Personalized Preventive Support for Cognitive Impairment in Non-Metastatic Breast Cancer (EFACog)

Study Overview
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Brief Summary
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EFACog is a single-center prospective cohort study conducted on a single group of patients to study the feasibility of a personalized support program by a nurse conducted over 9 months, using face-to-face and telephone interviews, to prevent the occurrence of post-chemotherapy cognitive impairment. After a pre-inclusion visit, patients with no pre-existing cognitive impairment will be included in the study and will receive a 9-month follow-up after the first course of chemotherapy. All follow-up visits (telephone or face-to-face) will be scheduled in conjunction with those taking place in the care setting.

Official Title
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Evaluation of the Feasibility of Personalized and Preventive Support for Cognitive Impairment by a Paramedic in Women With Non-Metastatic Breast Cancer Receiving Chemotherapy (EFACog)

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Face to face and telephonic interviews


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 65 WHO 0 to 1 Patient newly diagnosed with breast cancer (unilateral or bilateral) Patient to receive adjuvant or neo-adjuvant chemotherapy Patient having understood, signed and dated the consent form Affiliated to a social security system Exclusion Criteria: Patient with a cancer concomitant with breast cancer and/or metastatic breast cancer Patients with previous or ongoing carcinological treatment Patients with major cognitive impairment or significant cognitive complaints (according to Montreal Cognitive Assessment and Cognitive Complaint Questionnaire) or neurological sequelae (epilepsy or neurodegenerative disease) Patients who are hearing impaired, visually impaired, or unable to read or speak French Patient deprived of liberty (including curatorship and guardianship) Pregnant woman

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized support program<br> | Other: Face to face and telephonic interviews<br>* face to face interview : before the first chemotherapy treatment (M0), then at 3 months (M3), 6 months (M6) and 9 months (M9) after the first chemotherapy treatment telephonic interview : every month between two face-to-face interviews, i.e. at 1 month after the first treatment (M1), at 2 months (M2), at 4 months (M4), at 5 months (M5), at 7 months (M7) and at 8 months (M8) after the first chemotherapy treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess program feasibility | Rate of patients who participated in all provider interviews (face-to-face and telephone contacts). | 9 months |