Breast Cancer Clinical Trial
— e-ONCOGITEOfficial title:
Etude e-ONCOGITE : Évaluation d'Une Prise en Charge Cognitive adaptée au " Chemobrain" Chez Des Patientes traitées Pour un Cancer de Sein.
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.
Status | Recruiting |
Enrollment | 164 |
Est. completion date | December 1, 2024 |
Est. primary completion date | June 1, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 60 Years |
Eligibility | 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). |
Country | Name | City | State |
---|---|---|---|
France | Institut Bergonié, Comprehensive Cancer Center | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
Institut Bergonié | Association Oncogite, University of Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with improved quality of life (Emotional and functional QoL) | 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). | 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method | |
Secondary | Number of participants with improved quality of life (physical QoL) | Improved QoL is defined as a significant improvement (i.e. at least a 3-point increase of the total score) in the physical Well-Being subscale of the FACT-B self-questionnaire (Functional Assessment of Cancer Therapy -Breast - Brady et al. J Clin Oncol 1997). | 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method | |
Secondary | Number of participants with improved quality of life (Social/family QoL) | Improved QoL is defined as a significant improvement (i.e. at least a 3-point increase of the total score) in the Social/family subscale of the FACT-B self-questionnaire (Functional Assessment of Cancer Therapy -Breast - Brady et al. J Clin Oncol 1997). | 4 months after initiation of the cognitive stimulation protocol using the "onCOGITE" method |
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