The primary aim of the study is to identify breast cancer patients who experience objective and/ or subjective cognitive dysfunction one year after chemotherapy and find determinants of this cognitive dysfunction on patients' quality of life…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters: subjective cognitive dysfunction, objective cognitive
dysfunction
Outcome of the study: quality of life, health care consumption
Secondary outcome
N.A.
Background summary
It concerns a widely set up research at women with breast cancer treated with
chemotherapy. Cognitive dysfunction as side effect of chemotherapy is a long
lasting and underestimated problem.
Study objective
The primary aim of the study is to identify breast cancer patients who
experience objective and/ or subjective cognitive dysfunction one year after
chemotherapy and find determinants of this cognitive dysfunction on patients'
quality of life and health care consumption.
Study design
We want to include at least 300 women in the study (breast cancer and benign)
during a periosd of one year.
Women with a benign diagnosis will be included as comparison group.
Neuropsychological tests will be done three times (before chemotherapy, 3 and
12 months after chemotherapy); at the same moments questionnaires will be
completed.
Patients with a benign diagnosis (only in the St. Elisabeth hospital, Tilburg)
get also neuropsychological tests and completed questionnaires after diagnosis
and 3 and 12 months after diagnosis.
Study burden and risks
N.A.
Postbus 90153
5000 LE Tilburg
NL
Postbus 90153
5000 LE Tilburg
NL
Listed location countries
Age
Inclusion criteria
Women visiting the outpatieny clinics with a suspicion of breast cancer
Exclusion criteria
disease recurrence at baseline or metastases; history of neuropsychologic and/ or psychiatric signs or symptoms that lead to deviant neuropsychologic test results (e.g. dementia); the use of medication that may lead to deviant neuropsychological results; alcohol and drug addiction; poor expression in the dutch language
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 | NL21576.008.08 |