Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Other |
Blood pressure |
Blood pressure is measured using a sphygmomanometer. Both diastolic and systolic blood pressure are measured. |
Baseline and six months |
|
| Other |
Heart rate |
Heart rate is measured using a sphygmomanometer. |
Baseline and six months |
|
| Other |
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 |
|
| Other |
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 |
|
| Other |
Hemoglobin levels |
Finger prick blood sampling is used for assessing haemoglobin status as an indicator for anaemia. |
Baseline and six months |
|
| Other |
Sociodemographic information |
Sociodemographic information is collected using standardized questionnaires. |
Baseline (and six months) |
|
| Other |
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) |
|
| Primary |
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 |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
Physical performance (strength: hand dynamometer) |
This test uses a hand dynamometer to measure strength. |
Baseline and six months |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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. |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
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 |
|
| Secondary |
Anthropometric measurements (Height) |
Height (in cm) is measured with a stadiometer. |
Baseline and six months |
|
| Secondary |
Anthropometric measurements (Weight) |
Weight (in kg) is measured with a calibrated scale. |
Baseline, three months (self-reported) and six months |
|
| Secondary |
Anthropometric measurements (Waist circumference) |
Waist circumference (in cm) is measured using tape measures. |
Baseline and six months |
|
| Secondary |
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 |
|
