Evaluation of Cognitive Management for Chemobrain in Patients Treated for Breast Cancer.
NCT ID: NCT05690828
Last Updated: 2025-08-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
164 participants
INTERVENTIONAL
2023-02-01
2026-03-31
Brief Summary
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Detailed Description
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The consequences of treatments remain however underestimated, as the priority when diagnosing cancer remains the patient's short- to medium-term survival; yet, quality-of-life contributes to the long-term survival of patients (Kramer, 2000).
In addition to medical treatments, psychosocial care adapted to the specific needs of subjects is thus important for improving their quality-of-life and helping them return to work. Even if initiatives have multiplied over the past few decades in the psychosocial management of these subjects (e.g., supportive care), that related to cognitive disorders in subjects having survived cancer remains a little documented field. Cognitive deficiency in cancer survivors is said to be moderate (Razaq et coll., 2017), which makes survivors ideal candidates for cognitive rehabilitation.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Group 1 (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.
Group 2 (No cognitive remediation)
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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).
20 Years
60 Years
FEMALE
No
Sponsors
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University of Bordeaux
OTHER
Association Oncogite
UNKNOWN
Institut Bergonié
OTHER
Responsible Party
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Principal Investigators
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Locations
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Institut Bergonié, Comprehensive Cancer Center
Bordeaux, , France
Countries
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Other Identifiers
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IB2022-04
Identifier Type: -
Identifier Source: org_study_id
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