PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program
NCT ID: NCT02216162
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
12 participants
INTERVENTIONAL
2014-04-11
2019-02-04
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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A: Interventional adapted physical activity + enhanced geriatr
Geriatric (functionality, gait, nutrition) follow-up, biological tests, anti-aromatase agents blood dosing, clinical assessment. Weekly Taï-Chi exercises.
Arm A: adapted physical activity + enhanced geriatric follow-up
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).
Arm B: control
Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment
No intervention
Usual clinical follow-up
Interventions
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Arm A: adapted physical activity + enhanced geriatric follow-up
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).
No intervention
Usual clinical follow-up
Eligibility Criteria
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Inclusion Criteria
* 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
* Patient with an experimental treatment in the 30 days prior to the enrollment
* Evidence of metastatic disease
* Not under any administrative or legal supervision
70 Years
FEMALE
No
Sponsors
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Hospices Civils de Lyon
OTHER
Responsible Party
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Principal Investigators
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Claire Falandry, MD-PhD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
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Claire Falandry
Lyon, , France
Countries
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Other Identifiers
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2012-777
Identifier Type: -
Identifier Source: org_study_id
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