EFACog protocol: a single-center feasibility study of a preventive, personalized cognitive support program delivered by paramedical caregivers to women receiving chemotherapy for non-metastatic breast cancer

Abstract

Abstract Background Cancer-related cognitive complaints affect up to 75% of women treated with chemotherapy for breast cancer, undermining quality of life and delaying return to work. Current support programs are typically reactive and delivered outside routine oncology pathways, which limits patient access and long-term adherence. EFACog is a single-center feasibility study that embeds a personalized cognitive support intervention directly into the standard course of chemotherapy, with the aim of preventing or attenuating cognitive symptoms before they arise. Methods Fifty women (18–65 years) with newly diagnosed, non-metastatic breast cancer scheduled for (neo)adjuvant chemotherapy will be screened with the Montreal Cognitive Assessment (MoCA) and the Cognitive Complaint Questionnaire (QPC) to exclude objective or self-reported impairment (MoCA ≥ 26/30, QPC < 3). Each participant will then follow a 9-month program fully integrated into routine care: four 1-h face-to-face consultations (baseline, months 3, 6, 9) are scheduled to coincide with regular oncology visits, and six brief telephone contacts (months 1, 2, 4, 5, 7, 8) are arranged during normal clinic hours. A trained paramedical caregiver and the patient co-create an individual cognitive stimulation plan based on personal interests (e.g., reading, gardening, brain games) and available time. Follow-up sessions reassess cognitive complaints (FACT-Cog), quality of life (EORTC QLQ-C30), fatigue (QLQ-FA12), anxiety and depression (HADS), and adherence to the plan. The primary endpoint is program adherence—completion of all ten scheduled contacts—which will indicate whether a preventive cognitive intervention can be maintained within busy oncology workflows. Secondary endpoints, analyzed in an exploratory manner, include longitudinal changes in patient-reported outcomes, incidence of new neurocognitive impairment at month 9 (MoCA and QPC), and patient satisfaction. Discussion By embedding the intervention entirely within existing appointments and relying on paramedical staff already present in the care team, EFACog will test the operational feasibility of delivering early cognitive support without adding extra clinic visits or specialist referrals. Feasibility metrics on recruitment, scheduling, staffing, and adherence will inform the design of a future multicenter randomized controlled trial and will provide a template for scalable integration of cognitive care into standard oncology pathways. Trial registration Registered at ClinicalTrials.gov: NCT05538000. French national identifier: ID-RCB 2024-A00290-47. Protocol version 1.1 dated 03 May 2024. Sponsor: Institut de Cancérologie de Lorraine; Vandœuvre-lès-Nancy, France.