Clinical trial · Interventional
Evaluation of Cognitive Management for Chemobrain in Patients Treated for Breast Cancer.
Etude e-ONCOGITE : Évaluation d'Une Prise en Charge Cognitive adaptée au " Chemobrain" Chez Des Patientes traitées Pour un Cancer de Sein.
NCT05690828CI-TRIAL-00093574e-ONCOGITEactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cognitive remediation | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1 (Cognitive remediation)
- interventionNames
- Behavioral: Cognitive remediation
- type
- NO_INTERVENTION
- label
- Group 2 (No cognitive remediation)
Primary outcomes (1)
- measure
- Number of participants with improved quality of life (Emotional and functional QoL)
- timeFrame
- 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method
- description
- 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).
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 60 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.