Colorectal CancerSoFiTNCT05390398
Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention
A study testing Behaviour change guided lifestyle intervention in people with Colorectal Cancer and Cancer-related Fatigue, run by Wageningen University at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Cancer-related Fatigue, Colon Cancer
- What is being tested?
- Behaviour change guided lifestyle intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 1 siteNetherlands
- Study dates
- 18 Jan 2022to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Netherlands1 site
Wageningen University & Research
Wageningen, Gelderland, 6708WE
About this study
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.
Read the 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).
- Conditions
- Colorectal Cancer, Cancer-related Fatigue, Colon Cancer, Rectal Cancer
- Being tested
- Behaviour change guided lifestyle intervention
- Keywords
- Intervention study, Randomized controlled trial, Lifestyle, Behaviour change, Colorectal cancer survivors, Cancer-related fatigue, Lifestyle coach, Nutrition, Physical activity, Skeletal muscle fat infiltration
- Medical subject headings
- Colorectal Neoplasms, Colonic Neoplasms, Rectal Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behaviour change guided lifestyle interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline till six months
Secondary outcomes (22)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and six months
Physical performance (strength: hand dynamometer)
This test uses a hand dynamometer to measure strength.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and six months
Anthropometric measurements (Height)
Height (in cm) is measured with a stadiometer.
Measured: Baseline and six months
Anthropometric measurements (Weight)
Weight (in kg) is measured with a calibrated scale.
Measured: Baseline, three months (self-reported) and six months
Anthropometric measurements (Waist circumference)
Waist circumference (in cm) is measured using tape measures.
Measured: 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.
Measured: Baseline, three months and six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start18 Jan 2022
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two parallel arms: intervention and control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wageningen University
- Sponsor type
- University, hospital or other
- Collaborators
- World Cancer Research Fund International, Gelderse Vallei Hospital, Flevoziekenhuis, Slingeland Hospital, Rijnstate Hospital, Het Prospectief Landelijk CRC cohort (PLCRC), Deventer Ziekenhuis
- Responsible party
- Principal investigator, Renate Winkels, Wageningen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390398
- Sponsor's protocol ID
- NL75999.091.21
- Acronym
- SoFiT
- Status last verified
- Mar 2025
- First submitted
- 24 Mar 2022
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38804183
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention
- ClinicalTrials.gov ID
- NCT05390398
- Acronym / sponsor ID
- SoFiT / NL75999.091.21
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Wageningen UniversityUniversity, hospital or other
- Collaborators
- World Cancer Research Fund International, Gelderse Vallei Hospital, Flevoziekenhuis, Slingeland Hospital, Rijnstate Hospital, Het Prospectief Landelijk CRC cohort (PLCRC), Deventer Ziekenhuis
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 25 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two parallel arms: intervention and control.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Behaviour change guided lifestyle interventionThe 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behaviour change guided lifestyle interventionParticipants 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. | Behavioural | Intervention group |
Primary outcome
Change in cancer-related fatigue
Time frame: Baseline till six months
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.
22 secondary outcomes
Cancer-related fatigue
Time frame: Twelve months
Skeletal muscle fat infiltration and muscle circumference
Time frame: Baseline and six months
Gut microbiota composition
Time frame: Baseline and six months
Health-related quality of life
Time frame: Baseline and six months
Physical performance (3-minute step test)
Time frame: Baseline and six months
Physical performance (5 times sit-to-stand test)
Time frame: Baseline and six months
Physical performance (tandem test)
Time frame: Baseline and six months
Physical performance (chair sit-and-reach test)
Time frame: Baseline and six months
Physical performance (strength: hand dynamometer)
Time frame: Baseline and six months
Sleep quality and duration (Pittsburgh Sleep Quality Index)
Time frame: Baseline, six months and 12 months
Sleep quality and duration (Consensus sleep diary morning)
Time frame: Baseline and six months
Depression
Time frame: Baseline and six months
Anxiety
Time frame: Baseline and six months
Behavioural determinants
Time frame: Baseline, three months, six months and twelve months.
Habitual dietary intake (Food Frequency Questionnaire)
Time frame: Baseline, six months and twelve months
Habitual dietary intake (Eetscore)
Time frame: Baseline, three months, six months and twelve months
Physical activity level (Short QUestionnaire to ASsess Health-enhancing physical activity)
Time frame: Baseline, three months, six months and twelve months
Physical activity level (Accelerometer)
Time frame: Baseline and six months
Anthropometric measurements (Height)
Time frame: Baseline and six months
Anthropometric measurements (Weight)
Time frame: Baseline, three months (self-reported) and six months
Anthropometric measurements (Waist circumference)
Time frame: Baseline and six months
Cost-effectiveness evaluation
Time frame: Baseline, three months and six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2025.
- Derived from this study: PubMed 38804183de 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behaviour change guided lifestyle intervention in people with Colorectal Cancer and Cancer-related Fatigue, run by Wageningen University at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cancer-related fatigue (time frame: Baseline till six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05390398, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2025.