Cognitive Impairment Assessment in Breast Cancer Survivors

Validation of Neuropsychological Tests for the Assessment of Cognitive Impairment in Breast Cancer Survivors

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Survivors; Cancer Related Cognitive Impairment

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Gabriella Pravettoni, MD, PhD; Phone Number: +39 0257489731; Email: gabriella.pravettoni@ieo.it

Study Locations

• Italy
  • Milan, Italy, 20435
    • European Institute of Oncology
    • Contact: Gabriella Pravettoni, MD, PhD; Phone Number: +39 0257489731; Email: gabriella.pravettoni@ieo.it
    • Principal Investigator: Gabriella Pravettoni, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Female breast cancer survivors (N = 100) will be recruited at the European Institute of Oncology (IEO) while, female non-cancer controls (N = 100) will be recruited though an invitation to participate in the study, accompanied by a brief description of its objectives and procedures, that will be disseminated via social media groups, word of mouth and breast cancer patient associations.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Breast cancer survivors; Female breast cancer survivors
Non-cancer control; Female without any history of cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validation of a second-level cognitive test battery to be employed for clinical use for the detection of CRCI in breast cancer survivors	Overall success rate to assess CRCI in breast cancer survivors compared with already existing tests.	At enrollment

Collaborators and Investigators

• Sponsor: European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 6, 2026
• First Posted (Actual): May 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: UIS 5283; L2-589 (Other Identifier: Comitato Etico Territoriale Lombardia 2)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No