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NCT Number: NCT05538000

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

No Metastatic Breast Cancer

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, Vandoeuvres Les Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Face to face and telephonic interviews

Other

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 outcomes

  1. To assess program feasibility

    Time frame: 9 months

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

Secondary outcomes

  1. The cognitive complaint

    Time frame: 9 months

    The cognitive complaint will be assessed by the FACT-Cog questionnaire comprising 37 items.

  2. The Quality of life of patients

    Time frame: 9 months

    Quality of life will be assessed by the generic QLQ-C30 questionnaire of 30 items.

  3. Fatigue

    Time frame: 9 months

    Fatigue will be assessed by the QLQ-FA12 questionnaire of 12 items.

  4. Anxiety and depression

    Time frame: 9 months

    Anxiety/depression will be assessed by the 14-item HADS questionnaire (7 items: anxiety / 7 items: depression).

  5. Appearance of neurocognitive disorders and/or significant cognitive complaints

    Time frame: 9 months

    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.

  6. Satisfaction of patients

    Time frame: 9 months

    Satisfaction will be assessed by a numerical scale (0: not satisfied to 10: very satisfied).

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Official study 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).

Acronym: EFACog

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Sep 13, 2022
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.