Diet and Physical Activity in Uterine Cancer Survivors

NCT02433080CompletedNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

University College, London

Enrollment

60

Start Date

2015-04-01

Completion Date

2015-12-01

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

Interventions

Shape-Up following cancer treatment

Conditions

Endometrial Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study)

Achieving a 30% recruitment rate of the potentially eligible participants

Time frame: 6 months

Secondary Outcomes

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

Time frame: Baseline, 8weeks, 24weeks

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.

Time frame: Baseline, 8weeks, 24weeks

Change From Baseline in Physical Activity (Physical Activity Recall)

7-day physical activity recall

Time frame: Baseline, 8weeks, 24weeks

Change From Baseline in Hand-grip Strength

Time frame: Baseline, 8weeks, 24weeks

Change From Baseline in Weight

Time frame: Baseline, 8weeks, 24weeks

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.

Time frame: Baseline, 8weeks, 24weeks

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.

Time frame: 8weeks, 24weeks

Health Care Services Use - Medication

Number of currently prescribed medications over the 24 weeks of the trial (Self-reported)

Time frame: 24weeks

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.

Time frame: 8 weeks

Retention Rate

Rate of complete follow-up

Time frame: Baseline to 24weeks

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)

Time frame: 24weeks

Locations

Barts Health NHS Trust, London, United Kingdom

University College London Hospital NHS Trust, London, United Kingdom

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.

Diet and Physical Activity in Uterine Cancer Survivors