Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention (SoFiT)

Wageningen University

Status: Active, not recruiting

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

Treatments: Behavioral: Behaviour change guided lifestyle intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05390398

NL75999.091.21

Details and patient eligibility

About

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.

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

Colorectal cancer survivors who completed treatment six months to five years ago and who suffer from cancer-related fatigue, are randomized into two parallel groups: an intervention group or the wait-list usual care group. The intervention group follows a six-month personalized lifestyle program, which is guided by behaviour change techniques, to increase adherence to the World Cancer Research Fund cancer prevention guidelines on healthy nutrition, physical activity and healthy weight. Participants are guided by a lifestyle coach specialized in behaviour change. The wait-list usual care group receives 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.

Both groups participate in measurements at baseline, three months, at the end of the intervention (six months) and at follow-up (twelve months). The follow-up timepoint is included to study long-term behavioural lifestyle change. The primary outcome is the change in cancer-related fatigue, as measured by the FACIT-Fatigue questionnaire, between the intervention and wait-list usual care group from baseline till six months.

Secondary outcomes include cancer-related fatigue (at other timepoints), skeletal muscle fat infiltration and cross-sectional area, gut microbiota composition, health-related quality of life, physical performance, sleep quality and duration, depression and anxiety, behavioural determinants and adherence to the WCRF guidelines by assessing habitual dietary intake, physical activity level, height, weight, waist circumference and BMI. Other outcomes of interest include, blood pressure, chrono-nutrition, colorectal cancer related complaints, hemoglobin blood levels, self-reported weight (at three months) and cost-effectiveness evaluation. Moreover, the following data will be collected to characterize the population: sociodemographic information (age, sex, marital status, education, smoking) and clinical parameters (time since diagnosis, current and received treatment, comorbidities, medicine and supplement use).

Enrollment: 184 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 2 patient groups

Intervention group

Experimental 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.

Treatment:

Behavioral: Behaviour change guided lifestyle intervention

Wait-list usual care group

No Intervention 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.