N/A
N=54
Diet and Physical Activity in Uterine Cancer Survivors
Endometrial Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT02433080 ↗Enrolled (actual)
54
Serious AEs
5.6%
Results posted
May 2020
Primary outcome: Primary: Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study) — 20.3 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Shape-Up following cancer treatment (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University College, London
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recruitment Rate (Percentage of Potentially Eligible Participants Who Were Enrolled to the Study) |
20.3 | — |
| SECONDARY Change From Baseline in Health-related Quality of Life Score |
3.0; 8.7; 8.7; -1.4 | 0.05 |
| SECONDARY Change From Baseline in Dietary Quality (24-h Dietary Recall) |
4.4; -2.9; 3.0; 2.2 | — |
| SECONDARY Change From Baseline in Physical Activity (Physical Activity Recall) |
-1.4; -1.8; 0.2; 0.4 | — |
| SECONDARY Change From Baseline in Hand-grip Strength |
-0.3; -1.7; 0.0; -1.3 | — |
| SECONDARY Change From Baseline in Weight |
-0.9; 0.3; -1.1; -0.2 | — |
| SECONDARY Change From Baseline in Fat Mass Index |
-0.1; 0.1; -0.4; -0.2 | — |
| SECONDARY Intervention Evaluation Questionnaire |
0.2; -0.2; 0.1; -0.1 | — |
| SECONDARY Health Care Services Use - Medication |
1.4; 1.5 | — |
| SECONDARY Adherence Rate |
20 | — |
| SECONDARY Retention Rate |
25; 24 | — |
| SECONDARY Health Care Services Use - Number of General Practitioner Visits |
1.2; 1.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Women aged >18 years (no upper age limit)
- Women diagnosed with endometrial cancer (C54.1) within the previous 36 months
- Women who are able to understand spoken and written English
Exclusion Criteria
- Women with stage IVB (metastatic) endometrial cancer (any metastasis beyond the pelvis)
- Women on active anti-cancer, and/or palliative treatment,
- Women having second primary cancer
- 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)
- Women with severe depression (upon consultant's judgement based on the Diagnostic and Statistical Manual of Mental Disorders-IV criteria)
- Women unavailable for longitudinal follow-up assessments
- Women who participated in a professionally delivered weight loss or exercise program during the previous 6 months
- Women with a World Health Organization performance score 3-4
Data sourced from ClinicalTrials.gov (NCT02433080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.