It is expected that the use of the MFB intervention will improve subjective cognitive functioning.
ID
Bron
Verkorte titel
Aandoening
Non CNS cancers
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Subjective cognitive functioning
Achtergrond van het onderzoek
Rationale:
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, Mijn Fitte Brein (MFB) on cognition in cancer patients. Previous research has shown that MFB increased cognitive functioning in employed healthy adults. When MFB is effective in improving cognition in cancer patients returning to work, it could be used by more survivors who encounter cognitive difficulties after cancer treatment.
Objective: The objective of the study is to investigate whether the use of MFB will improve cognitive functioning in cancer patients who are returning to work, when compared to patients who receive care as usual.
Study design: randomised controlled intervention study.
Study population: adult (18+) cancer patients who are returning to work after treatment for cancer.
Intervention (if applicable): The experimental group will use MFB for six months. The control group will receive care as usual.
Main study parameters/endpoints: The main study parameter is the change in cognitive functioning between baseline and 6 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients in the intervention condition will use MFB for six months, both groups fill in questionnaires and undergo neuropsychological testing at baseline and after 3 (feasibility study) or 6 (main study) 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.
Doel van het onderzoek
It is expected that the use of the MFB intervention will improve subjective cognitive functioning.
Onderzoeksopzet
baseline, 3 months, 6 months
Onderzoeksproduct en/of interventie
Mijn Fitte Brein online lifestyle intervention
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• Be employed
• Primary treatment has been completed
• Presence of cognitive complaints
• >= 18 years of age
• Written informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
A potential subject who meets any of the following criteria will be excluded from participation in this study:
• 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
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8407 |
| Ander register | METC VUmc : 2018.491 |