<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/NCT03271099</url>
  </required_header>
  <id_info>
    <org_study_id>H-36781</org_study_id>
    <nct_id>NCT03271099</nct_id>
  </id_info>
  <brief_title>Patient Navigation in Cancer Survivorship at a Safety Net Institution</brief_title>
  <official_title>Patient Navigation as Part of the Cancer Survivorship Care Plan at a Safety Net Institution</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harvard Pilgrim Health Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>No</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>
      This study seeks to enroll patients receiving a Survivorship Care Plan following curative&#xD;
      therapy for cancer. Participants will be randomly assigned to receive usual care or to be&#xD;
      followed by a Patient Navigator as part of their Survivorship Care Plan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study seeks to enroll patients receiving a Survivorship Care Plan following curative&#xD;
      therapy for cancer. Participants will be randomly assigned to receive usual care or to be&#xD;
      followed by a Patient Navigator as part of their Survivorship Care Plan.&#xD;
&#xD;
      Study participation for all participants will be for up to 9 months, with study visits&#xD;
      approximately every 3 months, based on standard clinical follow-up. All participants will be&#xD;
      administered quality of life surveys by a Clinical Research Associate at study entry,&#xD;
      mid-study (approximately 3-6 months) and at study completion.&#xD;
&#xD;
      The following factors will be compared between arms:&#xD;
&#xD;
        -  Missed/kept appointments&#xD;
&#xD;
        -  Use of urgent/emergent care&#xD;
&#xD;
        -  Quality of Life in relation to survivorship care&#xD;
&#xD;
        -  Participants lost to care&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 16, 2017</start_date>
  <completion_date type="Actual">September 10, 2020</completion_date>
  <primary_completion_date type="Actual">September 10, 2020</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Missed appointments</measure>
    <time_frame>9 months</time_frame>
    <description>The research team will document the number of cancer care appointments scheduled and of those, how many appointments were missed (obtained by medical record and by patient report in case a visit was outside of study institution).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Urgent/emergent care</measure>
    <time_frame>9 months</time_frame>
    <description>The research team will document the number of urgent/emergent care visits attended within the study period of 9 months (obtained by medical record and by patient report in case a visit was outside of study institution).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer Needs Distress</measure>
    <time_frame>9 months</time_frame>
    <description>Participants will rate their feelings about 39 specific cancer needs on a 5 point scale from &quot;Not a Problem&quot; to &quot;Very Severe Problem&quot; using the Cancer Needs Distress Inventory (CaNDI) tool. Total scores can range from 39 to 195. Lower scores are associated with less cancer related distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New Survivor Survey</measure>
    <time_frame>9 months</time_frame>
    <description>Participants will rate their understanding about 16 specific aspects of survivorship care on a 4 point scale from &quot;Strongly Disagree&quot; to &quot;Strongly Agree&quot; using the Preparing for Life as a New Survivor (PLANS) Scale. Total scores can range from 16 to 48. Lower scores are associated with less understanding of the survivorship care process.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lost to Care</measure>
    <time_frame>9 months</time_frame>
    <description>The research team will document the number of participants lost to care, based on consecutive missed cancer care visits.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Navigator</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient navigator services provided as part of survivorship care plan</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Navigator</intervention_name>
    <description>Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance</description>
    <arm_group_label>Navigator</arm_group_label>
    <other_name>navigation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Stage I, II, III or IVa Cancer diagnosis (may include Solitary plasmacytoma, Diffuse&#xD;
             Large B-Cell Lymphoma (DLBCL), ductal carcinoma in situ (DCIS) of the breast)&#xD;
&#xD;
          -  Completed treatment with curative intent within the past 12 months. (May be on&#xD;
             maintenance therapy.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Distant Metastatic disease&#xD;
&#xD;
          -  Non-curable disease&#xD;
&#xD;
          -  Recurrence of disease prior to enrollment&#xD;
&#xD;
          -  Require ongoing navigation from the treatment navigator&#xD;
&#xD;
          -  Enrolled/active in another randomized study (Project SUPPORT)&#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>Minh Tam Truong, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>September 7, 2021</last_update_submitted>
  <last_update_submitted_qc>September 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>survivorship; navigation</keyword>
  <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/NCT03271099
org study id: H-36781
nct id: NCT03271099
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study seeks to enroll patients receiving a Survivorship Care Plan following curative
      therapy for cancer. Participants will be randomly assigned to receive usual care or to be
      followed by a Patient Navigator as part of their Survivorship Care Plan.
This study seeks to enroll patients receiving a Survivorship Care Plan following curative
      therapy for cancer. Participants will be randomly assigned to receive usual care or to be
      followed by a Patient Navigator as part of their Survivorship Care Plan.

      Study participation for all participants will be for up to 9 months, with study visits
      approximately every 3 months, based on standard clinical follow-up. All participants will be
      administered quality of life surveys by a Clinical Research Associate at study entry,
      mid-study (approximately 3-6 months) and at study completion.

      The following factors will be compared between arms:

        -  Missed/kept appointments

        -  Use of urgent/emergent care

        -  Quality of Life in relation to survivorship care

        -  Participants lost to care
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Missed appointments
time frame: 9 months
description: The research team will document the number of cancer care appointments scheduled and of those, how many appointments were missed (obtained by medical record and by patient report in case a visit was outside of study institution).
measure: Urgent/emergent care
time frame: 9 months
description: The research team will document the number of urgent/emergent care visits attended within the study period of 9 months (obtained by medical record and by patient report in case a visit was outside of study institution).
measure: Cancer Needs Distress
time frame: 9 months
description: Participants will rate their feelings about 39 specific cancer needs on a 5 point scale from "Not a Problem" to "Very Severe Problem" using the Cancer Needs Distress Inventory (CaNDI) tool. Total scores can range from 39 to 195. Lower scores are associated with less cancer related distress.
measure: New Survivor Survey
time frame: 9 months
description: Participants will rate their understanding about 16 specific aspects of survivorship care on a 4 point scale from "Strongly Disagree" to "Strongly Agree" using the Preparing for Life as a New Survivor (PLANS) Scale. Total scores can range from 16 to 48. Lower scores are associated with less understanding of the survivorship care process.
measure: Lost to Care
time frame: 9 months
description: The research team will document the number of participants lost to care, based on consecutive missed cancer care visits.
arm group label: Usual Care
arm group type: No Intervention
description: Usual care
arm group label: Navigator
arm group type: Experimental
description: Patient navigator services provided as part of survivorship care plan
intervention type: Other
intervention name: Navigator
description: Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance
arm group label: Navigator
other name: navigation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Minh Tam Truong, MD
role: Principal Investigator
affiliation: Boston Medical Center
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No