xml: <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/NCT05978232</url>
    </required_header>
    <id_info>
      <org_study_id>CASE1123</org_study_id>
      <nct_id>NCT05978232</nct_id>
    </id_info>
    <brief_title>NAVAH Impact on Radiation Therapy Completion in Black Breast &amp; Prostate Cancer Patients</brief_title>
    <official_title>Prospective Pilot Study of Navigator-Assisted Hypofractionation (NAVAH) Impact on Radiation Therapy Completion in Black Breast &amp; Prostate Cancer Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Case Comprehensive Cancer Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Susan G. Komen Breast Cancer Foundation</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Gilead Sciences</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>University Hospitals Cleveland Medical Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Case Comprehensive Cancer Center</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        African-Americans have disparately limited access to optimal cancer care. They have the&#xD;
        highest overall cancer death rate and shortest survival time of any racial or ethnic group in&#xD;
        the United States. Elucidation of disparities in access to cancer care are important since&#xD;
        previous work has indicated that when equal access to RT in Radiation Therapy Oncology Group&#xD;
        (RTOG) prospective randomized trials is granted, race does not independently affect outcomes,&#xD;
        a finding similar to work conducted in Level I evidence-proven optimal management of curable&#xD;
        neurologic conditions. Breast cancer is the most common cancer in African-American women and&#xD;
        Prostate cancer is the most common cancer in African-American men. African-American breast &amp;&#xD;
        prostate cancer participants are less likely to receive standard-of-care radiation therapy.&#xD;
  &#xD;
        Previous work has identified that compared to Caucasian women with breast cancer,&#xD;
        African-American women are 48% more likely to have RT omission during treatment, 167% less&#xD;
        likely to receive timely completion of RT after breast-conserving surgery, 40% less likely to&#xD;
        complete RT, and significantly more likely to experience RT treatment delays. Shorter course&#xD;
        radiation therapy may reduce disparities in radiation therapy care facing African-American&#xD;
        breast cancer participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">July 11, 2028</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2027</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>Evaluation of barriers to navigator access</measure>
      <time_frame>Immediately following radiotherapy treatment</time_frame>
      <description>Survey-based methods will be used to assess barriers facing under-represented minority cancer patient access to patient navigation. This study will use a patient-completed, culturally sensitive survey adapted from &quot;Walking Forward,&quot; a patient navigator program providing culturally appropriate community education on cancer, screening and treatment, to include barriers to specific RT regimens, and concerns regarding transportation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Assess the impact of patient navigation on patient access to radiation oncology care</measure>
      <time_frame>Immediately following radiotherapy treatment</time_frame>
      <description>Qualitative mechanisms will be used to assess the impact of patient navigation on patient access to radiation oncology care and consequently utilization of standard of care modalities. This study will use patient-completed surveys to evaluate the impact of patient navigation on access to short-course RT by using a culturally sensitive survey adapted from &quot;Walking Forward&quot;, a patient navigator program providing culturally appropriate community education on cancer, screening and treatmen. The feedback provided by patients on the impact of patient navigation will be compared- before and after RT, and will also be compared against feedback from patients who did not received patient navigation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minority financial toxicity differences</measure>
      <time_frame>Immediately following radiotherapy treatment</time_frame>
      <description>This study will use patient-completed surveys to evaluate the impact of financial hardship in African-American breast cancer patients. Patient scores from an evidence-based tool, &quot;The COmprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT)&quot; will be used to compare financial hardship in each group of patients with early-stage breast cancer who have received a lumpectomy. Surveys will investigate differences in financial toxicity survery scores experienced by underrepresented minorities receiving conventional versus short-course RT.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Breast Cancer</condition>
    <condition>Prostate Cancer</condition>
    <arm_group>
      <arm_group_label>Navigator-Assisted Hypofractionation (NAVAH)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>This pilot cohort study is designed as follows:&#xD;
  Navigator discussion with patients prior to the start of radiation therapy simulation (15-30 minutes).&#xD;
  Navigator administration of survey with patients after completion of radiation therapy simulation but before the start of radiation therapy (30-45 minutes)&#xD;
  Navigator administration of post-treatment survey and financial toxicity survey instrument after the completion of radiation therapy (60 minutes).</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>NAVAH</intervention_name>
      <description>Patient navigator program that aims to inform African-American prostate and breast cancer patients about their treatment options, specifically radiotherapy</description>
      <arm_group_label>Navigator-Assisted Hypofractionation (NAVAH)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects must have histologically or cytologically confirmed Breast or Prostate&#xD;
               Cancer.&#xD;
  &#xD;
            -  Subjects must be Age &gt;18 years. This study requires informed consent by the subject;&#xD;
               as children are not able to perform this without parental approval, subjects &lt; age 18&#xD;
               are excluded from this study.&#xD;
  &#xD;
            -  Subjects must be of African - American race.&#xD;
  &#xD;
            -  Subjects must have the ability to understand and the willingness to sign a written&#xD;
               informed consent document.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subjects NOT of African - American ethnicity.&#xD;
  &#xD;
            -  Subjects WITHOUT histologically or cytologically confirmed Breast or Prostate Cancer.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shearwood McClelland III, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University Hospitals Cleveland Medical Center Seidman Cancer Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shearwood McClelland III, MD</last_name>
      <phone>216-702-8700</phone>
      <email>Shearwood.mcclelland@uhhospitals.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Shearwood McClelland III, MD</last_name>
        <phone>216-702-8700</phone>
        <email>Shearwood.mcclelland@uhhospitals.org</email>
      </contact>
      <investigator>
        <last_name>Shearwood McClelland III, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>June 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Radiation Therapy</keyword>
    <keyword>Navigator-Assisted Hypofractionation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Prostatic Neoplasms</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05978232
  org study id: CASE1123
  nct id: NCT05978232
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  African-Americans have disparately limited access to optimal cancer care. They have the
        highest overall cancer death rate and shortest survival time of any racial or ethnic group in
        the United States. Elucidation of disparities in access to cancer care are important since
        previous work has indicated that when equal access to RT in Radiation Therapy Oncology Group
        (RTOG) prospective randomized trials is granted, race does not independently affect outcomes,
        a finding similar to work conducted in Level I evidence-proven optimal management of curable
        neurologic conditions. Breast cancer is the most common cancer in African-American women and
        Prostate cancer is the most common cancer in African-American men. African-American breast &
        prostate cancer participants are less likely to receive standard-of-care radiation therapy.
  
        Previous work has identified that compared to Caucasian women with breast cancer,
        African-American women are 48% more likely to have RT omission during treatment, 167% less
        likely to receive timely completion of RT after breast-conserving surgery, 40% less likely to
        complete RT, and significantly more likely to experience RT treatment delays. Shorter course
        radiation therapy may reduce disparities in radiation therapy care facing African-American
        breast cancer participants.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Evaluation of barriers to navigator access
  time frame: Immediately following radiotherapy treatment
  description: Survey-based methods will be used to assess barriers facing under-represented minority cancer patient access to patient navigation. This study will use a patient-completed, culturally sensitive survey adapted from "Walking Forward," a patient navigator program providing culturally appropriate community education on cancer, screening and treatment, to include barriers to specific RT regimens, and concerns regarding transportation.
  measure: Assess the impact of patient navigation on patient access to radiation oncology care
  time frame: Immediately following radiotherapy treatment
  description: Qualitative mechanisms will be used to assess the impact of patient navigation on patient access to radiation oncology care and consequently utilization of standard of care modalities. This study will use patient-completed surveys to evaluate the impact of patient navigation on access to short-course RT by using a culturally sensitive survey adapted from "Walking Forward", a patient navigator program providing culturally appropriate community education on cancer, screening and treatmen. The feedback provided by patients on the impact of patient navigation will be compared- before and after RT, and will also be compared against feedback from patients who did not received patient navigation.
  measure: Minority financial toxicity differences
  time frame: Immediately following radiotherapy treatment
  description: This study will use patient-completed surveys to evaluate the impact of financial hardship in African-American breast cancer patients. Patient scores from an evidence-based tool, "The COmprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy (COST-FACIT)" will be used to compare financial hardship in each group of patients with early-stage breast cancer who have received a lumpectomy. Surveys will investigate differences in financial toxicity survery scores experienced by underrepresented minorities receiving conventional versus short-course RT.
  arm group label: Navigator-Assisted Hypofractionation (NAVAH)
  arm group type: Experimental
  description: This pilot cohort study is designed as follows:
  Navigator discussion with patients prior to the start of radiation therapy simulation (15-30 minutes).
  Navigator administration of survey with patients after completion of radiation therapy simulation but before the start of radiation therapy (30-45 minutes)
  Navigator administration of post-treatment survey and financial toxicity survey instrument after the completion of radiation therapy (60 minutes).
  intervention type: Behavioral
  intervention name: NAVAH
  description: Patient navigator program that aims to inform African-American prostate and breast cancer patients about their treatment options, specifically radiotherapy
  arm group label: Navigator-Assisted Hypofractionation (NAVAH)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Shearwood McClelland III, MD
  role: Principal Investigator
  affiliation: University Hospitals Cleveland Medical Center Seidman Cancer Center
  last name: Shearwood McClelland III, MD
  phone: 216-702-8700
  email: Shearwood.mcclelland@uhhospitals.org
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Prostatic Neoplasms