Clinical trial NCT05538000: Personalized Preventive Support for Cognitive Impairment in Non-Metastatic Breast Cancer (EFACog)
Official title: 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).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: No Metastatic Breast Cancer
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: To assess program feasibility
timeFrame: 9 months
Secondary outcomes:
measure: The cognitive complaint
timeFrame: 9 months
measure: The Quality of life of patients
timeFrame: 9 months
measure: Fatigue
timeFrame: 9 months
measure: Anxiety and depression
timeFrame: 9 months
measure: Appearance of neurocognitive disorders and/or significant cognitive complaints
timeFrame: 9 months
measure: Satisfaction of patients
timeFrame: 9 months
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Institut de Cancérologie de Lorraine
state: Vandoeuvres Les Nancy
Study officials:
References: