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.

Hospices Civils de Lyon1 site in 1 country12 target enrollmentApril 11, 2014

ConditionsBreast Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Hospices Civils de Lyon
Enrollment: 12
Locations: 1
Primary Endpoint: Compliance of an adjuvant hormonal therapy
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

April 11, 2014

End Date

February 4, 2019

Last Updated

7 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Hospices Civils de Lyon

Responsible Party

Sponsor

Eligibility Criteria

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

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)