<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/NCT02186444</url>
  </required_header>
  <id_info>
    <org_study_id>MCC-17455</org_study_id>
    <nct_id>NCT02186444</nct_id>
  </id_info>
  <brief_title>Navigator Guided e-Psychoeducational Intervention</brief_title>
  <official_title>Navigator Guided e-Psychoeducational Intervention for Prostate Cancer Patients and Their Caregivers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>H. Lee Moffitt Cancer Center and Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>H. Lee Moffitt Cancer Center and Research Institute</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>
      The purpose of this study is to evaluate the impact of providing newly diagnosed prostate&#xD;
      cancer patients and their caregivers with an interactive mobile tablet technology-based&#xD;
      application delivered by a community navigator versus providing National Cancer Institute&#xD;
      (NCI) information booklets delivered by a Community Navigator (CN) on patient outcomes&#xD;
      (decisional satisfaction, quality of life, knowledge, decisional conflict) and shared&#xD;
      decision making practices (decision making involvement).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2014</start_date>
  <completion_date type="Actual">August 17, 2017</completion_date>
  <primary_completion_date type="Actual">December 30, 2016</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>Final Survey Results per Study Arm</measure>
    <time_frame>6 months post baseline survey</time_frame>
    <description>Investigators plan to assess if the psycho-educational intervention, PHIN, delivered by a CN is more efficacious as compared to NCI Information Booklets (IB) delivered by a CN. Participants will be asked to complete a baseline set of surveys and follow-up surveys at three additional time points: (1) 6 weeks after receiving the educational intervention; (2) after the follow-up decision with their doctor or health care provider; and (3) 6 months after the baseline surveys were done.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">391</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>PHI Navigator</arm_group_label>
    <description>Personalized Health Information Navigator (PHIN).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NCI Information Booklets (IB)</arm_group_label>
    <description>National Cancer Institute (NCI) Information Booklets (IB).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Personalized Health Information Navigator (PHIN)</intervention_name>
    <description>The application (or &quot;app&quot;) titled Personalized Health Information Navigator (PHIN) is an interactive psycho-educational intervention that will be delivered via mobile tablet technology. The PHIN provides patient-centered education. At the first meeting, the community navigator will provide a visual demonstration of PHIN on the Apple iPad. The community navigator will leave the iPad with the participant for 6-weeks and will stress the importance of using the PHIN app to address any educational or psychosocial needs.</description>
    <arm_group_label>PHI Navigator</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NCI Information Booklets (IB)</intervention_name>
    <description>Participants will receive a packet of information booklets (&quot;What You Need to Know About Prostate Cancer&quot;; &quot;Taking Time: Support for People with Cancer&quot;; and &quot;Facing Forward, Life After Cancer Treatment&quot;) that address prostate cancer treatment options, the late and long term effects, follow-up care, and sources of support. At the first meeting, the community navigator will provide a review of the print materials and stress the importance of reading the booklets carefully to help prepare for the discussion with your healthcare provider. The community navigator will leave the print materials with the participant for 6-weeks.</description>
    <arm_group_label>NCI Information Booklets (IB)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients from Moffitt Cancer Center Genitourinary Clinic, University of South Florida&#xD;
        Genitourinary Clinic, or community-based urologists and primary care providers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men newly diagnosed (within 6 months) with biopsy confirmed case of prostate cancer&#xD;
&#xD;
          -  40 - 80 years of age&#xD;
&#xD;
          -  Able to speak and read English&#xD;
&#xD;
          -  Live within 120 miles of a healthcare treatment facility&#xD;
&#xD;
          -  Have no documented or observable visual, auditory, psychiatric, or neurological&#xD;
             disorders that would interfere with study participation&#xD;
&#xD;
          -  Be able to complete telephone interviews&#xD;
&#xD;
          -  Have not completed the first course of treatment&#xD;
&#xD;
          -  Have a family member/caregiver willing to participate&#xD;
&#xD;
          -  Capable of providing written consent for study participation. Men diagnosed with early&#xD;
             stage, locally advanced or metastatic disease or men who are on active surveillance&#xD;
             will be eligible to participate in this study.&#xD;
&#xD;
          -  Caregiver must be aged 18 or older&#xD;
&#xD;
          -  Caregiver must be identified by patient as their caregiver (i.e., provider of&#xD;
             emotional and/or physical care)&#xD;
&#xD;
          -  Caregiver must have not been diagnosed with cancer in the previous year or be&#xD;
             receiving cancer treatment&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>B. Lee Green, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>H. Lee Moffitt Cancer Center and Research Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>H. Lee Moffitt Cancer and Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 2, 2014</study_first_submitted>
  <study_first_submitted_qc>July 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 10, 2014</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>newly diagnosed prostate cancer</keyword>
  <keyword>prostate</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>


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/NCT02186444
org study id: MCC-17455
nct id: NCT02186444
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the impact of providing newly diagnosed prostate
      cancer patients and their caregivers with an interactive mobile tablet technology-based
      application delivered by a community navigator versus providing National Cancer Institute
      (NCI) information booklets delivered by a Community Navigator (CN) on patient outcomes
      (decisional satisfaction, quality of life, knowledge, decisional conflict) and shared
      decision making practices (decision making involvement).
observational model: Cohort
time perspective: Prospective
measure: Final Survey Results per Study Arm
time frame: 6 months post baseline survey
description: Investigators plan to assess if the psycho-educational intervention, PHIN, delivered by a CN is more efficacious as compared to NCI Information Booklets (IB) delivered by a CN. Participants will be asked to complete a baseline set of surveys and follow-up surveys at three additional time points: (1) 6 weeks after receiving the educational intervention; (2) after the follow-up decision with their doctor or health care provider; and (3) 6 months after the baseline surveys were done.
arm group label: PHI Navigator
description: Personalized Health Information Navigator (PHIN).
arm group label: NCI Information Booklets (IB)
description: National Cancer Institute (NCI) Information Booklets (IB).
intervention type: Other
intervention name: Personalized Health Information Navigator (PHIN)
description: The application (or "app") titled Personalized Health Information Navigator (PHIN) is an interactive psycho-educational intervention that will be delivered via mobile tablet technology. The PHIN provides patient-centered education. At the first meeting, the community navigator will provide a visual demonstration of PHIN on the Apple iPad. The community navigator will leave the iPad with the participant for 6-weeks and will stress the importance of using the PHIN app to address any educational or psychosocial needs.
arm group label: PHI Navigator
intervention type: Other
intervention name: NCI Information Booklets (IB)
description: Participants will receive a packet of information booklets ("What You Need to Know About Prostate Cancer"; "Taking Time: Support for People with Cancer"; and "Facing Forward, Life After Cancer Treatment") that address prostate cancer treatment options, the late and long term effects, follow-up care, and sources of support. At the first meeting, the community navigator will provide a review of the print materials and stress the importance of reading the booklets carefully to help prepare for the discussion with your healthcare provider. The community navigator will leave the print materials with the participant for 6-weeks.
arm group label: NCI Information Booklets (IB)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Male
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: B. Lee Green, PhD
role: Principal Investigator
affiliation: H. Lee Moffitt Cancer Center and Research Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms