NCT05538000Active, not recruiting
Personalized Preventive Support for Cognitive Impairment in Non-Metastatic Breast Cancer (EFACog)
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).
Source: ClinicalTrials.gov · Last updated 22 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 8 Sept 2022
- Start date
- 1 Aug 2024
- Primary completion date
- 20 Aug 2026
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Diseases
- Metastatic breast cancer
- NCT number
- NCT05538000
What you commit to
- Study type: Interventional
- Participants enrolled: 50
- From 1 Aug 2024 to the primary completion date, 20 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient with a cancer concomitant with breast cancer and/or metastatic breast cancer;
- Patients with previous or ongoing carcinological treatment;
Other illness
- 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);
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut de Cancérologie de Lorraine Coordinator of this site? Confirm its status | Vandœuvre-lès-Nancy | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.