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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Personalized support program | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess program feasibility | Rate of patients who participated in all provider interviews (face-to-face and telephone contacts). | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| The cognitive complaint | The cognitive complaint will be assessed by the FACT-Cog questionnaire comprising 37 items. | 9 months |
| The Quality of life of patients | Quality of life will be assessed by the generic QLQ-C30 questionnaire of 30 items. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| LIONEL UWER, MD | Institut de Cancérologie de Lorraine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut de Cancérologie de Lorraine | Vandœuvre-lès-Nancy | Vandoeuvres Les Nancy | 54500 | France |
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| 9 months |
| Fatigue | Fatigue will be assessed by the QLQ-FA12 questionnaire of 12 items. | 9 months |
| Anxiety and depression | Anxiety/depression will be assessed by the 14-item HADS questionnaire (7 items: anxiety / 7 items: depression). | 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. | 9 months |
| Satisfaction of patients | Satisfaction will be assessed by a numerical scale (0: not satisfied to 10: very satisfied). | 9 months |