Clinical trial NCT02433080: Diet and Physical Activity in Uterine Cancer Survivors
Official title: Randomised, Controlled, Pilot Clinical Trial to Assess the Feasibility of a Healthy Eating and Physical Activity Program in Endometrial Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Neoplasms
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2015-05-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study)
timeFrame: 6 months
Secondary outcomes:
measure: Change From Baseline in Health-related Quality of Life Score
timeFrame: Baseline, 8weeks, 24weeks
measure: Change From Baseline in Dietary Quality (24-h Dietary Recall)
timeFrame: Baseline, 8weeks, 24weeks
measure: Change From Baseline in Physical Activity (Physical Activity Recall)
timeFrame: Baseline, 8weeks, 24weeks
measure: Change From Baseline in Hand-grip Strength
timeFrame: Baseline, 8weeks, 24weeks
measure: Change From Baseline in Weight
timeFrame: Baseline, 8weeks, 24weeks
measure: Change From Baseline in Fat Mass Index
timeFrame: Baseline, 8weeks, 24weeks
measure: Intervention Evaluation Questionnaire
timeFrame: 8weeks, 24weeks
measure: Health Care Services Use - Medication
timeFrame: 24weeks
measure: Adherence Rate
timeFrame: 8 weeks
measure: Retention Rate
timeFrame: Baseline to 24weeks
measure: Health Care Services Use - Number of General Practitioner Visits
timeFrame: 24weeks
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Barts Health NHS Trust
state: Greater London
city: London
country: United Kingdom
facility: University College London Hospital NHS Trust
state: Greater London
Study officials:
affiliation: University College, London
name: Anne Lanceley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Koutoukidis DA, Beeken RJ, Manchanda R, Burnell M, Ziauddeen N, Michalopoulou M, Knobf MT, Lanceley A. 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. Int J Gynecol Cancer. 2019 Mar;29(3):531-540. doi: 10.1136/ijgc-2018-000039. Epub 2019 Feb 4.
citation: Koutoukidis DA, Beeken RJ, Manchanda R, Michalopoulou M, Burnell M, Knobf MT, Lanceley A. 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. BMJ Open. 2017 Oct 8;7(10):e018015. doi: 10.1136/bmjopen-2017-018015.
citation: Koutoukidis DA, Beeken RJ, Manchanda R, Burnell M, Knobf MT, Lanceley A. Diet and exercise in uterine cancer survivors (DEUS pilot) - piloting a healthy eating and physical activity program: study protocol for a randomized controlled trial. Trials. 2016 Mar 10;17(1):130. doi: 10.1186/s13063-016-1260-1.