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

NCT05538000 | Active Not Recruiting

• 1 other identifier: ICL-2022-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• To assess program feasibility

  Rate of patients who participated in all provider interviews (face-to-face and telephone contacts).

  9 months

Secondary Outcomes (6)

• The cognitive complaint

  9 months

• The Quality of life of patients

  9 months

• Fatigue

  9 months

• Anxiety and depression

  9 months

• Appearance of neurocognitive disorders and/or significant cognitive complaints

  9 months

Study Arms (1)

Personalized support program

EXPERIMENTAL

Other: Face to face and telephonic interviews

Interventions

Face to face and telephonic interviews 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.

Personalized support program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut de Cancérologie de Lorraine: lead

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Vandoeuvres Les Nancy, 54500, France

Location

Study Officials

• LIONEL UWER, MD

  Institut de Cancérologie de Lorraine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2022
• First Posted: September 13, 2022
• Study Start: August 1, 2024
• Primary Completion (Estimated): June 17, 2026
• Study Completion (Estimated): June 17, 2027
• Last Updated: November 28, 2025

Record last verified: 2025-11

Locations

FR (1)