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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Other: No intervention

• Registration Number: NCT02216162
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-11
• Study First Submitted: 2014-08-06
• Study First Submitted QC: 2014-08-12
• Study First Posted: 2014-08-13
• Primary Completion: 2019-02
• Study Completion: 2019-02-04
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm B: control	No intervention	Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Intensity and duration of musculoskeletal adverse events	3 years of follow up	Musculoskeletal adverse events will be graded using NCI CTC version 4.0
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

Trial Locations

Locations (1)

Claire Falandry; 🇫🇷 Lyon, France