<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/NCT03028584</url>
  </required_header>
  <id_info>
    <org_study_id>UW16029</org_study_id>
    <secondary_id>P30CA014520</secondary_id>
    <secondary_id>2016-0760</secondary_id>
    <secondary_id>A534260</secondary_id>
    <secondary_id>SMPH\MEDICINE\HEM-ONC</secondary_id>
    <nct_id>NCT03028584</nct_id>
  </id_info>
  <brief_title>Survivorship Care Plans in a Community Oncology Practice</brief_title>
  <official_title>Feasibility of Delivering Electronic Health Record (EHR)-Based Survivorship Care Plans and Planning to Cancer Survivors in a Community Oncology Practice</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Wisconsin, Madison</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Wisconsin, Madison</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a two part observational study evaluating the feasibility of implementing an&#xD;
      EHR-based model within a community oncology practice.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part 1: The research team will use a sociotechnical work systems model, developed by&#xD;
      researchers at the University of Wisconsin (UW) Systems Engineering Initiative for Patience&#xD;
      Safety (SEIPS), to guide analysis of the work system barriers and facilitators to&#xD;
      implementing an EHR-based care planning model in community oncology practice, collected from&#xD;
      direct observations.&#xD;
&#xD;
      Part 2: The research team will measure reach/maintenance (percentage of survivors with&#xD;
      EHR-based survivorship care plans (SCPs) over a 9-month time period) and impact (pre/post&#xD;
      survey of patient satisfaction and perceived care coordination).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">March 23, 2018</completion_date>
  <primary_completion_date type="Actual">February 28, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>EHR-based SCPs and care planning</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Asses whether barriers to EHR-based SCPs and care planning have been mitigated, based on clinician survey.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility of providing EHR-based care planning, measured by SCP provision rates</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Measured by SCP provision rates (percentage of survivors with EHR-based SCPs)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Feasibility of providing EHR-based care planning, measured by the EHR</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Measured by survivor access to SCPs, per the EHR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported change in satisfaction, using survey</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>The impact of providing EHR-based care planning measured in change of satisfaction with perceived care coordination (assessed prior to and at 4 weeks after SCP provision)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of providing EHR-based care planning</measure>
    <time_frame>Up to 2 years</time_frame>
    <description>Measured by reported SCP usability, usefulness, and content (assessed prior to and at 4 weeks after SCP provision)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">30</enrollment>
  <condition>Breast Cancer</condition>
  <condition>Prostate Cancer</condition>
  <condition>Colorectal Cancer</condition>
  <arm_group>
    <arm_group_label>Clinicians</arm_group_label>
    <description>Observe up to N=10 clinicians. Observations will include:&#xD;
Oncology history and care plan development by clinicians including use of EHR technology to develop care plans and methods used to secure necessary information for care plan creation&#xD;
Provision and coordination of survivorship care occurring during care team meetings, discussions among clinicians, and survivor visits with clinicians, especially visits in which a care plan is provided to a survivor&#xD;
Clinician seeking survivorship related information or resources through use of technology or discussion with other clinicians&#xD;
Survivorship work or tasks performed by the clinician including adding, modifying or extracting information from the EHR and adding or modifying information in the care plan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinicians and Patients</arm_group_label>
    <description>Surveys of N=30 breast cancer, colon cancer, and prostate cancer patients. Subjects will complete 1st survey electronically in-clinic. Subjects will either be e-mailed or mailed a survey at 4 weeks.&#xD;
Survey of clinicians will be sent via e-mail.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>Subjects (cancer patients and clinicians) will complete up to 2 surveys.</description>
    <arm_group_label>Clinicians</arm_group_label>
    <arm_group_label>Clinicians and Patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Clinicians who provide care for breast, colon, or prostate patients.&#xD;
&#xD;
        Cancer patients/survivors of breast cancer (BrCa), prostate (PrCa), or colorectal (CRCa)&#xD;
        cancer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinicians: Provide cancer care to BrCa, CRCa or PrCa&#xD;
&#xD;
          -  Clinicians: Are a physician, advanced practice practitioner, nurse, or equivalent&#xD;
&#xD;
          -  Patients: Have a diagnosis of breast, colorectal, or prostate cancer for which and&#xD;
             EHR-based SCP will be provided&#xD;
&#xD;
          -  Patients: Have been treated with curative intent (e.g. surgery, chemotherapy and/or&#xD;
             radiation therapy) for a Stage 1-3 cancer diagnosis&#xD;
&#xD;
          -  Patients: Have received some part of active cancer treatment&#xD;
&#xD;
          -  Patients: Have complete active treatment (defined as surgery, chemotherapy, and/or&#xD;
             radiation therapy). HER2-based and endocrine therapies may be ongoing and do NOT need&#xD;
             to have been completed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to complete or unwilling to answer questions in English&#xD;
&#xD;
          -  Patients: Received all active cancer treatment elsewhere (e.g. &quot;observation - only&quot;&#xD;
             patients)&#xD;
&#xD;
          -  Patients: Have metastatic cancer&#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>Amyé Tevaarwerk, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mary Sesto, PT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Wisconsin, Madison</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UW Cancer Center at ProHealth Care</name>
      <address>
        <city>Waukesha</city>
        <state>Wisconsin</state>
        <zip>53188</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://cancer.wisc.edu/</url>
    <description>UW Carbone Cancer Center Home Page</description>
  </link>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>November 10, 2016</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>November 14, 2019</last_update_submitted>
  <last_update_submitted_qc>November 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>BrCa</keyword>
  <keyword>PrCa</keyword>
  <keyword>CRCa</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal 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/NCT03028584
org study id: UW16029
secondary id: P30CA014520
secondary id: 2016-0760
secondary id: A534260
secondary id: SMPH\MEDICINE\HEM-ONC
nct id: NCT03028584
lead sponsor: 
collaborator: 
has dmc: Yes
This is a two part observational study evaluating the feasibility of implementing an
      EHR-based model within a community oncology practice.
Part 1: The research team will use a sociotechnical work systems model, developed by
      researchers at the University of Wisconsin (UW) Systems Engineering Initiative for Patience
      Safety (SEIPS), to guide analysis of the work system barriers and facilitators to
      implementing an EHR-based care planning model in community oncology practice, collected from
      direct observations.

      Part 2: The research team will measure reach/maintenance (percentage of survivors with
      EHR-based survivorship care plans (SCPs) over a 9-month time period) and impact (pre/post
      survey of patient satisfaction and perceived care coordination).
observational model: Case-Only
time perspective: Prospective
measure: EHR-based SCPs and care planning
time frame: Up to 2 years
description: Asses whether barriers to EHR-based SCPs and care planning have been mitigated, based on clinician survey.
measure: Feasibility of providing EHR-based care planning, measured by SCP provision rates
time frame: Up to 2 years
description: Measured by SCP provision rates (percentage of survivors with EHR-based SCPs)
measure: Feasibility of providing EHR-based care planning, measured by the EHR
time frame: Up to 2 years
description: Measured by survivor access to SCPs, per the EHR
measure: Self-reported change in satisfaction, using survey
time frame: Up to 2 years
description: The impact of providing EHR-based care planning measured in change of satisfaction with perceived care coordination (assessed prior to and at 4 weeks after SCP provision)
measure: Impact of providing EHR-based care planning
time frame: Up to 2 years
description: Measured by reported SCP usability, usefulness, and content (assessed prior to and at 4 weeks after SCP provision)
arm group label: Clinicians
description: Observe up to N=10 clinicians. Observations will include:
Oncology history and care plan development by clinicians including use of EHR technology to develop care plans and methods used to secure necessary information for care plan creation
Provision and coordination of survivorship care occurring during care team meetings, discussions among clinicians, and survivor visits with clinicians, especially visits in which a care plan is provided to a survivor
Clinician seeking survivorship related information or resources through use of technology or discussion with other clinicians
Survivorship work or tasks performed by the clinician including adding, modifying or extracting information from the EHR and adding or modifying information in the care plan
arm group label: Clinicians and Patients
description: Surveys of N=30 breast cancer, colon cancer, and prostate cancer patients. Subjects will complete 1st survey electronically in-clinic. Subjects will either be e-mailed or mailed a survey at 4 weeks.
Survey of clinicians will be sent via e-mail.
intervention type: Behavioral
intervention name: Survey
description: Subjects (cancer patients and clinicians) will complete up to 2 surveys.
arm group label: Clinicians
arm group label: Clinicians and Patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Amyé Tevaarwerk, MD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
last name: Mary Sesto, PT, PhD
role: Principal Investigator
affiliation: University of Wisconsin, Madison
facility: 
country: United States
url: https://cancer.wisc.edu/
description: UW Carbone Cancer Center Home Page
responsible party type: Sponsor
mesh term: Colorectal Neoplasms