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

Institut de Cancérologie de Lorraine

Status: Active, not recruiting

Conditions: No Metastatic Breast Cancer

Treatments: Other: Face to face and telephonic interviews

Study type: Interventional

Funder types: Other

Identifiers

NCT05538000

ICL-2022-1

Details and patient eligibility

About

EFACog is a single-center prospective cohort feasibility 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. The objective of this support program is 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.

Enrollment: 50 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 65;
• WHO 0 to 1;
• Patient newly diagnosed with breast cancer (unilateral or bilateral);
• Patient with a MoCA score not revealing proven cognitive disorders (MoCA ≥ 26/30 and a QPC score <3, without a "YES" answer to question 5 and without 2 "YES" answers to questions A, 4, 5, 7, 8 of the questionnaire);
• 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;
• Patient with a major cognitive disorder or a significant cognitive complaint (according to MoCA < 26/30 and QPC >3 with "YES" answer to question 5 and with 2 "YES" answers to questions A, 4, 5, 7, 8 of the 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;
• Man.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Personalized support program

Experimental group

Treatment:

Other: Face to face and telephonic interviews