Status:
COMPLETED
Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention
Lead Sponsor:
Wageningen University
Collaborating Sponsors:
World Cancer Research Fund International
Gelderse Vallei Hospital
Conditions:
Colorectal Cancer
Cancer-related Fatigue
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The SoFiT study is a randomized controlled trial examining the effects of a behaviour change guided lifestyle intervention on increasing adherence to the World Cancer Research Fund cancer prevention g...
Detailed Description
The SoFiT study is a randomized controlled trial examining the effects of a behaviour change guided lifestyle intervention on increasing adherence to the World Cancer Research Fund (WCRF) cancer preve...
Eligibility Criteria
Inclusion
- Aged 18 or above.
- Completed curative stage I-III colorectal cancer treatment in the previous 6 months to 5 years.
- Live on a reasonable distance from the research center at the Wageningen University \& Research (WUR) (i.e. maximum of ± 1 hour away).
- Classified as suffering from CRF through the Functional Assessment of Chronic Illness Therapy (FACIT) - Fatigue Scale questionnaire with cut-off score below 34 indicating fatigue.
- Willingness to be randomized into either the intervention or wait-list control group.
- Willing and able to follow the lifestyle intervention.
- Able to understand and provide informed consent in Dutch.
Exclusion
- Planning to participate or participating in another medical research that could possibly interfere with the study results.
- Excessive alcohol consumption (i.e. more than 4 glasses per day).
- Chronic drug use and unwillingly to stop using drugs.
- Unable/unwilling to comply with the intervention (e.g. through dementia, Alzheimer or mental illness)
Key Trial Info
Start Date :
January 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT05390398
Start Date
January 18 2022
End Date
December 31 2024
Last Update
March 28 2025
Active Locations (1)
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1
Wageningen University & Research
Wageningen, Gelderland, Netherlands, 6708WE