Study on Fatigue in Colorectal Cancer Survivors, a Lifestyle Intervention

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.

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.

Echo intensity of the skeletal muscle rectus femoris, lateral gastrocnemius and biceps brachialis is measured using a portable ultrasound machine.

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.

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.

This test indicates cardiovascular fitness by heart rate measurement for one minute after the completion of three minutes of stepping.

This test indicates lower extremity skeletal muscle strength. The time necessary to achieve the standing position on the 5th repetition is measured.

This test measures balance for three different standing positions. Each position has to be maintained for 10 seconds in order to pass the 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.

This test uses a hand dynamometer to measure strength.

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.

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.

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.

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.

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.

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.

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.

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.

Physical activity is also measured using ActivPalTM Micro3, an accelerometer measuring sedentary behaviour and physical activity. The ActivPalTM is worn for 9 days.

Height (in cm) is measured with a stadiometer.

Weight (in kg) is measured with a calibrated scale.

Waist circumference (in cm) is measured using tape measures.

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.

Blood pressure is measured using a sphygmomanometer. Both diastolic and systolic blood pressure are measured.

Heart rate is measured using a sphygmomanometer.

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).

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.

Finger prick blood sampling is used for assessing haemoglobin status as an indicator for anaemia.

Sociodemographic information is collected using standardized questionnaires.

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).