Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| No Metastatic Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Face to face and telephonic interviews | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Personalized support program
- interventionNames
- Other: Face to face and telephonic interviews
Primary outcomes (1)
- measure
- To assess program feasibility
- timeFrame
- 9 months
- description
- Rate of patients who participated in all provider interviews (face-to-face and telephone contacts).
Secondary outcomes (6)
- measure
- The cognitive complaint
- timeFrame
- 9 months
- description
- The cognitive complaint will be assessed by the FACT-Cog questionnaire comprising 37 items.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available