<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/NCT03775616</url>
  </required_header>
  <id_info>
    <org_study_id>RG1001593</org_study_id>
    <secondary_id>NCI-2018-02607</secondary_id>
    <secondary_id>8570</secondary_id>
    <nct_id>NCT03775616</nct_id>
  </id_info>
  <brief_title>Financial Navigation Program Intervention in Supporting Patients With Solid Tumors and Their Caregivers</brief_title>
  <official_title>Development of a Comprehensive Financial Navigation Program for Patients With Cancer and Their Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fred Hutchinson Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Fred Hutchinson Cancer Center</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial studies how well a financial navigation program intervention works in supporting&#xD;
      patients with solid tumors and their caregivers. The financial navigation program&#xD;
      intervention is an educational course about cancer treatment cost. This educational course&#xD;
      may provide cancer patients and their caregivers with helpful information about dealing with&#xD;
      cancer treatment cost.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants receive financial navigation program intervention consisting of a financial&#xD;
      navigation video, monthly one-one financial counselling session, monthly phone or email&#xD;
      consultation with patient navigators for 6 months and complete surveys at baseline, 3, 6, and&#xD;
      12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 15, 2017</start_date>
  <completion_date type="Actual">May 15, 2019</completion_date>
  <primary_completion_date type="Actual">May 15, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accrual rate (number of patients and caregivers enrolled per month)</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to accrual</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants completing each of the 3 program components</measure>
    <time_frame>Up to 12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of participants completing the entire program and 6 month follow up</measure>
    <time_frame>Up to 6 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Financial status assessment</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Prior to and following participation in the financial navigation program, patients will complete questionnaire and provide basic information about their financial status including household income, assets, educational level, and employment status.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Financial distress assessment questionnaire</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Will measure patients' level of financial distress before and after participation in various components of the program via a questionnaire that indicates financial distress based on responses</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Patient advocate foundation (PAF) navigators</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>PAF navigators will tract all issues identified during an initial need assessment with the patients and subsequently all outcomes of any such issues.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Consumer education and training services (CENTS) financial counselors</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The CENTs financial counselors will tract specific recommendations given each patient during the course of the study and share these recommendation with the investigators.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Family Reach staff feedback</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Family Reach will track patients that have been granted financial assistance, and will provide any further information obtained from patients interaction.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Caregiver</condition>
  <condition>Solid Neoplasm</condition>
  <arm_group>
    <arm_group_label>Supportive (financial navigation program)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive financial navigation program intervention consisting of a financial navigation video, monthly one-one financial counselling session, monthly phone or email consultation with patient navigators for 6 months and complete surveys at baseline, 3, 6, and 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational Intervention</intervention_name>
    <description>Receive financial navigation program intervention</description>
    <arm_group_label>Supportive (financial navigation program)</arm_group_label>
    <other_name>Education for Intervention</other_name>
    <other_name>Intervention by Education</other_name>
    <other_name>Intervention through Education</other_name>
    <other_name>Intervention, Educational</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire Administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive (financial navigation program)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Quality-of-Life Assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Supportive (financial navigation program)</arm_group_label>
    <other_name>Quality of Life Assessment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PATIENTS: Any solid tumor diagnosis (any stage)&#xD;
&#xD;
          -  PATIENTS: Currently receiving (or completed within 6 months) chemotherapy, radiation,&#xD;
             or hormonal therapy for cancer&#xD;
&#xD;
          -  PATIENTS: In the treating physician's best estimation, has a life expectancy of 6&#xD;
             months or greater&#xD;
&#xD;
          -  PATIENTS: Able to identify a primary caregiver who is involved in helping with the&#xD;
             logistics, financial, or emotional aspects of his/her cancer care&#xD;
&#xD;
          -  PATIENTS: English-speaking&#xD;
&#xD;
          -  CAREGIVERS: Caregiver of a patient who is eligible for to participate in the study&#xD;
&#xD;
          -  CAREGIVERS: English-speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PATIENTS: Cognitive or other impairment that would interfere with ability to&#xD;
             understand and/or respond to questions about personal finances and paying for cancer&#xD;
             treatment&#xD;
&#xD;
          -  PATIENTS: Hematologic malignancy (e.g. multiple myeloma, lymphoma, leukemia)&#xD;
&#xD;
          -  CAREGIVERS: cognitive or other impairment that would interfere with ability to&#xD;
             understand and/or respond to questions about patient fiances and paying for cancer&#xD;
             treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Veena Shankaran</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fred Hutch/University of Washington Cancer Consortium</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fred Hutch/University of Washington Cancer Consortium</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>May 16, 2019</last_update_submitted>
  <last_update_submitted_qc>May 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 20, 2019</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/NCT03775616
org study id: RG1001593
secondary id: NCI-2018-02607
secondary id: 8570
nct id: NCT03775616
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This trial studies how well a financial navigation program intervention works in supporting
      patients with solid tumors and their caregivers. The financial navigation program
      intervention is an educational course about cancer treatment cost. This educational course
      may provide cancer patients and their caregivers with helpful information about dealing with
      cancer treatment cost.
Participants receive financial navigation program intervention consisting of a financial
      navigation video, monthly one-one financial counselling session, monthly phone or email
      consultation with patient navigators for 6 months and complete surveys at baseline, 3, 6, and
      12 months.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Accrual rate (number of patients and caregivers enrolled per month)
time frame: Up to 12 months
measure: Time to accrual
time frame: Up to 12 months
measure: Proportion of participants completing each of the 3 program components
time frame: Up to 12 months
measure: Proportion of participants completing the entire program and 6 month follow up
time frame: Up to 6 months
measure: Financial status assessment
time frame: Up to 12 months
description: Prior to and following participation in the financial navigation program, patients will complete questionnaire and provide basic information about their financial status including household income, assets, educational level, and employment status.
measure: Financial distress assessment questionnaire
time frame: Up to 12 months
description: Will measure patients' level of financial distress before and after participation in various components of the program via a questionnaire that indicates financial distress based on responses
measure: Patient advocate foundation (PAF) navigators
time frame: Up to 12 months
description: PAF navigators will tract all issues identified during an initial need assessment with the patients and subsequently all outcomes of any such issues.
measure: Consumer education and training services (CENTS) financial counselors
time frame: Up to 12 months
description: The CENTs financial counselors will tract specific recommendations given each patient during the course of the study and share these recommendation with the investigators.
measure: Family Reach staff feedback
time frame: Up to 12 months
description: Family Reach will track patients that have been granted financial assistance, and will provide any further information obtained from patients interaction.
arm group label: Supportive (financial navigation program)
arm group type: Experimental
description: Participants receive financial navigation program intervention consisting of a financial navigation video, monthly one-one financial counselling session, monthly phone or email consultation with patient navigators for 6 months and complete surveys at baseline, 3, 6, and 12 months.
intervention type: Other
intervention name: Educational Intervention
description: Receive financial navigation program intervention
arm group label: Supportive (financial navigation program)
other name: Education for Intervention
other name: Intervention by Education
other name: Intervention through Education
other name: Intervention, Educational
intervention type: Other
intervention name: Questionnaire Administration
description: Ancillary studies
arm group label: Supportive (financial navigation program)
intervention type: Other
intervention name: Quality-of-Life Assessment
description: Ancillary studies
arm group label: Supportive (financial navigation program)
other name: Quality of Life Assessment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Veena Shankaran
role: Principal Investigator
affiliation: Fred Hutch/University of Washington Cancer Consortium
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No