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

Hospices Civils de Lyon12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Arm A: adapted physical activity + enhanced geriatric follow-upOTHER

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 interventionOTHER

Usual clinical follow-up

Eligibility

Sex: FEMALEMin age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Claire Falandry

Lyon, France

Outcomes

Primary Outcomes

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