The objective of the study is investigate the relationship between adherence to the recommendations for cancer prevention of the WCRF and cancer-related fatigue in colorectal cancer survivors.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
vermoeidheid na dikke darmkanker behandeling.
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
* 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.
Background summary
More people survive colorectal cancer due to improvements in treatments. These
treatments are so far not without side-effects, thus many people who survive
colorectal cancer have these side-effects. Cancer-related fatigue is the most
common and most invasive side-effect that affects colorectal cancer survivors.
Till now, not enough intervention studies has been done on the effect of a
healthy lifestyle, a combination of nutrition and exercise on cancer-related
fatigue in colorectal cancer survivors. Research has been done on de effect of
nutrition or exercise on lowering cancer-related fatigue. These studies found
that exercise can possibly lower cancer-related fatigue, however not enough
evidence has been found on the effect of nutrition on cancer-related fatigue.
With a healthy lifestyle we mean the recommendations on cancer preventie made
by the World Cancer Research Fund. Relationships have been found in cohort
studies on these recommendations and cancer-related fatigue. Following the
recommendations is associated with a decrease in cancer-related fatigue in
colorectal cancer survivors. Furthermore, the intervention studies on
cancer-related fatigue in colorectal cancer survivors didn't select on
cancer-related fatigue before hand and didn't have cancer-related fatigue as
their primary outcome. Therefore we will take cancer-related fatigue as primary
outcome, select on cancer-related fatigue before hand and combine nutrition and
exercise as the intervention program.
For more information please see chapter 1 in the protocol.
Study objective
The objective of the study is investigate the relationship between adherence to
the recommendations for cancer prevention of the WCRF and cancer-related
fatigue in colorectal cancer survivors.
Study design
Participants will be randomised into an intervention or controle group.
Participants in the intervention group will increase their adherence to the
recommendations of the WKOF by following a lifestyle intervention for 6 months.
During these 6 months, they will be guided by a lifestyle coach who will help
them with all the different categories of these recommendations with regards to
nutrition and exercise. The coach will meet the participants every other weeks
to help them improve adherence at home, online or via telephone. Possible
SARS-COVID-19 restrictions will be taken into account, so most of the
intervention will also be made possible online.
Participants in the controle group will get a light version of the intervention
after 6 months, while in the mean time they will act as controle. The light
version consist of the materials of the intervention and two personalized
coaching sessions with the lifestyle coach.
The researchers will do the measurements at baseline and at the end of the
study.
Intervention
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.
Study burden and risks
No risk is expected for participants participation in this study. The lifestyle
intervention will follow the recommendations of cancer prevention of the WCRF.
The intervention will be home-based, which entails that the lifestyle coaches
will visit the participants at home to deliver the intervention. Remaining
contact will take place via telephone and/or e-mail. The included measurements
can be considered mostly non-invasive. Measurements are taken at the homes of
participants and questionnaires can be filled out online.
Benefits for the participants may include a decrease CRF, and thus therefore an
improvement of quality of life.
Stippeneng 4
Wageningen 6708WE
NL
Stippeneng 4
Wageningen 6708WE
NL
Listed location countries
Age
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
* 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75999.091.21 |
| Other | TBA |