Clinical trial · Interventional

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

NCT02433080CI-TRIAL-00045146DEUScompletedN/AResults postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Endometrial Neoplasms	Endometrial Neoplasm	ONTOLOGY_EXACT	0.98

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Shape-Up following cancer treatment	Behavioral	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
ACTIVE_COMPARATOR
label
Shape-Up following cancer treatment
description
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.
interventionNames
1. Behavioral: Shape-Up following cancer treatment
type
NO_INTERVENTION
label
Control intervention
description
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.

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (5)

BACKGROUNDChiuve 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. PMID 22513989
BACKGROUNDKoutoukidis 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. PMID 29587699
DERIVEDKoutoukidis 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. PMID 30723098
DERIVEDKoutoukidis 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. PMID 28993394
DERIVEDKoutoukidis 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. PMID 26965165

Registry

Dates and enrollment

Start: Apr 1, 2015
Primary completion: Dec 1, 2015
Completion: Jun 1, 2016
First posted: May 4, 2015
Last update posted: May 19, 2020
Results first posted: May 19, 2020
Enrollment: 60 (actual)
Lead sponsor: University College, London OTHER

Data updated 22 days agoSource updated May 19, 2020source: clinicaltrials

Locations

Locations by country (2)

Country	Sites	Recruiting
United Kingdom	2	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.