NCT05390398Completed
Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention
Source: ClinicalTrials.gov · Last updated 28 Mar 2025
Brief summary (registry, in English)
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 guidelines, compared to the wait-list usual care group, on diminishing cancer-related fatigue in colorectal cancer survivors.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 161 (actual)
- First submitted
- 24 Mar 2022
- Start date
- 18 Jan 2022
- Primary completion date
- 30 Jun 2024
- Lead sponsor
- Wageningen University
- Diseases
- Colorectal cancer
- NCT number
- NCT05390398
What you commit to
- Study type: Interventional
- Participants enrolled: 161
- From 18 Jan 2022 to the primary completion date, 30 Jun 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Chronic drug use and unwillingly to stop using drugs.
Other illness
- Unable/unwilling to comply with the intervention (e.g. through dementia, Alzheimer or mental illness)
Other
- 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).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wageningen University & Research Coordinator of this site? Confirm its status | Wageningen | Netherlands | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.