PAM study
- Conditions
- Breast cancer, cognitive problems, borstkanker, cognitieve problemen
- Registration Number
- NL-OMON21029
- Lead Sponsor
- niversity Medical Center Utrecht (UMCU)
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 180
cancer patients adjuvantly treated with chemotherapy with or without endocrine therapy, 2-4 years after cancer diagnosis, 30-75 years of age, no indication of relapse or metastases, exercise ¡Ü 150 min/week,
self-reported cognitive problems, lower than expected performance on neuropsychological testing, mastering the Dutch language and willing to be randomly assigned to one of the two study arms.
We will exclude patients with known neurological conditions and/or diseases that affect cognition (e.g. dementia, MS, TBI), disorders that might impede exercise participation, contra indications for MR imaging, treated for breast cancer in both breasts; and patients switching from Tamoxifen to aromatase inhibitors during the study period or four months before
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary outcome parameters are: cognitive functioning (the total recall score of the HVLT-R as our primary outcome measure) and self-reported cognitive complaints (MDASI-MM module, 2 symptom severity questions on memory and attention and 6 symptom interference items). <br>
- Secondary Outcome Measures
Name Time Method Secondary parameters include overall cognitive functioning measured by standard neuropsychological tests, brain structure and function (3 Tesla brain MRI), anthropometrics, physical fitness, QOL, fatigue, anxiety and depressive symptoms, and work performance. <br>