PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program

Study Overview
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Brief Summary
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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: A regular geriatric follow up including an attentive screening of joint symptoms and functionality, An adapted treatment of join pain, Weekly sessions of adapted physical activity (Taï Chi), And a systematic correction of vitamin D deficits.

Official Title
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PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program Including a Regular Physical Training, a Medical and Nutritional Follow-up, on Adjuvant Hormonal Treatment Compliance in Breast Cancer Patients Over 70 Years.

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Arm A: adapted physical activity + enhanced geriatric follow-up
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 70 years old Non metastatic breast cancer, with or without node metastases Hormone Receptor (HR) positive breast cancer patients Women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery or radiotherapy Introduce an hormonal therapy during 5 years Life expectancy > 6 months (at the discretion of the investigator) Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research Patient must be available for follow-up Having given written informed consent prior to any procedure related to the study Exclusion Criteria: No other primary malignant tumor < 5-years old except cured in situ cancer of the cervix, in situ urothelial cancer, or basocellular cancer Patient with an experimental treatment in the 30 days prior to the enrollment Evidence of metastatic disease Not under any administrative or legal supervision

Ages Eligible for Study
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Minimum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A: Interventional adapted physical activity + enhanced geriatr<br>Geriatric (functionality, gait, nutrition) follow-up, biological tests, anti-aromatase agents blood dosing, clinical assessment. Weekly Taï-Chi exercises. | Other: Arm A: adapted physical activity + enhanced geriatric follow-up<br>* 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).<br>|
| Other: Arm B: control<br>Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment | Other: No intervention<br>* Usual clinical follow-up<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oncogeriatrics, adjuvant endocrine therapy, compliance, elderly, Taï Chi, Physical training