<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/NCT02222259</url>
  </required_header>
  <id_info>
    <org_study_id>14-7879-CE</org_study_id>
    <nct_id>NCT02222259</nct_id>
  </id_info>
  <brief_title>A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients</brief_title>
  <official_title>A Feasibility Trial of Geriatric Assessment and Management for Older Cancer Patients (A GEM Study for Older Cancer Patients)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the feasibility of implementing a randomized&#xD;
      controlled study of the intervention (Geriatric Assessment followed by an integrated care&#xD;
      plan carried out by the multidisciplinary geriatric oncology team) designed to&#xD;
      maintain/improve quality of life and functional status in older adults with advanced&#xD;
      gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy.&#xD;
&#xD;
      Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer&#xD;
      treatment decision of the cancer specialist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction: A comprehensive geriatric assessment (CGA) can identify functional and&#xD;
      psychosocial issues in older cancer patients, which in turn can inform interventions to&#xD;
      prevent/postpone adverse outcomes and maintain/improve the functional status and well-being&#xD;
      of this population. However, few randomized controlled trials (RCTs) have been completed&#xD;
      showing the evidence.&#xD;
&#xD;
      OBJECTIVE - To explore the feasibility and impact of a CGA followed by an integrated care&#xD;
      plan on quality of life and functional status for older adults with advanced breast,&#xD;
      gastrointestinal or genitourinary cancer METHODS -&#xD;
&#xD;
      A two-group parallel single-blind phase II RCT is enrolling 60 patients aged 70 or above,&#xD;
      diagnosed with cancer, and starting first line chemotherapy at Princess Margaret Cancer&#xD;
      Centre in Toronto. The randomization using sealed opaque envelopes is stratified by treatment&#xD;
      intent (adjuvant versus palliative). The intervention entails a comprehensive CGA by a&#xD;
      multidisciplinary geriatric oncology team followed by an integrated care plan to address any&#xD;
      issues identified. Participants in the intervention group are seen at baseline for the CGA&#xD;
      and for initiation of the integrated care plan, and again at 3 and 6 months to assess&#xD;
      intervention fidelity and measure outcomes. The co-primary outcomes are: 1)&#xD;
      maintaining/improvement in quality of life; 2) refining of cancer treatment plan. The&#xD;
      secondary outcomes include: 1) Functional status; 2) feasibility of the study by tumor site.&#xD;
&#xD;
      Recruitment has been completed November 2015&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Supportive Care</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>We will measure quality of life with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core version 30 items (EORTC QLQ C30)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of the Geriatric Assessment (GA) on the cancer treatment decision questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>The treating oncologist will be asked to indicate the cancer treatment plan prior to receiving the geriatric assessment results using a survey previously used in the study of Dr. Alibhai et al (Am J Clin Oncol. 2012 Aug;35(4):322-8.).&#xD;
After the GA the results will be send to the treating oncologist and after the physician will be asked to indicate whether or not and if yes how he/she modified the treatment plan based on the GA results</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional status</measure>
    <time_frame>6 months</time_frame>
    <description>We will measure functional status with the Older American Resources and Services Instrumental Activities of Daily Living questionnaire (7 items)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Gastrointestinal Cancer</condition>
  <condition>Genitourinary Cancer</condition>
  <arm_group>
    <arm_group_label>GA and Integrated Care Plan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants allocated to the intervention group will be seen in the geriatric oncology clinic where they will be assessed using a geriatric assessment. Based on the issues identified in the geriatric assessment, a care plan will be developed with the participant to address the issues.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard oncology care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to standard oncology care will receive usual care from their oncology team.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>GA and Integrated Care Plan</intervention_name>
    <description>The intervention will consist of a Geriatric Assessment conducted by a multidisciplinary geriatric oncology team followed by an integrated care plan developed and implemented by the team for those issues identified in the assessment. The study intervention includes contact with the intervention team at 4 points in time during the study: at baseline (to conduct the assessment and develop the integrated care plan), 2-3 weeks by telephone after the clinic visit to evaluate if the plan needs adjustments, at 3 and 6 months (to evaluate the outcomes of the integrated care plan; i.e., did the patient follow all recommendations of the integrated care plan and did the plan lead to the desired outcomes for the problems identified?</description>
    <arm_group_label>GA and Integrated Care Plan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of advanced (stage 2, 3 or 4) Gastrointestinal, Genitourinary, or&#xD;
             breast cancer&#xD;
&#xD;
          -  Referred for first-line chemotherapy&#xD;
&#xD;
          -  Ability to speak English&#xD;
&#xD;
          -  Physician estimated life expectancy &gt;6 months&#xD;
&#xD;
          -  An Eastern Oncology Group Collaborative (ECOG) Performance Score of 0-2&#xD;
&#xD;
          -  Ability to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous chemotherapy for current stage of disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>70 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shabbir Alibhai, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Martine Puts, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5T 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>April 10, 2018</last_update_submitted>
  <last_update_submitted_qc>April 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Toronto</investigator_affiliation>
    <investigator_full_name>Martine Puts</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Geriatric Oncology</keyword>
  <keyword>Quality of Life</keyword>
  <keyword>Comprehensive Geriatric Assessment</keyword>
  <keyword>Functional Status</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Older Adults</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastrointestinal Neoplasms</mesh_term>
    <mesh_term>Urogenital 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/NCT02222259
org study id: 14-7879-CE
nct id: NCT02222259
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine the feasibility of implementing a randomized
      controlled study of the intervention (Geriatric Assessment followed by an integrated care
      plan carried out by the multidisciplinary geriatric oncology team) designed to
      maintain/improve quality of life and functional status in older adults with advanced
      gastrointestinal, genitourinary or breast cancer referred for first line chemotherapy.

      Secondarily, the study will investigate the impact of the Geriatric Assessment on the cancer
      treatment decision of the cancer specialist.
Introduction: A comprehensive geriatric assessment (CGA) can identify functional and
      psychosocial issues in older cancer patients, which in turn can inform interventions to
      prevent/postpone adverse outcomes and maintain/improve the functional status and well-being
      of this population. However, few randomized controlled trials (RCTs) have been completed
      showing the evidence.

      OBJECTIVE - To explore the feasibility and impact of a CGA followed by an integrated care
      plan on quality of life and functional status for older adults with advanced breast,
      gastrointestinal or genitourinary cancer METHODS -

      A two-group parallel single-blind phase II RCT is enrolling 60 patients aged 70 or above,
      diagnosed with cancer, and starting first line chemotherapy at Princess Margaret Cancer
      Centre in Toronto. The randomization using sealed opaque envelopes is stratified by treatment
      intent (adjuvant versus palliative). The intervention entails a comprehensive CGA by a
      multidisciplinary geriatric oncology team followed by an integrated care plan to address any
      issues identified. Participants in the intervention group are seen at baseline for the CGA
      and for initiation of the integrated care plan, and again at 3 and 6 months to assess
      intervention fidelity and measure outcomes. The co-primary outcomes are: 1)
      maintaining/improvement in quality of life; 2) refining of cancer treatment plan. The
      secondary outcomes include: 1) Functional status; 2) feasibility of the study by tumor site.

      Recruitment has been completed November 2015
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Quality of life
time frame: 6 months
description: We will measure quality of life with European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core version 30 items (EORTC QLQ C30)
measure: Impact of the Geriatric Assessment (GA) on the cancer treatment decision questionnaire
time frame: 6 months
description: The treating oncologist will be asked to indicate the cancer treatment plan prior to receiving the geriatric assessment results using a survey previously used in the study of Dr. Alibhai et al (Am J Clin Oncol. 2012 Aug;35(4):322-8.).
After the GA the results will be send to the treating oncologist and after the physician will be asked to indicate whether or not and if yes how he/she modified the treatment plan based on the GA results
measure: Functional status
time frame: 6 months
description: We will measure functional status with the Older American Resources and Services Instrumental Activities of Daily Living questionnaire (7 items)
arm group label: GA and Integrated Care Plan
arm group type: Experimental
description: Participants allocated to the intervention group will be seen in the geriatric oncology clinic where they will be assessed using a geriatric assessment. Based on the issues identified in the geriatric assessment, a care plan will be developed with the participant to address the issues.
arm group label: Standard oncology care
arm group type: No Intervention
description: Participants randomized to standard oncology care will receive usual care from their oncology team.
intervention type: Procedure
intervention name: GA and Integrated Care Plan
description: The intervention will consist of a Geriatric Assessment conducted by a multidisciplinary geriatric oncology team followed by an integrated care plan developed and implemented by the team for those issues identified in the assessment. The study intervention includes contact with the intervention team at 4 points in time during the study: at baseline (to conduct the assessment and develop the integrated care plan), 2-3 weeks by telephone after the clinic visit to evaluate if the plan needs adjustments, at 3 and 6 months (to evaluate the outcomes of the integrated care plan; i.e., did the patient follow all recommendations of the integrated care plan and did the plan lead to the desired outcomes for the problems identified?
arm group label: GA and Integrated Care Plan
criteria: 
gender: All
minimum age: 70 Years
maximum age: N/A
healthy volunteers: No
last name: Shabbir Alibhai, MD
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Martine Puts, PhD
role: Principal Investigator
affiliation: University of Toronto
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Toronto
investigator full name: Martine Puts
investigator title: Assistant Professor
mesh term: Gastrointestinal Neoplasms
mesh term: Urogenital Neoplasms