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

Sponsor

Institut de Cancérologie de Lorraine (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05538000

Collaborator

(none)

Enrollment

Arm

26.1

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

EFACog is a single-center prospective cohort 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, 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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Other: Face to face and telephonic interviews	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

56 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Evaluation of the Feasibility of Personalized and Preventive Support for Cognitive Impairment by a Paramedic in Women With Non-Metastatic Breast Cancer Receiving Chemotherapy (EFACog)

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Personalized support program	Other: 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

Arm

Intervention/Treatment

Experimental: Personalized support program

Other: 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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18 to 65
WHO 0 to 1
Patient newly diagnosed with breast cancer (unilateral or bilateral)
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
Patients with major cognitive impairment or significant cognitive complaints (according to Montreal Cognitive Assessment and Cognitive Complaint 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Institut de Cancérologie de Lorraine

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Institut de Cancérologie de Lorraine

ClinicalTrials.gov Identifier:

NCT05538000

Other Study ID Numbers:

ICL-2022-1

First Posted:

Sep 13, 2022

Last Update Posted:

Sep 13, 2022

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Breast Neoplasms

Cognitive Dysfunction

Study Results

No Results Posted as of Sep 13, 2022