Diet and Physical Activity in Uterine Cancer Survivors — DEUS  

Endometrial Neoplasms Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 United Kingdom 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 lies on self-control, self-efficacy, and relapse prevention in terms of healthy eating and physical activity. Behavioural techniques will include self-monitoring of behaviour with the use of food and physical activity diaries, behavioural goal setting, action planning, graded tasks, problem solving, self-reward, and review of behavioural goals. It will also provide information about health consequences and emotional consequences, pros and cons, behavioural practice, habit formation, reducing exposure to cues for the behaviour, behaviour substitution, distraction, social support (unspecified), demonstration of behaviour (for resistance exercises), instructions on how to perform the behaviour (for resistance exercises), and reframing.

The DEUS pilot trial is an eight-week, two-arm, individually randomised, controlled pilot trial comparing the use of the "Shape-Up following cancer treatment" programme to usual care. According to Medical Research Council guidance for complex interventions, this is a Phase 2 feasibility study. Randomisation will be performed with minimisation using a 1:1 allocation. ;

Related Conditions & MeSH terms

• Endometrial Neoplasms

• NCT number: NCT02433080
• Study type: Interventional
• Source: University College, London
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Completion date: June 2016