No Metastatic Breast Cancer
Conditions
Brief 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.
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.
Sponsors
Institut de Cancérologie de Lorraine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess program feasibility | 9 months | Rate of patients who participated in all provider interviews (face-to-face and telephone contacts). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The cognitive complaint | 9 months | The cognitive complaint will be assessed by the FACT-Cog questionnaire comprising 37 items. |
| The Quality of life of patients | 9 months | Quality of life will be assessed by the generic QLQ-C30 questionnaire of 30 items. |
| Fatigue | 9 months | Fatigue will be assessed by the QLQ-FA12 questionnaire of 12 items. |
| Anxiety and depression | 9 months | Anxiety/depression will be assessed by the 14-item HADS questionnaire (7 items: anxiety / 7 items: depression). |
| Appearance of neurocognitive disorders and/or significant cognitive complaints | 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. |
| Satisfaction of patients | 9 months | Satisfaction will be assessed by a numerical scale (0: not satisfied to 10: very satisfied). |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORCHARRA BRUNAUD CLAIRE, MD
Institut de Cancérologie de Lorraine
Outcome results
None listed