<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/NCT02204137</url>
  </required_header>
  <id_info>
    <org_study_id>201407080</org_study_id>
    <nct_id>NCT02204137</nct_id>
  </id_info>
  <brief_title>Falls Risk Questionnaire in Older Adults With Cancer</brief_title>
  <official_title>Pilot Study of the Falls Risk Questionnaire in Older Adults With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Washington University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research study is to look at the use of a series of questionnaires&#xD;
      evaluating risk for falls in order to collect information that might be used to develop a&#xD;
      larger study aiming to recognize who is more at risk for falls and how to best intervene to&#xD;
      prevent falls in older adults with cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">November 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percent completion of the Fall Risk Questionnaire (FRQ) and the Cancer and Aging Research Group Geriatric Assessment (CARG GA) of enrolled patients</measure>
    <time_frame>Day 1</time_frame>
    <description>The percent of patients who complete the assessment will be calculated. Successful completion will be defined as the completion of all items on the questionnaires. If more than 85% of subjects are able to complete the FRQ and CARG GA, the assessment will be deemed feasible.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to completion of FRQ and CARG GA of enrolled patients</measure>
    <time_frame>Day 1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with the questionnaires</measure>
    <time_frame>Day 1</time_frame>
    <description>We will calculate the frequency of participant feedback that 1) certain questions that were difficult to understand 2) the questionnaire was too short or too long 3) questions were upsetting or 4) the questionnaire left out important questions to ask. Open-ended follow-up questions in which the participants will be given the opportunity to write out their responses will be examined qualitatively for recurring themes of particular questions that were unsatisfactory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychological consequences of falling</measure>
    <time_frame>Day 1</time_frame>
    <description>Uses the Falls Efficacy Scale-International (FES-I) and Health Related Quality of Life (HRQOL) using the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity Scale (FACT GOG/NTX)</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">21</enrollment>
  <condition>Cancer</condition>
  <condition>Geriatric Assessment</condition>
  <arm_group>
    <arm_group_label>Completion of Questionnaires</arm_group_label>
    <description>Participants will complete an assessment consisting of the Falls Risk Questionnaire, a primarily self-administered geriatric assessment (GA) developed by the Cancer and Aging Research Group, a quality of life scale (FACT GOG/NTX) and the Falls Efficacy Scale-International.&#xD;
Each questionnaire contains approximately 150 questions and will take between 30 minutes and one hour to complete.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Falls Risk Questionnaire</intervention_name>
    <arm_group_label>Completion of Questionnaires</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cancer and Aging Research Group Geriatric Assessment</intervention_name>
    <arm_group_label>Completion of Questionnaires</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Falls Efficacy Scale-International (FES-1)</intervention_name>
    <arm_group_label>Completion of Questionnaires</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Health Related Quality of Life using the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity Scale (FACT GOG/NTX)</intervention_name>
    <arm_group_label>Completion of Questionnaires</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Cancer patients aged 65 years of age or older&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 65 or older; 5 patients will be enrolled in each of the following age cohorts:&#xD;
             65-69, 70-74, 75-79, 80 and older&#xD;
&#xD;
          -  Diagnosis of cancer, any type&#xD;
&#xD;
          -  Currently receiving or anticipated to initiate systemic cancer therapy within 1 month,&#xD;
             including endocrine therapy, chemotherapy or targeted therapies&#xD;
&#xD;
          -  Able to understand and willing to sign an IRB-approved written informed consent&#xD;
             document&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to understand written English&#xD;
&#xD;
          -  Psychiatric illness/social situation that would limit compliance with the study&#xD;
             requirements&#xD;
&#xD;
          -  Unable to walk.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tanya Wildes, M.D., M.S.C.I.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Washington University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.siteman.wustl.edu</url>
    <description>Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine</description>
  </link>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>April 27, 2017</last_update_submitted>
  <last_update_submitted_qc>April 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02204137
org study id: 201407080
nct id: NCT02204137
lead sponsor: 
has dmc: No
The purpose of this research study is to look at the use of a series of questionnaires
      evaluating risk for falls in order to collect information that might be used to develop a
      larger study aiming to recognize who is more at risk for falls and how to best intervene to
      prevent falls in older adults with cancer.
observational model: Cohort
time perspective: Prospective
measure: Percent completion of the Fall Risk Questionnaire (FRQ) and the Cancer and Aging Research Group Geriatric Assessment (CARG GA) of enrolled patients
time frame: Day 1
description: The percent of patients who complete the assessment will be calculated. Successful completion will be defined as the completion of all items on the questionnaires. If more than 85% of subjects are able to complete the FRQ and CARG GA, the assessment will be deemed feasible.
measure: Time to completion of FRQ and CARG GA of enrolled patients
time frame: Day 1
measure: Satisfaction with the questionnaires
time frame: Day 1
description: We will calculate the frequency of participant feedback that 1) certain questions that were difficult to understand 2) the questionnaire was too short or too long 3) questions were upsetting or 4) the questionnaire left out important questions to ask. Open-ended follow-up questions in which the participants will be given the opportunity to write out their responses will be examined qualitatively for recurring themes of particular questions that were unsatisfactory
measure: Psychological consequences of falling
time frame: Day 1
description: Uses the Falls Efficacy Scale-International (FES-I) and Health Related Quality of Life (HRQOL) using the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity Scale (FACT GOG/NTX)
arm group label: Completion of Questionnaires
description: Participants will complete an assessment consisting of the Falls Risk Questionnaire, a primarily self-administered geriatric assessment (GA) developed by the Cancer and Aging Research Group, a quality of life scale (FACT GOG/NTX) and the Falls Efficacy Scale-International.
Each questionnaire contains approximately 150 questions and will take between 30 minutes and one hour to complete.
intervention type: Other
intervention name: Falls Risk Questionnaire
arm group label: Completion of Questionnaires
intervention type: Other
intervention name: Cancer and Aging Research Group Geriatric Assessment
arm group label: Completion of Questionnaires
intervention type: Other
intervention name: Falls Efficacy Scale-International (FES-1)
arm group label: Completion of Questionnaires
intervention type: Other
intervention name: Health Related Quality of Life using the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity Scale (FACT GOG/NTX)
arm group label: Completion of Questionnaires
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
healthy volunteers: No
last name: Tanya Wildes, M.D., M.S.C.I.
role: Principal Investigator
affiliation: Washington University School of Medicine
facility: 
country: United States
url: http://www.siteman.wustl.edu
description: Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
responsible party type: Sponsor
sharing ipd: No