vermoeidheid na dikke darmkanker behandeling. fatigue
Conditions
Interventions
A lifestyle intervention in which participants will increase their adherence to
the recommendations for cancer prevention of the World Cancer Research Fund
compared to baseline.
Sponsors
Wageningen Universiteit
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Aged 18 or above * Completed curative stage I-III colorectal cancer treatment 6 months to 5 years ago * 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
Exclusion criteria: * Planning to participate or participating in another medical research that could possibly interfere with the study results. * Excessive alcohol consumption (i.e. on average more than 4 glasses of alcohol 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is cancer-related fatigue measured via the FACIT-F questionnaire. The FACIT-F is a specialised questionnaire made to score fatigue in chronic illnesses. The FACIT-F is an abbreviation of Functional Assessment of Chronic Illness Therapy - Fatigue. | — |
Secondary
| Measure | Time frame |
|---|---|
| * Investigate (I) whether the changes in the following parameters are associated with changes in CRF and (II) whether the changes in those parameters differ between the intervention group and the wait-list control group o Skeletal muscle fat infiltration and cross-sectional area in the m. rectus femoris, lateral gastrocnemius and biceps brachialis o Gut microbiota composition o HRQoL o Physical performance o Sleep quality and duration o Depression and anxiety. * To investigate whether differences in CRF between the intervention and control group can be attributed to changes in behavioural determinants. * Process evaluation o To investigate adherence of participants to the WCRF cancer prevention guidelines. o To investigate the cost-effectiveness of the SoFiT trial. o To investigate the relation between the level of adherence of participants to the WCRF cancer prevention guidelines and its effect on CRF. o To investigate the experience of participants and relevant stakeholders on the SoFiT intervention. * To investigate the prolonged effect of the lifestyle intervention on CRF and behaviour change, six months after completion of the intervention on CRF. | — |
Countries
Netherlands
Outcome results
None listed