Diet and Physical Activity in Uterine Cancer Survivors

Endometrial Neoplasms Clinical Trial

— DEUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02433080
• Other study ID #: 14/0765
• Status: Completed
• Phase: N/A
• Start date: April 2015
• Est. completion date: June 2016

Study information

• Verified date: May 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Women aged >18 years (no upper age limit)

2. Women diagnosed with endometrial cancer (C54.1) within the previous 36 months

3. Women who are able to understand spoken and written English

Exclusion Criteria:

1. Women with stage IVB (metastatic) endometrial cancer (any metastasis beyond the pelvis)

2. Women on active anti-cancer, and/or palliative treatment,

3. Women having second primary cancer

4. Women who lack mental capacity to decide to take part in the study and to participate in it (upon clinical team's judgement in accordance with the Mental Capacity Act 2005 Code of Practice 2007)

5. Women with severe depression (upon consultant's judgement based on the Diagnostic and Statistical Manual of Mental Disorders-IV criteria)

6. Women unavailable for longitudinal follow-up assessments

7. Women who participated in a professionally delivered weight loss or exercise program during the previous 6 months

8. Women with a World Health Organization performance score 3-4

Related Conditions & MeSH terms

• Endometrial Neoplasms

Intervention

Behavioral:
• Shape-Up following cancer treatment
The programme is based on "Social Cognitive Theory" and "Control Theory". The focus of the programme lies on self-control, self-efficacy, and relapse prevention.

Locations

Country	Name	City	State
United Kingdom	Barts Health NHS Trust	London	Greater London
United Kingdom	University College London Hospital NHS Trust	London	Greater London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

References & Publications (2)

Chiuve SE, Fung TT, Rimm EB, Hu FB, McCullough ML, Wang M, Stampfer MJ, Willett WC. Alternative dietary indices both strongly predict risk of chronic disease. J Nutr. 2012 Jun;142(6):1009-18. doi: 10.3945/jn.111.157222. Epub 2012 Apr 18. — View Citation

Koutoukidis DA, Lopes S, Atkins L, Croker H, Knobf MT, Lanceley A, Beeken RJ. Use of intervention mapping to adapt a health behavior change intervention for endometrial cancer survivors: the shape-up following cancer treatment program. BMC Public Health. 2018 Mar 27;18(1):415. doi: 10.1186/s12889-018-5329-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study)	Achieving a 30% recruitment rate of the potentially eligible participants	6 months
Secondary	Change From Baseline in Health-related Quality of Life Score	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 Global quality of life scale ranging from 0-100 with higher scores indicating better quality of life	Baseline, 8weeks, 24weeks
Secondary	Change From Baseline in Dietary Quality (24-h Dietary Recall)	One 24-h dietary recall for each timepoint. This is the combined total Alternate healthy eating index-2010 score ranging from 0-110 with higher scores indicating higher dietary quality.	Baseline, 8weeks, 24weeks
Secondary	Change From Baseline in Physical Activity (Physical Activity Recall)	7-day physical activity recall	Baseline, 8weeks, 24weeks
Secondary	Change From Baseline in Hand-grip Strength		Baseline, 8weeks, 24weeks
Secondary	Change From Baseline in Weight		Baseline, 8weeks, 24weeks
Secondary	Change From Baseline in Fat Mass Index	Using MC980 multi-frequency segmental body composition analyser. Fat mass index was calculated as kg of fat mass divided by squared height in meters.	Baseline, 8weeks, 24weeks
Secondary	Intervention Evaluation Questionnaire	Change in the self-assessment of the gained skills (Shape-Up self-efficacy score). This is a total score 0-5 with higher scores indicating higher self-efficacy.	8weeks, 24weeks
Secondary	Health Care Services Use - Medication	Number of currently prescribed medications over the 24 weeks of the trial (Self-reported)	24weeks
Secondary	Adherence Rate	The percentage 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.	8 weeks
Secondary	Retention Rate	Rate of complete follow-up	Baseline to 24weeks
Secondary	Health Care Services Use - Number of General Practitioner Visits	Number of visits to their general practitioner over the 24 weeks of the trial (Self-reported)	24weeks