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

NCT ID: NCT05538000

Last Updated: 2025-11-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2027-06-17

Brief Summary

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.

Conditions

No Metastatic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Personalized support program

Group Type: EXPERIMENTAL

Face to face and telephonic interviews

Intervention Type: OTHER

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.

Interventions

Face to face and telephonic interviews

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut de Cancérologie de Lorraine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

LIONEL UWER, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Vandoeuvres Les Nancy, France

Countries

France

Other Identifiers

ICL-2022-1

Identifier Type: -

Identifier Source: org_study_id