Clinical trial NCT05390398: Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention
Official title: Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Wageningen University
Sponsor class: OTHER
Collaborators: name: World Cancer Research Fund International
name: Gelderse Vallei Hospital
name: Flevoziekenhuis
name: Slingeland Hospital
name: Rijnstate Hospital
name: Het Prospectief Landelijk CRC cohort (PLCRC)
name: Deventer Ziekenhuis
First posted: 2022-05-25
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial with two parallel arms: intervention and control.
Primary purpose: TREATMENT

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.

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 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).

Eligibility criteria: 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)

Primary outcomes:
measure: Change in cancer-related fatigue
timeFrame: Baseline till six months
Secondary outcomes:
measure: Cancer-related fatigue
timeFrame: Twelve months
measure: Skeletal muscle fat infiltration and muscle circumference
timeFrame: Baseline and six months
measure: Gut microbiota composition
timeFrame: Baseline and six months
measure: Health-related quality of life
timeFrame: Baseline and six months
measure: Physical performance (3-minute step test)
timeFrame: Baseline and six months
measure: Physical performance (5 times sit-to-stand test)
timeFrame: Baseline and six months
measure: Physical performance (tandem test)
timeFrame: Baseline and six months
measure: Physical performance (chair sit-and-reach test)
timeFrame: Baseline and six months
measure: Physical performance (strength: hand dynamometer)
timeFrame: Baseline and six months
measure: Sleep quality and duration (Pittsburgh Sleep Quality Index)
timeFrame: Baseline, six months and 12 months
measure: Sleep quality and duration (Consensus sleep diary morning)
timeFrame: Baseline and six months
measure: Depression
timeFrame: Baseline and six months
measure: Anxiety
timeFrame: Baseline and six months
measure: Behavioural determinants
timeFrame: Baseline, three months, six months and twelve months.
measure: Habitual dietary intake (Food Frequency Questionnaire)
timeFrame: Baseline, six months and twelve months
measure: Habitual dietary intake (Eetscore)
timeFrame: Baseline, three months, six months and twelve months
measure: Physical activity level (Short QUestionnaire to ASsess Health-enhancing physical activity)
timeFrame: Baseline, three months, six months and twelve months
measure: Physical activity level (Accelerometer)
timeFrame: Baseline and six months
measure: Anthropometric measurements (Height)
timeFrame: Baseline and six months
measure: Anthropometric measurements (Weight)
timeFrame: Baseline, three months (self-reported) and six months
measure: Anthropometric measurements (Waist circumference)
timeFrame: Baseline and six months
measure: Cost-effectiveness evaluation
timeFrame: Baseline, three months and six months
Other outcomes:
measure: Blood pressure
timeFrame: Baseline and six months
measure: Heart rate
timeFrame: Baseline and six months
measure: Chrono-nutrition
timeFrame: Baseline and six months
measure: Colorectal cancer related complaints
timeFrame: Baseline and six months
measure: Hemoglobin levels
timeFrame: Baseline and six months
measure: Sociodemographic information
timeFrame: Baseline (and six months)
measure: Clinical parameters
timeFrame: Baseline (and six months)
Locations:
city: Wageningen
country: Netherlands
facility: Wageningen University & Research
state: Gelderland
Study officials:
References: