Exercise as an Intervention in Endometrial Cancer Survivors
Feasibility and Acceptability of Exercise as a Lifestyle Intervention in Endometrial Cancer Survivors.
1 other identifier
interventional
50
1 country
1
Brief Summary
The purpose of the study is to evaluate the feasibility of introducing an exercise programme for endometrial cancer survivors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
February 2, 2015
CompletedFirst Posted
Study publicly available on registry
February 20, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2016
CompletedFebruary 20, 2015
February 1, 2015
1 year
February 2, 2015
February 13, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
The number of invited participants that complete the tailored exercise programme (10 exercise sessions).
The overall aim of this proposed feasibility study is to ensure that a larger trial can successfully be planned and delivered.
18 months
Secondary Outcomes (2)
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
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
Study Arms (1)
Single Arm Study
EXPERIMENTALAll participants receive active treatment (exercise) tailored to their level of health ad fitness
Interventions
Eligibility Criteria
You may qualify if:
- Confirmed diagnosis of endometrial cancer
- Completion of surgical treatment for endometrial cancer
- Age; 18 years or older.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Royal Cornwall Hospital Trust
Truro, Cornwall, TR13LJ, United Kingdom
Related Publications (1)
Smits A, Lopes A, Das N, Bekkers R, Massuger L, Galaal K. Exercise Programme in Endometrial Cancer; Protocol of the Feasibility and Acceptability Survivorship Trial (EPEC-FAST). BMJ Open. 2015 Dec 16;5(12):e009291. doi: 10.1136/bmjopen-2015-009291.
PMID: 26674498DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Chris Cannaby, BA
United Kindom: Royal Cornwall Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant Gynaecological Oncologist
Study Record Dates
First Submitted
February 2, 2015
First Posted
February 20, 2015
Study Start
January 1, 2015
Primary Completion
January 1, 2016
Study Completion
July 1, 2016
Last Updated
February 20, 2015
Record last verified: 2015-02