Personalized support program to prevent cognitive impairment in breast cancer patients
Evaluation of the Feasibility of Personalized and Preventive Support for COGnitive Complaints, by a Paramedical Caregiver in Women Suffering From Non-Metastatic Breast Cancer, Requiring Chemotherapy (EFACog).
This study is testing a personalized support program for women with non-metastatic breast cancer to see if it can help prevent memory and thinking problems after chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Institut de Cancérologie de Lorraine Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Vandœuvre-lès-Nancy, Vandoeuvres Les Nancy) |
| Trial ID | NCT05538000 on ClinicalTrials.gov |
What this trial studies
EFACog is a prospective cohort feasibility study aimed at evaluating a personalized support program for patients with non-metastatic breast cancer. The program, conducted by a nurse over a period of 9 months, includes both face-to-face and telephone interviews to monitor and support patients after their first course of chemotherapy. The study focuses on patients who do not have pre-existing cognitive impairment, with the goal of preventing post-chemotherapy cognitive issues. Follow-up visits are coordinated with routine care appointments to ensure comprehensive support.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 who are newly diagnosed with unilateral or bilateral non-metastatic breast cancer and have no significant cognitive disorders.
Not a fit: Patients with metastatic breast cancer, major cognitive disorders, or those undergoing other cancer treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly reduce the risk of cognitive impairment in breast cancer patients undergoing chemotherapy.
How similar studies have performed: While this approach is innovative, similar studies focusing on cognitive support in cancer patients have shown promising results, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Vandœuvre-lès-Nancy, Vandoeuvres Les Nancy
- Institut de Cancérologie de Lorraine — Vandœuvre-lès-Nancy, Vandoeuvres Les Nancy, France (Recruiting)
Study contacts
- Study coordinator: MERLIN JEAN LOUIS, PharmD, PhD
- Email: jl.merlin@nancy.unicancer.fr
- Phone: + 33 3 83 65 60 62
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.