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

Primary Purpose

Breast Cancer

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Face to face and telephonic interviews

About this trial

This is an interventional supportive care trial for Breast Cancer

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Personalized support program

Arm Description

Outcomes

Primary Outcome Measures

To assess program feasibility

Rate of patients who participated in all provider interviews (face-to-face and telephone contacts).

Secondary Outcome Measures

Full Information

NCT ID

NCT05538000

First Posted

September 8, 2022

Last Updated

September 26, 2023

Sponsor

Institut de Cancérologie de Lorraine

1. Study Identification

Unique Protocol Identification Number

NCT05538000

Brief Title

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

Acronym

EFACog

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)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 2024 (Anticipated)

Primary Completion Date

September 2026 (Anticipated)

Study Completion Date

September 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Institut de Cancérologie de Lorraine

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Personalized support program

Arm Type

Experimental

Intervention Type

Other

Intervention Name(s)

Face to face and telephonic interviews

Intervention Description

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

Primary Outcome Measure Information:

Title

To assess program feasibility

Description

Rate of patients who participated in all provider interviews (face-to-face and telephone contacts).

Time Frame

9 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

MERLIN JEAN LOUIS, PharmD, PhD

Phone

+ 33 3 83 65 60 62

jl.merlin@nancy.unicancer.fr

First Name & Middle Initial & Last Name or Official Title & Degree

HERMAN MARIE AUDE

Phone

+33 3 83 59 86 68

m.herman@nancy.unicancer.fr

12. IPD Sharing Statement

Learn more about this trial

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

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