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Active, not recruiting Not applicable

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

NCT05538000 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-08-01
Last updated
2026-10-22

Condition(s) studied

No Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

Face to face and telephonic interviews

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • To assess program feasibility — 9 months
    Rate of patients who participated in all provider interviews (face-to-face and telephone contacts).

Trial sites (1)

FacilityCityRegionStatus
Institut de Cancérologie de Lorraine Vandœuvre-lès-Nancy Vandoeuvres Les Nancy
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05538000 on ClinicalTrials.gov ↗ ← All trials in France