Clinical trial · Interventional
Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention
NCT05390398CI-TRIAL-00087818SoFiTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer-related Fatigue | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Behaviour change guided lifestyle intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- The intervention group follows a six-month personalized lifestyle program to increase adherence to the World Cancer Research Fund cancer prevention guidelines on healthy nutrition, physical activity and healthy weight.
- interventionNames
- Behavioral: Behaviour change guided lifestyle intervention
- type
- NO_INTERVENTION
- label
- Wait-list usual care group
- description
- The wait-list usual care group follows usual care and usual activities. Participants receive a lifestyle program after the intervention period of six months: this includes two personalized behavioural coaching sessions and any material that the intervention group also received.
Primary outcomes (1)
- measure
- Change in cancer-related fatigue
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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)
References
Publications (1)
- DERIVEDde Vries-Ten Have J, Manusama K, Verkaar AJCF, Beijer S, Sommeijer DW, Kampman E, Winkens LHH, Winkels RM. A randomised controlled intervention trial to study the effect of a personalised lifestyle programme on cancer-related fatigue among colorectal cancer survivors: protocol for the SoFiT study. Br J Nutr. 2024 Jul 28;132(2):248-258. doi: 10.1017/S0007114524001107. Epub 2024 May 28. PMID 38804183