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

Breast Cancer Clinical Trial

— PROACTIVE  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02216162
• Other study ID #: 2012-777
• Status: Completed
• Phase: N/A
• Start date: April 11, 2014
• Est. completion date: February 4, 2019

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: February 4, 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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).
• No intervention
Usual clinical follow-up

Locations

Country	Name	City	State
France	Claire Falandry	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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