalisability of these results. However, the majority of these interventions were long-term and resource intensive which may render them inappropriate for wide dissemination. Therefore, feasible and effective interventions are needed to promote implementation of the nutrition and physical activity guidelines.

The intervention is based on the Shape-Up eight-week weight management programme. This programme is based on "Social Cognitive Theory" and "Control Theory". A version of this program has been favourably evaluated in terms of acceptability, physical, and psychological outcomes. We have tailored this programme (Shape-Up following cancer treatment) to help endometrial cancer survivors improve their diet, and activity pattern. The focus of the programme li
Sponsor: University College, London

Current Primary Outcome: Recruitment rate [ Time Frame: 6 months ]

Recruiting 30% of the eligible participants


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Health-related quality of life (EORTC QLQ C30 & EN24) [ Time Frame: Baseline, 8weeks, 24weeks ]
    European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 & European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module 24
  • Dietary quality (24-h dietary recall) [ Time Frame: Baseline, 8weeks, 24weeks ]
    One 24-h dietary recall for each timepoint
  • Physical activity (physical activity recall) [ Time Frame: Baseline, 8weeks, 24weeks ]
    7-day physical activity recall
  • Hand-grip strength [ Time Frame: Baseline, 8weeks, 24weeks ]
  • Weight [ Time Frame: Baseline, 8weeks, 24weeks ]
  • Body composition (MC980 multi-frequency segmental body composition analyser) [ Time Frame: Baseline, 8weeks, 24weeks ]
    Using MC980 multi-frequency segmental body composition analyser
  • Intervention evaluation questionnaire [ Time Frame: 8weeks ]
    Self-assessment of the gained skills and an evaluation of the facilitator
  • Health care services use [ Time Frame: 24weeks ]
  • Adherence rate [ Time Frame: 8 weeks ]
    The proportion of engaged participants attending at least one of the last three sessions of the intervention. Engaged participants are those who have attended at least two sessions of the intervention.
  • Retention rate [ Time Frame: Baseline to 24weeks ]
    Rate of complete follow-up


Original Secondary Outcome: Same as current

Information By: University College, London

Dates:
Date Received: April 20, 2015
Date Started: April 2015
Date Completion:
Last Updated: October 25, 2016
Last Verified: August 2015