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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; Rectal Cancer; Colon Cancer; Cancer-related Fatigue
• Intervention / Treatment: Behavioral: Behaviour change guided lifestyle intervention

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 Type: Interventional
• Enrollment (Estimated): 184
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Gelderland
    • Wageningen, Gelderland, Netherlands, 6708WE
      • Wageningen University & Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; 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.
No Intervention: Wait-list usual care group; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	Baseline and six months
Physical performance (strength: hand dynamometer)	This test uses a hand dynamometer to measure strength.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Baseline and six months
Anthropometric measurements (Height)	Height (in cm) is measured with a stadiometer.	Baseline and six months
Anthropometric measurements (Weight)	Weight (in kg) is measured with a calibrated scale.	Baseline, three months (self-reported) and six months
Anthropometric measurements (Waist circumference)	Waist circumference (in cm) is measured using tape measures.	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.	Baseline, three months and six months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood pressure	Blood pressure is measured using a sphygmomanometer. Both diastolic and systolic blood pressure are measured.	Baseline and six months
Heart rate	Heart rate is measured using a sphygmomanometer.	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).	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.	Baseline and six months
Hemoglobin levels	Finger prick blood sampling is used for assessing haemoglobin status as an indicator for anaemia.	Baseline and six months
Sociodemographic information	Sociodemographic information is collected using standardized questionnaires.	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).	Baseline (and six months)

Collaborators and Investigators

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

Publications and helpful links

Helpful Links

• Information about the SoFiT study

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 24, 2022
• First Submitted That Met QC Criteria: May 19, 2022
• First Posted (Actual): May 25, 2022

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Nutrition; Physical activity; Lifestyle; Behaviour change; Cancer-related fatigue; Colorectal cancer survivors; Intervention study; Lifestyle coach; Skeletal muscle fat infiltration
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Fatigue; Colorectal Neoplasms
• Other Study ID Numbers: NL75999.091.21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No