Breast Cancer
Conditions
Keywords
oncogeriatrics, adjuvant endocrine therapy, compliance, elderly, Taï Chi, Physical training
Brief summary
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.
Interventions
OTHERArm 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).
OTHERNo intervention
Usual clinical follow-up
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compliance of an adjuvant hormonal therapy | 3 years of follow up | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intensity and duration of musculoskeletal adverse events | 3 years of follow up | Musculoskeletal adverse events will be graded using NCI CTC version 4.0 |
| Activities of daily living, functional walking capacity and changes in balance | 3 years of follow up | — |
| Quality of life | 3 years of follow up | Using the Functional Assessment of Cancer Therapy General (FACT-G7) questionnaire |
| Nutritional status | 3 years of follow up | Using Mini Nutritional Assessment, weight, weight loss, albuminemia |
| Analgesics consumption | 3 years of follow up | issued from the exhaustive list of documented concomitant medications |
Countries
France
Outcome results
None listed