<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/NCT04486846</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00104751</org_study_id>
    <nct_id>NCT04486846</nct_id>
  </id_info>
  <brief_title>Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)</brief_title>
  <official_title>Evaluation of an Electronic Post-Treatment Surveillance Program for Prostate Cancer Survivors (eHealth)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</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>
      The purpose of this single institution pilot study is to determine the feasibility of&#xD;
      implementing an eHealth prostate cancer surveillance program through the eVisit electronic&#xD;
      medical record patient portal. The investigators will assess patient compliance and&#xD;
      satisfaction with eVisit follow up care in lieu of in person clinic visits.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Telehealth offers the opportunity to transform cancer surveillance into a patient-centered&#xD;
      effort with shared leadership between patient and oncologist. Peer-to-peer electronic&#xD;
      communications can improve the collaboration between oncologist and primary care provider&#xD;
      (PCP) as patients transition back to primary care as their primary health provider. The&#xD;
      investigators propose to test a patient-centered eHealth surveillance program utilizing novel&#xD;
      asynchronous telehealth tools to provide patient-reported outcome symptom monitoring using&#xD;
      the electronic medical record's patient portal (eVisit).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Principal Investigator left Duke University&#xD;
  </why_stopped>
  <start_date type="Anticipated">June 2021</start_date>
  <completion_date type="Anticipated">March 2022</completion_date>
  <primary_completion_date type="Anticipated">March 2022</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>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients who complete all scheduled eVisits at the end of follow-up</measure>
    <time_frame>12 months</time_frame>
    <description>Defined as completion of labwork and at least 80% of the questions asked at each eVisit</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of enrollment to the eVisit program</measure>
    <time_frame>12 months</time_frame>
    <description>Defined as the percentage of patients who are approached for eVisit and ultimately enroll</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>eVisit participant reported satisfaction</measure>
    <time_frame>12 months</time_frame>
    <description>Reported as the summary score from validated Brief Patient Satisfaction 10-item scale instrument assessed from &quot;1/strongly agree&quot; through &quot;5/strongly disagree&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with cancer treatment related toxicities</measure>
    <time_frame>12 months</time_frame>
    <description>Defined specifically as CTCAE Grade 2 or higher GI, GU, hormonal, and sexual toxicities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of eVisit participants with cancer recurrence</measure>
    <time_frame>12 months</time_frame>
    <description>Defined as biochemical progression (PSA &gt;0.2 ng/ml for prostatectomy patients or nadir + 2 ng/ml for radiation patients) or metastasis (by imaging)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Financial impact of the eVisit program on participants compared to in person follow up clinic visits</measure>
    <time_frame>12 months</time_frame>
    <description>Defined by the financial burden assessment completed by participants, scored from &quot;0/not at all&quot; through &quot;4/very much&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up</measure>
    <time_frame>12 months</time_frame>
    <description>Defined by percentage of participants/eVisits covered by insurance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up</measure>
    <time_frame>12 months</time_frame>
    <description>Defined by qualitative analysis of time commitment for providers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up</measure>
    <time_frame>12 months</time_frame>
    <description>Defined by qualitative analysis of reimbursement process</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>eVisit</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study intervention will be an electronically performed surveillance program replacing face-to-face clinic follow-up visits. At 3 month intervals for 1 year, the patient will receive an email reminder generated by the patient portal to complete lab testing and eVisit questionnaire.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>eVisit</intervention_name>
    <description>electronic surveillance program in lieu of in-person clinic visit</description>
    <arm_group_label>eVisit</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ≥ 18 years old with histologically confirmed prostate cancer&#xD;
&#xD;
          -  Completed curative intent treatment to the prostate +/- pelvis&#xD;
&#xD;
          -  Deemed to be &quot;without evidence of active disease&quot; by treating provider with at least 1&#xD;
             follow up visit 3 or more months after treatment completion&#xD;
&#xD;
          -  MyChart account or willingness to open account&#xD;
&#xD;
          -  Access to the internet&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Documented extrapelvic metastases&#xD;
&#xD;
          -  PSA meeting definition of recurrence (&gt;0.2 ng/ml for prostatectomy patients or nadir +&#xD;
             2 ng/ml for radiation patients) and rising with doubling time less than 1 year&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bridget Koontz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Cancer Institute Cary</name>
      <address>
        <city>Cary</city>
        <state>North Carolina</state>
        <zip>27518</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Durham Regional Hospital</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Duke Raleigh Hospital</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27609</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>June 7, 2021</last_update_submitted>
  <last_update_submitted_qc>June 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT04486846
org study id: Pro00104751
nct id: NCT04486846
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this single institution pilot study is to determine the feasibility of
      implementing an eHealth prostate cancer surveillance program through the eVisit electronic
      medical record patient portal. The investigators will assess patient compliance and
      satisfaction with eVisit follow up care in lieu of in person clinic visits.
Telehealth offers the opportunity to transform cancer surveillance into a patient-centered
      effort with shared leadership between patient and oncologist. Peer-to-peer electronic
      communications can improve the collaboration between oncologist and primary care provider
      (PCP) as patients transition back to primary care as their primary health provider. The
      investigators propose to test a patient-centered eHealth surveillance program utilizing novel
      asynchronous telehealth tools to provide patient-reported outcome symptom monitoring using
      the electronic medical record's patient portal (eVisit).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Proportion of patients who complete all scheduled eVisits at the end of follow-up
time frame: 12 months
description: Defined as completion of labwork and at least 80% of the questions asked at each eVisit
measure: Feasibility of enrollment to the eVisit program
time frame: 12 months
description: Defined as the percentage of patients who are approached for eVisit and ultimately enroll
measure: eVisit participant reported satisfaction
time frame: 12 months
description: Reported as the summary score from validated Brief Patient Satisfaction 10-item scale instrument assessed from "1/strongly agree" through "5/strongly disagree"
measure: Number of participants with cancer treatment related toxicities
time frame: 12 months
description: Defined specifically as CTCAE Grade 2 or higher GI, GU, hormonal, and sexual toxicities
measure: Number of eVisit participants with cancer recurrence
time frame: 12 months
description: Defined as biochemical progression (PSA >0.2 ng/ml for prostatectomy patients or nadir + 2 ng/ml for radiation patients) or metastasis (by imaging)
measure: Financial impact of the eVisit program on participants compared to in person follow up clinic visits
time frame: 12 months
description: Defined by the financial burden assessment completed by participants, scored from "0/not at all" through "4/very much"
measure: Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
time frame: 12 months
description: Defined by percentage of participants/eVisits covered by insurance
measure: Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
time frame: 12 months
description: Defined by qualitative analysis of time commitment for providers
measure: Financial impact of the eVisit program on Duke University Hospital (institution) compared to in person follow up
time frame: 12 months
description: Defined by qualitative analysis of reimbursement process
arm group label: eVisit
arm group type: Experimental
description: The study intervention will be an electronically performed surveillance program replacing face-to-face clinic follow-up visits. At 3 month intervals for 1 year, the patient will receive an email reminder generated by the patient portal to complete lab testing and eVisit questionnaire.
intervention type: Other
intervention name: eVisit
description: electronic surveillance program in lieu of in-person clinic visit
arm group label: eVisit
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bridget Koontz, MD
role: Principal Investigator
affiliation: Duke Health
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
sharing ipd: No