This study aims to investigate whether mijnfittebrein.nl has a positive effect on cognition in cancer patients after chemotherapy treatment, compared to treatment as usual.
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Feasibility study:
Compliance rate of the participants after 3 months, if there is a compliance of
more than 50% after 3 months and the feedback from the structured interview is
mostly positive we will continue with the main study.
Main study:
The change in subjective cognitive functioning between baseline and 6 months
later, comparing the effect of MFB to no intervention.
Secondary outcome
Feasibility study:
Usability
Areas of improvement
Main study:
The change in objective cognitive functioning between baseline and 6 months.
The change in lifestyle functions between baseline and 6 months.
The influence of other parameters such as level of education, work performance,
self-efficacy, type of cancer, type of treatment, age, gender, psychological
functioning on the effect of the intervention.
Background summary
In cancer survivors, cognitive dysfunction is one of the most problematic
long-term sequelae of treatment. Although cognitive side effects are most
prevalent during treatment, in some cases they continue to exist long after
treatment cessation. Cognitive problems not only often lead to difficulties in
keeping up with social- and work demands, but they are also associated with
decrements in health-related quality of life. These difficulties show the need
for interventions targeted at improving cognition in cancer patients. The
present study will investigate the effect of a self-motivated online lifestyle
intervention, mijnfittebrein.nl (MFB) on cognition in cancer patients. If MFB
is effective in improving cognition in cancer patients, it could be used by
more survivors who encounter cognitive difficulties after cancer treatment.
Study objective
This study aims to investigate whether mijnfittebrein.nl has a positive effect
on cognition in cancer patients after chemotherapy treatment, compared to
treatment as usual.
Study design
The first part of the study consists of a feasibility study to research whether
the intervention is suited for this population of cancer survivors. The
feasibility study will use only an intervention group.The main study will be
designed as a randomized controlled trial.
Intervention
Mijnfittebrein.nl (MFB) will be the intervention used in the study. MFB has
originally been developed by Radboud University Nijmegen under the name Brain
Aging Monitor, to improve cognitive functioning in a healthy older working
population. The intervention had a positive effect on both cognitive
functioning and lifestyle factors.
MFB is a self-motivated online intervention. Patients first fill in multiple
lifestyle questionnaires. The questionnaires focus on lifestyle domains related
to cognitive functioning. Patients receive personalised feedback on their
answers for each lifestyle domain. Based on the feedback they can set a goal
using the GAS method. Progress towards the goal can be tracked on the website
and after a month the goal is evaluated. Multiple resources are available on
the MFB website to support patients in reaching their goals such as blogs,
recipes and a knowledge database.
Study burden and risks
Patients in the intervention condition will use MFB for three (feasibility
study) or six (main study) months, both groups fill in questionnaires and
undergo neuropsychological testing at baseline and after 3 or 6 months. The
study might confront patients with their cognitive problems and physical
health, however the patient burden is expected to be minimal. To our knowledge,
there are no risks associated with participation and patients* cognition and
physical health could benefit from using MFB.
De Boelelaan 1117
Amsterdam 1081 HV
NL
De Boelelaan 1117
Amsterdam 1081 HV
NL
Listed location countries
Age
Inclusion criteria
* Having received chemotherapy treatment for any recently diagnosed non-CNS
cancer
* Chemotherapy treatment has been completed
* Presence of cognitive complaints
* ><= 18 years of age
* Written informed consent
Exclusion criteria
* Primary or secondary brain tumours
* Insufficient mastery of the Dutch language
* History of brain injury with loss of consciousness
* History of brain surgery
* Currently under active treatment for psychiatric disorders
* Neurodegenerative disorders
* Self-reported substance abuse
* Severe visual impairments
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 | NL64033.029.18 |