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PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric intervention on treatment compliance, measured regularly by blood dosing of drug metabolites.
Patients in the intervention group will be proposed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Interventional adapted physical activity + enhanced geriatr | Experimental | Geriatric (functionality, gait, nutrition) follow-up, biological tests, anti-aromatase agents blood dosing, clinical assessment. Weekly Taï-Chi exercises. |
|
| Arm B: control | Other | Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arm A: adapted physical activity + enhanced geriatric follow-up | Other | Patients have 3-monthly geriatric follow-up with biological tests, anti-aromatase agents blood dosing and a clinical assessment (M3 to M9, M15 to M22 and M27 to M33). Musculoskeletal adverse events and quality of life level will be reported and analgesic treatment adapted. Patients will be proposed weekly Taï-Chi exercises to improve joint flexibility, muscular tonus and balance and reduce fall risk. A broader geriatric assessment including functionality, gait analysis and nutrition will be performed each year (M12, M24 and M36). |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance of an adjuvant hormonal therapy | Compliance rate is defined as the rate of blood samplings of anti-hormone metabolites in the therapeutic range, within the 7 blood samplings distributed in the 3 years of follow-up | 3 years of follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Intensity and duration of musculoskeletal adverse events | Musculoskeletal adverse events will be graded using NCI CTC version 4.0 | 3 years of follow up |
| Activities of daily living, functional walking capacity and changes in balance |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claire Falandry, MD-PhD | Hospices Civils de Lyon | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Claire Falandry | Lyon | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| No intervention | Other | Usual clinical follow-up |
|
| 3 years of follow up |
| Quality of life | Using the Functional Assessment of Cancer Therapy General (FACT-G7) questionnaire | 3 years of follow up |
| Nutritional status | Using Mini Nutritional Assessment, weight, weight loss, albuminemia | 3 years of follow up |
| Analgesics consumption | issued from the exhaustive list of documented concomitant medications | 3 years of follow up |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |