An interventional study of Behaviour change guided lifestyle intervention in Colorectal Cancer, Cancer-related Fatigue and Colon Cancer, sponsored by Wageningen University. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-28.
Sponsored by Wageningen University · Not applicable, Interventional, and Treatment
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.
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).
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Exclusion Criteria:
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
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.
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.
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.
Time frame: Baseline till six months
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.
Time frame: Twelve months
Skeletal muscle fat infiltration and muscle circumference
Echo intensity of the skeletal muscle rectus femoris, lateral gastrocnemius and biceps brachialis is measured using a portable ultrasound machine.
Time frame: Baseline and six months
Gut microbiota composition
Faecal samples are collected and the microbiota composition in this will be analyzed. The investigators will use 16S rRNA sequencing data for the taxonomic characterization of the gut microbiota. Eventually shotgun sequencing may also be done.
Time frame: Baseline and six months
Health-related quality of life
Health-related quality of life is measured with the Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire, which contains the following domains of well-being: physical, social/family, emotional and functional. The 27-item questionnaire has scores ranging from 0 to 108.
Time frame: Baseline and six months
Physical performance (3-minute step test)
This test indicates cardiovascular fitness by heart rate measurement for one minute after the completion of three minutes of stepping.
Time frame: Baseline and six months
Physical performance (5 times sit-to-stand test)
This test indicates lower extremity skeletal muscle strength. The time necessary to achieve the standing position on the 5th repetition is measured.
Time frame: Baseline and six months
Physical performance (tandem test)
This test measures balance for three different standing positions. Each position has to be maintained for 10 seconds in order to pass the test.
Time frame: Baseline and six months
Physical performance (chair sit-and-reach test)
This test measures lower extremity and lower back flexibility. Participants sit on a chair and bend forward and reach for their toes. The distance between the hand and toes is measured.
Time frame: Baseline and six months
Physical performance (strength: hand dynamometer)
This test uses a hand dynamometer to measure strength.
Time frame: Baseline and six months
Sleep quality and duration (Pittsburgh Sleep Quality Index)
Sleep quality is measured with the Pittsburgh Sleep Quality Index (PSQI), a 19-item questionnaire with scores ranging from 0-21. A score above 5 indicates bad sleep quality.
Time frame: Baseline, six months and 12 months
Sleep quality and duration (Consensus sleep diary morning)
The Consensus sleep diary morning (CSD), a 15-item diary, is used for measuring other sleep outcomes such as sleep onset latency and sleep duration.
Time frame: Baseline and six months
Depression
Depression is measured using the 8-item Patient Healthcare Questionnaire (PHQ-8). It contains 8 items, and scores range from 0-24, with higher scores indicating a higher chance of depression.
Time frame: Baseline and six months
Anxiety
Anxiety is measured using the 7-item Generalized Anxiety Disorder (GAD-7). The GAD-7 contains 7 items, its scores range from 0-21, with higher scores indicating a higher chance of anxiety.
Time frame: Baseline and six months
Behavioural determinants
Identified behavioural determinants through focus groups and a systematic review, are assessed using a self-reported questionnaire with questions based on previous reported questions on different determinants. These were adapted to reflect the WCRF guidelines. Higher scores for each of the determinants (scale 1-7) indicate better results.
Time frame: Baseline, three months, six months and twelve months.
Habitual dietary intake (Food Frequency Questionnaire)
Nutritional intake is measured using a semi-quantitative Food Frequency Questionnaire (FFQ). Scores are calculated using the Dutch National Food Consumption tables. In addition, the validated questionnaire Eetscore is used, which contains a short online questionnaire (10-15 minutes) that serves as an indicator to assess diet quality, based on the Dutch Healthy Diet index 2015 (DHD15-index). Scores range from 0-160, with higher scores indicating better diet quality.
Time frame: Baseline, six months and twelve months
Habitual dietary intake (Eetscore)
Nutritional intake is also measured using the validated questionnaire Eetscore, which uses a short online questionnaire (10-15 minutes) that serves as an indicator to assess diet quality, based on the Dutch Healthy Diet index 2015 (DHD15-index). Scores range from 0-160, with higher scores indicating better diet quality.
Time frame: Baseline, three months, six months and twelve months
Physical activity level (Short QUestionnaire to ASsess Health-enhancing physical activity)
Physical activity is measured using the Short QUestionnaire to ASsess Health-enhancing physical activity (SQUASH). The questions in the SQUASH are pre-structured in commuting, leisure time, household and work/school activities. Scores will be assigned to the different reported activities base on intensities in MET and translated to minutes of physical activity.
Time frame: Baseline, three months, six months and twelve months
Physical activity level (Accelerometer)
Physical activity is also measured using ActivPalTM Micro3, an accelerometer measuring sedentary behaviour and physical activity. The ActivPalTM is worn for 9 days.
Time frame: Baseline and six months
Anthropometric measurements (Height)
Height (in cm) is measured with a stadiometer.
Time frame: Baseline and six months
Anthropometric measurements (Weight)
Weight (in kg) is measured with a calibrated scale.
Time frame: Baseline, three months (self-reported) and six months
Anthropometric measurements (Waist circumference)
Waist circumference (in cm) is measured using tape measures.
Time frame: Baseline and six months
Cost-effectiveness evaluation
The cost-effectiveness of the intervention is evaluated using a questionnaire that includes items on for example costs that the participant has made in order to follow the lifestyle program.
Time frame: Baseline, three months and six months
Blood pressure
Blood pressure is measured using a sphygmomanometer. Both diastolic and systolic blood pressure are measured.
Time frame: Baseline and six months
Heart rate
Heart rate is measured using a sphygmomanometer.
Time frame: Baseline and six months
Chrono-nutrition
Chrono-nutrition, the timing of dietary intake, is measured with the "Chromes vragenlijst patiënten eetpatronen". This is a Dutch questionnaire containing 26 items that assess meal regularity (8-items), meal frequency (7-items), and meal clock time (11-items).
Time frame: Baseline and six months
Colorectal cancer related complaints
Measuring colorectal cancer specific problems is done using the additional concerns (i.e. subscale) of the Functional Assessment of Cancer Therapy - Colorectal (FACT-C). This questionnaire contains 9 items and scores are ranging from 0-28 points.
Time frame: Baseline and six months
Hemoglobin levels
Finger prick blood sampling is used for assessing haemoglobin status as an indicator for anaemia.
Time frame: Baseline and six months
Sociodemographic information
Sociodemographic information is collected using standardized questionnaires.
Time frame: Baseline (and six months)
Clinical parameters
Clinical parameters such as time since diagnosis, current and received treatment, comorbidities and medicine use, are collected either via standardized questionnaires or from medical records (part of informed consent).
Time frame: Baseline (and six months)
Plan to share: No
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Wageningen University