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

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.

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 Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Arm A: adapted physical activity + enhanced geriatric follow-up; Other: No intervention

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France
    • Claire Falandry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 70 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: 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).
Other: Arm B: control; Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment	Other: No intervention; Usual clinical follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	3 years of follow up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intensity and duration of musculoskeletal adverse events	Musculoskeletal adverse events will be graded using NCI CTC version 4.0	3 years of follow up
Activities of daily living, functional walking capacity and changes in balance		3 years of follow up
Quality of life	Using the Functional Assessment of Cancer Therapy General (FACT-G7) questionnaire	3 years of follow up
Nutritional status	Using Mini Nutritional Assessment, weight, weight loss, albuminemia	3 years of follow up
Analgesics consumption	issued from the exhaustive list of documented concomitant medications	3 years of follow up

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Claire Falandry, MD-PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): April 11, 2014
• Primary Completion (Actual): February 1, 2019
• Study Completion (Actual): February 4, 2019

Study Registration Dates

• First Submitted: August 6, 2014
• First Submitted That Met QC Criteria: August 12, 2014
• First Posted (Estimated): August 13, 2014

Study Record Updates

• Last Update Posted (Estimated): October 2, 2025
• Last Update Submitted That Met QC Criteria: September 27, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: compliance; elderly; adjuvant endocrine therapy; Physical training; oncogeriatrics; Taï Chi
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Behavior; Skin and Connective Tissue Diseases; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Breast Neoplasms; Patient Compliance
• Other Study ID Numbers: 2012-777