No Metastatic Breast CancerEFACogNCT05538000
Personalized Preventive Support for Cognitive Impairment in Non-Metastatic Breast Cancer (EFACog)
A study testing Face to face and telephonic interviews in people with No Metastatic Breast Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- No Metastatic Breast Cancer
- What is being tested?
- Face to face and telephonic interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2024to 20 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, Vandoeuvres Les Nancy, 54500
About this study
Official 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).
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.
- Conditions
- No Metastatic Breast Cancer
- Being tested
- Face to face and telephonic interviews
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face to face and telephonic interviewsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Personalized support program | Experimental | Not described Receives: Other: Face to face and telephonic interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess program feasibility
Rate of patients who participated in all provider interviews (face-to-face and telephone contacts).
Measured: 9 months
Secondary outcomes (6)
The cognitive complaint
The cognitive complaint will be assessed by the FACT-Cog questionnaire comprising 37 items.
Measured: 9 months
The Quality of life of patients
Quality of life will be assessed by the generic QLQ-C30 questionnaire of 30 items.
Measured: 9 months
Fatigue
Fatigue will be assessed by the QLQ-FA12 questionnaire of 12 items.
Measured: 9 months
Anxiety and depression
Anxiety/depression will be assessed by the 14-item HADS questionnaire (7 items: anxiety / 7 items: depression).
Measured: 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.
Measured: 9 months
Satisfaction of patients
Satisfaction will be assessed by a numerical scale (0: not satisfied to 10: very satisfied).
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2022
- Study start1 Aug 2024
- Primary completion20 Aug 2026
- Study completion20 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for No Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Cancérologie de Lorraine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- CHARRA BRUNAUD CLAIRE, MD, Principal investigator, Institut de Cancérologie de Lorraine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05538000
- Sponsor's protocol ID
- ICL-2022-1
- Acronym
- EFACog
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2022
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT05538000
- Acronym / sponsor ID
- EFACog / ICL-2022-1
- Conditions
- No Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Institut de Cancérologie de LorraineUniversity, hospital or other
- Study start
- 1 Aug 2024 (actual)
- Primary completion
- 20 Aug 2026 (actual)
- Study completion
- 20 Aug 2027 (estimated)
- First posted
- 13 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Personalized support program | Experimental | Other: Face to face and telephonic interviews |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face to face and telephonic interviewsface 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. | Other | Personalized support program |
Primary outcome
To assess program feasibility
Time frame: 9 months
Rate of patients who participated in all provider interviews (face-to-face and telephone contacts).
6 secondary outcomes
The cognitive complaint
Time frame: 9 months
The Quality of life of patients
Time frame: 9 months
Fatigue
Time frame: 9 months
Anxiety and depression
Time frame: 9 months
Appearance of neurocognitive disorders and/or significant cognitive complaints
Time frame: 9 months
Satisfaction of patients
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
CHARRA BRUNAUD CLAIRE, MD principal investigator
Institut de Cancérologie de Lorraine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face to face and telephonic interviews in people with No Metastatic Breast Cancer, run by Institut de Cancérologie de Lorraine at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess program feasibility (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.