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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: No Metastatic Breast Cancer
• Intervention / Treatment: Other: Face to face and telephonic interviews

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MERLIN JEAN LOUIS, PharmD, PhD; Phone Number: + 33 3 83 65 60 62; Email: jl.merlin@nancy.unicancer.fr
• Study Contact Backup: Name: BOUJEDAINI NAOUAL, PhD.; Phone Number: +33 3 83 59 86 68; Email: n.boujedaini@nancy.unicancer.fr

Study Locations

• France
  • Alabama
    • Vandœuvre-lès-Nancy, Alabama, France, 54500
      • Institut de Cancérologie de Lorraine
      • Contact: Lionel UWER, MD; Phone Number: +33 3 83 59 84 61; Email: l.uwer@nancy.unicancer.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess program feasibility	Rate of patients who participated in all provider interviews (face-to-face and telephone contacts).	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The cognitive complaint	The cognitive complaint will be assessed by the FACT-Cog questionnaire comprising 37 items.	9 months
The Quality of life of patients	Quality of life will be assessed by the generic QLQ-C30 questionnaire of 30 items.	9 months
Fatigue	Fatigue will be assessed by the QLQ-FA12 questionnaire of 12 items.	9 months
Anxiety and depression	Anxiety/depression will be assessed by the 14-item HADS questionnaire (7 items: anxiety / 7 items: depression).	9 months
Appearance of neurocognitive disorders and/or significant cognitive complaints	The appearance of neurocognitive disorders and/or significant cognitive complaints will be assessed by taking the MoCA (Montreal Cognitive Assessment) and QPC (Semi-structured Cognitive Complaint Questionnaire) tests.	9 months
Satisfaction of patients	Satisfaction will be assessed by a numerical scale (0: not satisfied to 10: very satisfied).	9 months

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2027

Study Registration Dates

• First Submitted: September 8, 2022
• First Submitted That Met QC Criteria: September 8, 2022
• First Posted (Actual): September 13, 2022

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 4, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ICL-2022-1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No