<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02216162</url>
  </required_header>
  <id_info>
    <org_study_id>2012-777</org_study_id>
    <nct_id>NCT02216162</nct_id>
  </id_info>
  <brief_title>PROACTIVE Study Evaluation of the Impact of a Multidimensional Geriatric Intervention Program</brief_title>
  <acronym>PROACTIVE</acronym>
  <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.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      PROACTIVE randomized study to evaluate the impact of a multidimensional geriatric&#xD;
      intervention on treatment compliance, measured regularly by blood dosing of drug metabolites.&#xD;
&#xD;
      Patients in the intervention group will be proposed:&#xD;
&#xD;
        -  A regular geriatric follow up including an attentive screening of joint symptoms and&#xD;
           functionality,&#xD;
&#xD;
        -  An adapted treatment of join pain,&#xD;
&#xD;
        -  Weekly sessions of adapted physical activity (Taï Chi),&#xD;
&#xD;
        -  And a systematic correction of vitamin D deficits.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 11, 2014</start_date>
  <completion_date type="Actual">February 4, 2019</completion_date>
  <primary_completion_date type="Actual">February 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Compliance of an adjuvant hormonal therapy</measure>
    <time_frame>3 years of follow up</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intensity and duration of musculoskeletal adverse events</measure>
    <time_frame>3 years of follow up</time_frame>
    <description>Musculoskeletal adverse events will be graded using NCI CTC version 4.0</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities of daily living, functional walking capacity and changes in balance</measure>
    <time_frame>3 years of follow up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>3 years of follow up</time_frame>
    <description>Using the Functional Assessment of Cancer Therapy General (FACT-G7) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutritional status</measure>
    <time_frame>3 years of follow up</time_frame>
    <description>Using Mini Nutritional Assessment, weight, weight loss, albuminemia</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Analgesics consumption</measure>
    <time_frame>3 years of follow up</time_frame>
    <description>issued from the exhaustive list of documented concomitant medications</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>A: Interventional adapted physical activity + enhanced geriatr</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Geriatric (functionality, gait, nutrition) follow-up, biological tests, anti-aromatase agents blood dosing, clinical assessment. Weekly Taï-Chi exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B: control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Arm A: adapted physical activity + enhanced geriatric follow-up</intervention_name>
    <description>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.&#xD;
A broader geriatric assessment including functionality, gait analysis and nutrition will be performed each year (M12, M24 and M36).</description>
    <arm_group_label>A: Interventional adapted physical activity + enhanced geriatr</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Usual clinical follow-up</description>
    <arm_group_label>Arm B: control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 70 years old&#xD;
&#xD;
          -  Non metastatic breast cancer, with or without node metastases&#xD;
&#xD;
          -  Hormone Receptor (HR) positive breast cancer patients&#xD;
&#xD;
          -  Women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery&#xD;
             or radiotherapy&#xD;
&#xD;
          -  Introduce an hormonal therapy during 5 years&#xD;
&#xD;
          -  Life expectancy &gt; 6 months (at the discretion of the investigator)&#xD;
&#xD;
          -  Covered by a Health System where applicable, and/or in compliance with the&#xD;
             recommendations of the national laws in force relating to biomedical research&#xD;
&#xD;
          -  Patient must be available for follow-up&#xD;
&#xD;
          -  Having given written informed consent prior to any procedure related to the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No other primary malignant tumor &lt; 5-years old except cured in situ cancer of the&#xD;
             cervix, in situ urothelial cancer, or basocellular cancer&#xD;
&#xD;
          -  Patient with an experimental treatment in the 30 days prior to the enrollment&#xD;
&#xD;
          -  Evidence of metastatic disease&#xD;
&#xD;
          -  Not under any administrative or legal supervision&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claire Falandry, MD-PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Claire Falandry</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>March 19, 2019</last_update_submitted>
  <last_update_submitted_qc>March 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>oncogeriatrics</keyword>
  <keyword>adjuvant endocrine therapy</keyword>
  <keyword>compliance</keyword>
  <keyword>elderly</keyword>
  <keyword>Taï Chi</keyword>
  <keyword>Physical training</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02216162
org study id: 2012-777
nct id: NCT02216162
lead sponsor: 
has dmc: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Compliance of an adjuvant hormonal therapy
time frame: 3 years of follow up
description: 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
measure: Intensity and duration of musculoskeletal adverse events
time frame: 3 years of follow up
description: Musculoskeletal adverse events will be graded using NCI CTC version 4.0
measure: Activities of daily living, functional walking capacity and changes in balance
time frame: 3 years of follow up
measure: Quality of life
time frame: 3 years of follow up
description: Using the Functional Assessment of Cancer Therapy General (FACT-G7) questionnaire
measure: Nutritional status
time frame: 3 years of follow up
description: Using Mini Nutritional Assessment, weight, weight loss, albuminemia
measure: Analgesics consumption
time frame: 3 years of follow up
description: issued from the exhaustive list of documented concomitant medications
arm group label: A: Interventional adapted physical activity + enhanced geriatr
arm group type: Experimental
description: Geriatric (functionality, gait, nutrition) follow-up, biological tests, anti-aromatase agents blood dosing, clinical assessment. Weekly Taï-Chi exercises.
arm group label: Arm B: control
arm group type: Other
description: Clinical follow-up according to the Guidelines, annual geriatric and nutritional assessment
intervention type: Other
intervention name: Arm A: adapted physical activity + enhanced geriatric follow-up
description: 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).
arm group label: A: Interventional adapted physical activity + enhanced geriatr
intervention type: Other
intervention name: No intervention
description: Usual clinical follow-up
arm group label: Arm B: control
criteria: 
gender: Female
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Claire Falandry, MD-PhD
role: Principal Investigator
affiliation: Hospices Civils de Lyon
facility: 
country: France
responsible party type: Sponsor
mesh term: Breast Neoplasms