Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention

NCT05390398 | Completed

• 1 other identifier: NL75999.091.21
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

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 guidelines, compared to the wait-list usual care group, on diminishing cancer-related fatigue in colorectal cancer survivors.

Conditions

Colorectal Cancer; Cancer-related Fatigue; Colon Cancer; Rectal Cancer

Keywords

Intervention study; Randomized controlled trial; Lifestyle; Behaviour change; Colorectal cancer survivors; Cancer-related fatigue; Lifestyle coach; Nutrition; Physical activity; Skeletal muscle fat infiltration

Outcome Measures

Primary Outcomes (1)

• Change in cancer-related fatigue

  Cancer-related fatigue is assessed with the FACIT-Fatigue Scale, a 13 item questionnaire with scores ranging from 0-52. A score below 34 indicates fatigue. The minimal clinically important difference is reported to be 3.0 for this scale.

  Baseline till six months

Secondary Outcomes (22)

• Cancer-related fatigue

  Twelve months

• Skeletal muscle fat infiltration and muscle circumference

  Baseline and six months

• Gut microbiota composition

  Baseline and six months

• Health-related quality of life

  Baseline and six months

• Physical performance (3-minute step test)

  Baseline and six months

Other Outcomes (7)

• Blood pressure

  Baseline and six months

• Heart rate

  Baseline and six months

• Chrono-nutrition

  Baseline and six months

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Behavioral: Behaviour change guided lifestyle intervention

Wait-list usual care group

NO INTERVENTION

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.

Interventions

Behaviour change guided lifestyle intervention BEHAVIORAL

Participants in the intervention group receive personalized coaching from a lifestyle coach on adhering to the World Cancer Research Fund cancer prevention guidelines. The lifestyle coach is specialized in behaviour change techniques and uses these as the core of the lifestyle coaching. For each participant behavioural determinants will be assessed and targeted with specific applicable behaviour change techniques.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wageningen University: lead
• World Cancer Research Fund International: collaborator
• Gelderse Vallei Hospital: collaborator
• Flevoziekenhuis: collaborator
• Slingeland Hospital: collaborator
• Rijnstate Hospital: collaborator
• Het Prospectief Landelijk CRC cohort (PLCRC): collaborator
• Deventer Ziekenhuis: collaborator

Study Sites (1)

Wageningen University & Research

Wageningen, Gelderland, 6708WE, Netherlands

Location

Related Publications (1)

• de 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 DERIVED

Related Links

• Information about the SoFiT study

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms; Motor Activity

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The nature of the intervention does not allow for blinding of the participants or researchers. The baseline measurements are however blinded as both the participant and the researchers do not yet know in which group the participant will be classified. Randomization is done directly after the baseline measurements. After data collection, the database will be coded by an independent researcher to ensure that data analysis is conducted in a blinded way.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Ir.

Model Details: Randomized controlled trial with two parallel arms: intervention and control.

Study Record Dates

• First Submitted: March 24, 2022
• First Posted: May 25, 2022
• Study Start: January 18, 2022
• Primary Completion: June 30, 2024
• Study Completion: December 31, 2024
• Last Updated: March 28, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)