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Trial Title:
Personalized Preventive Support for Cognitive Impairment in Non-Metastatic Breast Cancer (EFACog)
NCT ID:
NCT05538000
Condition:
No Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Face to face and telephonic interviews
Description:
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.
Arm group label:
Personalized support program
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.
Criteria for eligibility:
Criteria:
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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
65 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Institut de Cancérologie de Lorraine
Address:
City:
Vandœuvre-lès-Nancy
Zip:
54500
Country:
France
Status:
Recruiting
Contact:
Last name:
Lionel UWER, MD
Phone:
+33 3 83 59 84 61
Email:
l.uwer@nancy.unicancer.fr
Start date:
August 1, 2024
Completion date:
August 1, 2027
Lead sponsor:
Agency:
Institut de Cancérologie de Lorraine
Agency class:
Other
Source:
Institut de Cancérologie de Lorraine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05538000
