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

NCT02216162 | Completed

• 1 other identifier: 2012-777
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

oncogeriatrics; adjuvant endocrine therapy; compliance; elderly; Taï Chi; Physical training

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Intensity and duration of musculoskeletal adverse events

  3 years of follow up

• Activities of daily living, functional walking capacity and changes in balance

  3 years of follow up

• Quality of life

  3 years of follow up

• Nutritional status

  3 years of follow up

• Analgesics consumption

  3 years of follow up

Study Arms (2)

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.

Other: Arm A: adapted physical activity + enhanced geriatric follow-up

Arm B: control

OTHER

Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment

Other: No intervention

Interventions

Arm A: adapted physical activity + enhanced geriatric follow-up OTHER

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).

A: Interventional adapted physical activity + enhanced geriatr

No intervention OTHER

Usual clinical follow-up

Arm B: control

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Claire Falandry

Lyon, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Patient Compliance

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Claire Falandry, MD-PhD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2014
• First Posted: August 13, 2014
• Study Start: April 11, 2014
• Primary Completion: February 1, 2019
• Study Completion: February 4, 2019
• Last Updated: October 2, 2025

Record last verified: 2025-09

Locations

FR (1)