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Completed

NCT Number: NCT02216162

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

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.

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Key information

Conditions

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

Age range

70 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Claire Falandry

Lyon, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

No intervention

Other

Usual clinical follow-up

Primary outcomes

  1. 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

  1. Intensity and duration of musculoskeletal adverse events

    Time frame: 3 years of follow up

    Musculoskeletal adverse events will be graded using NCI CTC version 4.0

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

    Time frame: 3 years of follow up

  3. Quality of life

    Time frame: 3 years of follow up

    Using the Functional Assessment of Cancer Therapy General (FACT-G7) questionnaire

  4. Nutritional status

    Time frame: 3 years of follow up

    Using Mini Nutritional Assessment, weight, weight loss, albuminemia

  5. Analgesics consumption

    Time frame: 3 years of follow up

    issued from the exhaustive list of documented concomitant medications

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study 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.

Acronym: PROACTIVE

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Aug 13, 2014
Registry last updated
Oct 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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