Breast Cancer Survivors, Cancer Related Cognitive Impairment
Conditions
Brief summary
This study is a monocentric, observational, cross-sectional study with a case-control design, aimed at evaluating the construct validity, discriminative ability, and diagnostic accuracy of a second-level neuropsychological test battery for the detection of cancer-related cognitive impairment in breast cancer survivors.
Detailed description
Participants will undergo a comprehensive neuropsychological assessment including both paper-and-pencil tests to be validated and their corresponding comparator instruments, in order to evaluate sensitivity, specificity, and convergent validity across multiple cognitive domains.
Interventions
None listed
Sponsors
European Institute of Oncology
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Age between 18 and 65 years old * Patient with a previous documented diagnosis of non-metastatic breast cancer (only for breast cancer survivor gruop) * Patient has completed chemotherapy for at least 6 months and for a maximum of 36 months if planned (only for breast cancer survivor gruop) * Understanding of the Italian language and ability to give informed consent
Exclusion criteria
* Presence of brain metastases or history of brain radiation therapy (only for breast cancer survivor gruop) * Patient with previous diagnosis of other malignant tumors in addition to breast cancer (only for breast cancer survivor gruop) * Patient with a previous diagnosis of malignant carcinomas (only for control gruop) * Patient with a history of brain damage with unresolved neurological consequences * Patient with previous or current serious neurological pathologies * Patient with severe psychiatric conditions * Patient with systemic pathologies that could interfere with cognitive abilities * Patient taking medications that have a strong cognitive impact and that have not been stabilized for at least 4 weeks prior to enrollment * Patient with visual or hearing impairments that are not properly corrected * Patient with any disability that might compromise the validity of cognitive tests
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validation of a second-level cognitive test battery to be employed for clinical use for the detection of CRCI in breast cancer survivors | At enrollment | Overall success rate to assess CRCI in breast cancer survivors compared with already existing tests. |
Countries
Italy
Contacts
CONTACTGabriella Pravettoni, MD, PhD
Outcome results
None listed