CClinicalTrials.gg
Active, not recruitingNCT05538000EFACogUpdated Sep 1, 2026

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

An interventional study of Face to face and telephonic interviews in No Metastatic Breast Cancer, sponsored by Institut de Cancérologie de Lorraine. Active, not recruiting at 1 site in France. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-01.

Sponsored by Institut de Cancérologie de Lorraine · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • No Metastatic Breast Cancer
03

In context

Lead sponsor

Institut de Cancérologie de Lorraine is the lead sponsor of 62 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • Experimental
    Personalized support program

    Other: Face to face and telephonic interviews

Interventions

  • OtherFace 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.

06

What researchers measure

Primary outcomes

  1. To assess program feasibility

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

    Time frame: 9 months

Secondary outcomes

  1. The cognitive complaint

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

    Time frame: 9 months

  2. The Quality of life of patients

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

    Time frame: 9 months

  3. Fatigue

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

    Time frame: 9 months

  4. Anxiety and depression

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

    Time frame: 9 months

  5. 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.

    Time frame: 9 months

  6. Satisfaction of patients

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

    Time frame: 9 months

07

Study locations

1 site
  • Institut de Cancérologie de Lorraine
    Vandœuvre-lès-Nancy, Vandoeuvres Les Nancy 54500, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05538000
Lead sponsor
Institut de Cancérologie de Lorraine
Responsible party
Sponsor
First posted
Sep 13, 2022
Start date
Aug 1, 2024
Primary completion
Aug 20, 2026
Completion
Jun 17, 2027 (estimated)
Last update
Sep 1, 2026

Study contacts

CHARRA BRUNAUD CLAIRE, MD
principal investigator · Institut de Cancérologie de Lorraine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion