NCT02216162CompletedNot Applicable
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
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Hospices Civils de Lyon
- Enrollment
- 12
- Locations
- 2
- Primary Endpoint
- Compliance of an adjuvant hormonal therapy
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 70 Years to — (Older Adult)
- Sex
- Female
- Accepts 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
Arms & Interventions
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.
Intervention: Arm A: adapted physical activity + enhanced geriatric follow-up (Other)
Arm B: control
Other
Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment
Intervention: No intervention (Other)
Outcomes
Primary Outcomes
Compliance of an adjuvant hormonal therapy
Time Frame: 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 Outcomes
- Activities of daily living, functional walking capacity and changes in balance(3 years of follow up)
- Quality of life(3 years of follow up)
- Intensity and duration of musculoskeletal adverse events(3 years of follow up)
- Nutritional status(3 years of follow up)
- Analgesics consumption(3 years of follow up)
Investigators
Study Sites (2)
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