Diet and Physical Activity in Uterine Cancer Survivors

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02433080

Acronym

DEUS

Enrollment

Registered

2015-05-04

Start date

2015-04-30

Completion date

2016-06-30

Last updated

2020-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Neoplasms

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.

Interventions

BEHAVIORALShape-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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study)	6 months	Achieving a 30% recruitment rate of the potentially eligible participants

Secondary

Measure	Time frame	Description
Change From Baseline in Dietary Quality (24-h Dietary Recall)	Baseline, 8weeks, 24weeks	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.
Change From Baseline in Physical Activity (Physical Activity Recall)	Baseline, 8weeks, 24weeks	7-day physical activity recall
Change From Baseline in Hand-grip Strength	Baseline, 8weeks, 24weeks	—
Change From Baseline in Weight	Baseline, 8weeks, 24weeks	—
Change From Baseline in Fat Mass Index	Baseline, 8weeks, 24weeks	Using MC980 multi-frequency segmental body composition analyser. Fat mass index was calculated as kg of fat mass divided by squared height in meters.
Change From Baseline in Health-related Quality of Life Score	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 Global quality of life scale ranging from 0-100 with higher scores indicating better quality of life
Health Care Services Use - Medication	24weeks	Number of currently prescribed medications over the 24 weeks of the trial (Self-reported)
Adherence Rate	8 weeks	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.
Retention Rate	Baseline to 24weeks	Rate of complete follow-up
Health Care Services Use - Number of General Practitioner Visits	24weeks	Number of visits to their general practitioner over the 24 weeks of the trial (Self-reported)
Intervention Evaluation Questionnaire	8weeks, 24weeks	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.

Countries

United Kingdom

Participant flow

Pre-assignment details

Although 60 participants were enrolled, only 54 were included in the study analysis as the remaining 6 participants were deemed ineligible to participate and excluded from the analysis.

Participants by arm

Arm	Count
Shape-Up Following Cancer Treatment In addition to usual care, cancer survivors in the intervention group will participate in a behaviour change programme, called Shape-Up following cancer treatment: a self-help programme on eating well and being active. Participants will be allocated to groups of eight to ten. These groups will meet every week for eight weeks and each session will last approximately 90 minutes. The programme focuses on strategies for improving diet and physical activity in a self-help and peer education format. Each week, one participant will volunteer to present a new concept (e.g. regular eating, being active, eating a balanced diet, keep an eye on portion sizes, and manage internal and external triggers, and understanding food labeling) to the rest of the group. 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.	25
Control Intervention Participants in the control group will be offered usual care until the 24-week follow-up. Quantifying usual care is challenging, but preliminary qualitative work suggested that most survivors do not received any unsolicited advice about healthy eating and physical activity from their health care professionals after treatment. During the course of their participation in the trial, participants will be contacted only for the assessments. After the completion of the 24-week follow-up, participants will receive the booklet Healthy living after cancer; a brief self-help manual produced by the World Cancer Research Fund. Providing only this information aims to match the currently offered usual care as accurately as possible but also meet ethical standards.	24
Total	49

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Lost to Follow-up	1	2
Overall Study	Withdrawal by Subject	0	2

Baseline characteristics

Characteristic	Shape-Up Following Cancer Treatment	Control Intervention	Total
Age, Continuous	62.6 years STANDARD_DEVIATION 9	61.5 years STANDARD_DEVIATION 7.7	62.1 years STANDARD_DEVIATION 8.3
Region of Enrollment United Kingdom	25 participants	24 participants	49 participants
Sex: Female, Male Female	25 Participants	24 Participants	49 Participants
Sex: Female, Male Male	0 Participants	0 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 26	0 / 28
other Total, other adverse events	0 / 26	0 / 28
serious Total, serious adverse events	0 / 26	3 / 28

Outcome results

Primary

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

Population: Of the 296 potentially eligible participants, 20.3% were enrolled in the study.

Arm	Measure	Value (NUMBER)
Both Arms Combined	Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study)	20.3 percentage of participants

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.

Time frame: 8 weeks

Arm	Measure	Value (COUNT_OF_PARTICIPANTS)
Both Arms Combined	Adherence Rate	20 Participants

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.