Feasibility and Acceptability of Exercise as a Lifestyle Intervention in Endometrial Cancer Survivors.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- The number of invited participants that complete the tailored exercise programme (10 exercise sessions).
Study Overview
Brief Summary
The purpose of the study is to evaluate the feasibility of introducing an exercise programme for endometrial cancer survivors.
Detailed Description
Objectives
- To evaluate the feasibility of an exercise intervention for endometrial cancer survivors in terms of recruitment, adherence, response rates, and follow-up rate.
- To evaluate the feasibility of the individual components of the exercise programme itself within the study population.
- To evaluate if the outcomes measure used to evaluate quality of life outcomes such as psychological distress, fatigue and pain in endometrial cancer survivors are appropriate.
- To evaluate if the outcome measures used to evaluate physical fitness are appropriate.
- To evaluate the acceptability of an exercise intervention for endometrial cancer survivors to improve quality of life outcomes.
General research design Single-arm prospective feasibility study In addition we will conduct a qualitative evaluation with a purposively selected subgroup with maximum variation of our population.
Study population All women diagnosed at the Royal Cornwall Hospital with endometrial cancer who have completed surgical treatment.
Number of participants Every year approximately 90 women are diagnosed with endometrial cancer at the Royal Cornwall Hospital in Truro, of which approximately 80 women receive primary surgical treatment. We estimate that 50% to 60% will consent to participation in this study; we therefore anticipate that the sample size for a study duration of 12 months will be approximately 40 to 48 women.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed diagnosis of endometrial cancer
- •Completion of surgical treatment for endometrial cancer
- •Age; 18 years or older.
Exclusion Criteria
- •Women receiving treatment in the palliative setting
- •Women with recurrent diagnosis of endometrial cancer
- •Women with concurrent cancer
- •Women who are unable to give informed consent
Outcomes
Primary Outcomes
The number of invited participants that complete the tailored exercise programme (10 exercise sessions).
Time Frame: 18 months
The overall aim of this proposed feasibility study is to ensure that a larger trial can successfully be planned and delivered.
Secondary Outcomes
- Change from baseline in the Brief Fatigue Inventory outcome measures at 18 months and change from baseline in the Brief Pain Inventory outcome measures at 18 months.(18 months)
- Change from baseline in the EORCT QLQ-C30 quality of life outcome measures at 18 months and change from baseline in the QLQ-EN24 quality of life outcome measures at 18 months.(18 months)
Investigators
Khadra Galaal
Consultant Gynaecological Oncologist
Royal Cornwall Hospitals Trust