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Clinical Trials in France / NCT05690828
Active, not recruiting Not applicable

Evaluation of Cognitive Management for Chemobrain in Patients Treated for Breast Cancer.

NCT05690828 · tracked via the Priya Life Science France tracker
Sponsor
Institut Bergonié
Phase
Not applicable
Started
2023-02-01
Last updated
2025-08-13

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Cognitive remediation

Cognitive remediation: The cognitive remediation programme shall be run either in video workshops or face to face workshops and in home sessions via a web app. The programme will run for 4 months during which there will be 3 different evaluations. A first evaluation after randomisation, a second evaluation 4 months after inclusion (corresponding to the end of the programme), and a third evaluation 8 months after inclusion for the experimental group (4 months after the end of the programme). The face to face workshops will take 8 to 10 participants and will be led by a neuropsychologist.

Study summary

This project will investigate the efficacy of a cognitive remediation programme in patients treated for breast cancer. patients will be randomized between "no intervention" and "intervention programme". Efficay will be assessed in term of improved quality of life.

Eligibility

Sex
FEMALE
Min age
20 Years
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: 1. Women aged 20 to 60 years inclusive. 2. Localised breast cancer having required neoadjuvant or adjuvant chemotherapy, the last cycle of which took place between 2 and 24 months prior to inclusion. 3. Informed consent dated and signed. 4. Patient with French social security cover in accordance with French law on biomedical research (Article 1121-11 of the French code of public health). Exclusion Criteria: 1. Metastatic breast cancer. 2. Presence of unstable psychiatric or neurological disorders likely to affect cognition (information requested directly from the participant) 3. History of drug abuse. 4. Patient who cannot read or understand French. 5. Patient already included in this study. 6. Patient having participated in onCOGITE workshops. 7. Patient participating in another clinical trial evaluating cognitive remediation. 8. Patient deprived of freedom or subject to legal protection measures (under guardianship, in custody of the court, or family-member guardianship order).

Primary outcome measure(s)

  • Number of participants with improved quality of life (Emotional and functional QoL) — 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method
    Improved QoL is defined as a significant improvement (i.e. at least a 3-point increase of the total score) in both the Emotional Well-Being (EWB) and Functional Well-Being (FWB) subscales of the FACT-B self-questionnaire (Functional Assessment of Cancer Therapy -Breast - Brady et al. J Clin Oncol 1997).

Trial sites (1)

FacilityCityRegionStatus
Institut Bergonié, Comprehensive Cancer Center Bordeaux France

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Other trials for the same condition

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Impact of the Intraoperative Use of Amines in Breast Cancer Surgery on Tumor Recurrence Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05690828 on ClinicalTrials.gov ↗ ← All trials in France