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

Study Overview
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Brief Summary
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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.

Detailed Description
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Medical progress in the treatment of cancer has prolonged patients' life expectancy. This improvement has led researchers to become concerned about the long-term negative effects of cancer treatments on quality-of-life. In particular, previous studies have identified complaints that have been submitted concerning the cognitive status of patients treated with chemotherapy (Berglund et coll., 1991). All of these cognitive changes are collectively grouped under the term chemobrain. 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.

Official Title
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Etude e-ONCOGITE : Évaluation d'Une Prise en Charge Cognitive adaptée au  Chemobrain Chez Des Patientes traitées Pour un Cancer de Sein.

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Cognitive remediation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women aged 20 to 60 years inclusive. Localised breast cancer having required neoadjuvant or adjuvant chemotherapy, the last cycle of which took place between 2 and 24 months prior to inclusion. Informed consent dated and signed. 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: Metastatic breast cancer. Presence of unstable psychiatric or neurological disorders likely to affect cognition (information requested directly from the participant) History of drug abuse. Patient who cannot read or understand French. Patient already included in this study. Patient having participated in onCOGITE workshops. Patient participating in another clinical trial evaluating cognitive remediation. Patient deprived of freedom or subject to legal protection measures (under guardianship, in custody of the court, or family-member guardianship order).

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1 (Cognitive remediation)<br> | Behavioral: Cognitive remediation<br>* 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.<br>|
| No Intervention: Group 2 (No cognitive remediation)<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognition