<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/NCT02974634</url>
  </required_header>
  <id_info>
    <org_study_id>826150</org_study_id>
    <nct_id>NCT02974634</nct_id>
  </id_info>
  <brief_title>Ostomy Telehealth For Cancer Survivors</brief_title>
  <acronym>PCORI</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>City of Hope Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yale University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Arizona</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to test the benefits of an educational program, the Ostomy&#xD;
      Self-Management Training (OSMT) program, for improving patient activation (preparedness to do&#xD;
      self-care), self-efficacy (patients' ability to do self-care), knowledge of ostomy/urostomy&#xD;
      self-care, quality of life, mood, use of medical services, and financial burden in patients&#xD;
      with ostomies. The study will compare patients in the intervention (training) group and&#xD;
      patients in the usual care group.&#xD;
&#xD;
      Subjects' participation in this study is expected to last about 7 months. The PI plans to&#xD;
      enroll up to 176 subjects at 3 hospitals (University of Pennsylvania, Yale University School&#xD;
      of Nursing, and City of Hope in Los Angeles). All patient telehealth education will be&#xD;
      coordinated by the University of Arizona in Tucson, Arizona.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Over one million individuals in the U.S. have ostomies. The American Cancer Society estimates&#xD;
      39,610 rectal cancer cases and 74,000 bladder cancer cases will be diagnosed in 2015. Of&#xD;
      these, at least 30,000 will receive ostomies, and an additional unknown number due to&#xD;
      gynecologic, other gastrointestinal tumors. The HRQOL impact is tremendous and greater than&#xD;
      with many other cancer treatments. An ostomy is often a prolonged or lifelong disabling&#xD;
      problem for cancer survivors. The adaptation period is quite variable. 18% of participants&#xD;
      took at least one year, or never felt comfortable, in their ostomy care. Importantly, many&#xD;
      patients cannot attend selfmanagement programs or patient groups for a myriad of reasons,&#xD;
      including distance to travel, monetary outlays, comorbidities making travel difficult, or&#xD;
      lack of access to transportation. In addition, a national shortage of OCNs means patients&#xD;
      with an ostomy, whether newly placed or a long-term issue, receive little help.&#xD;
&#xD;
      It is imperative to study interventions for these cancer survivors aimed to limit family&#xD;
      financial burdens, decrease medical care use, and improve well-being. This study has the&#xD;
      potential to improve health care outcomes for cancer survivors with ostomies by enhancing&#xD;
      their knowledge of and self-efficacy with ostomy care. This will be accomplished by improving&#xD;
      the ability to communicate an established educational curriculum developed based on patient&#xD;
      needs and desires and refined via a pilot study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">August 29, 2019</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</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>Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare.</measure>
    <time_frame>baseline, on completion of session ( 5 weeks) and 6 month follow up</time_frame>
    <description>The patient activation measure (PAM) is a 100-point, quantifiable scale determining patient engagement in healthcare. PAM uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation involving four stages (see below). 0 indicates lower activation (worse) whereas 100 indicates higher activation (better)&#xD;
(1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-Efficacy to Perform Ostomy Self-Management Behaviors</measure>
    <time_frame>baseline, on completion of session ( 5 weeks) and 6 month follow up</time_frame>
    <description>Modified from Lorig and colleagues' Self-Efficacy to Perform Self-management Behaviors Scale, an outcome measure for Chronic Disease Management Interventions, this scale represents 8 domains with reported Cronbach's alpha for original scales: physical activity, information seeking,support, communication with HC providers, ostomy management , social and recreational, symptom management, and depression.&#xD;
Range 1 to 10, where higher is better outcome</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">216</enrollment>
  <condition>Colostomy Stoma</condition>
  <arm_group>
    <arm_group_label>Ostomy Self management Training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ostomy self-management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Usual care in peri-operative and long-term settings is not standardized for ostomy patients. Usual care does not provide any formal, reproducible training for patients or their caregivers. It typically consists of an Ostomy Care Nurse who works with patients and caregivers concerning technical issues (fitting, emptying, supplies, surrounding skin care, etc.) while the new ostomate is still an inpatient</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ostomy self management training</intervention_name>
    <description>Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations</description>
    <arm_group_label>Ostomy Self management Training</arm_group_label>
    <arm_group_label>Usual care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All cancer survivors over 21 years of age having undergone a procedure that needed an&#xD;
             intestinal stoma (fecal or urinary).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>110 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Krouse, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn Medicine</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/31720825/</url>
    <description>Cancer Survivors' Challenges With Ostomy Appliances and Self-Management: A Qualitative Analysis</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/29051047/</url>
    <description>Ostomy Telehealth for Cancer Survivors: Design of the Ostomy Self-management Training (OSMT) Randomized Trial</description>
  </link>
  <results_reference>
    <citation>Sun V, Ercolano E, McCorkle R, Grant M, Wendel CS, Tallman NJ, Passero F, Raza S, Cidav Z, Holcomb M, Weinstein RS, Hornbrook MC, Krouse RS. Ostomy telehealth for cancer survivors: Design of the Ostomy Self-management Training (OSMT) randomized trial. Contemp Clin Trials. 2018 Jan;64:167-172. doi: 10.1016/j.cct.2017.10.008. Epub 2017 Oct 16.</citation>
    <PMID>29051047</PMID>
  </results_reference>
  <results_reference>
    <citation>Sun V, Bojorquez O, Grant M, Wendel CS, Weinstein R, Krouse RS. Cancer survivors' challenges with ostomy appliances and self-management: a qualitative analysis. Support Care Cancer. 2020 Apr;28(4):1551-1554. doi: 10.1007/s00520-019-05156-7. Epub 2019 Nov 13.</citation>
    <PMID>31720825</PMID>
  </results_reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>November 4, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <results_first_submitted>June 1, 2020</results_first_submitted>
  <results_first_submitted_qc>July 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 11, 2020</results_first_posted>
  <last_update_submitted>August 11, 2020</last_update_submitted>
  <last_update_submitted_qc>August 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ileostomy</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Our Program Project team supports and promotes the sharing of resources as promoted by PCORI. Progress in medical research in general, and patient-reported outcome cancer research in particular, benefits from enhanced collaboration and sharing of data between productive, collaborative investigators. Based on this concept, our policy is to make the data collected as part of this proposal available to outside investigators based on the following guidelines.&#xD;
Our final research data will be shared with interested colleagues through peer-reviewed publications and presentations at scientific meetings.&#xD;
Any sharing of data with outside investigators must preserve the anonymity of the subjects per HIPAA guidelines.&#xD;
Collaboration with key personnel identified in the proposal is encouraged, but not strictly required.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>July 2021.</ipd_time_frame>
    <ipd_access_criteria>• All requests will be reviewed by the Principal Investigator and Co-Investigators named in this proposal who will apply the following principles when deciding whether the data should be shared:&#xD;
The request should be scientifically rigorous.&#xD;
If a collaboration with one or more project investigators is appropriate, such a collaboration should be established.&#xD;
The request should not conflict with ongoing or planned research by the PI or Co-Investigators.&#xD;
The request should not conflict with each institutional requirements. The investigators should agree to acknowledge the contribution in all presentations and publications.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT02974634/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>May 29, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT02974634/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were enrolled at three study sites through several mechanisms. These include identification of potential participants via institutional registry, records,databases.Referrals from site WOCNs, attending surgeons and other clinical providers; and through distribution of Institutional .&#xD;
Subjects were recruited from 11/01/16 to 10/01/2018.</recruitment_details>
      <pre_assignment_details>All cancer survivors over 21 years of age who were at least six weeks after a surgical procedure that necessitated the creation of an intestinal stoma (fecal or urinary) were recruited. Survivors with temporary ostomies were included, and there was no maximum time since surgery.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Ostomy Self Management Training</title>
          <description>The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones.&#xD;
Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations</description>
        </group>
        <group group_id="P2">
          <title>Usual Care</title>
          <description>Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="106"/>
                <participants group_id="P2" count="110"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="78"/>
                <participants group_id="P2" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="21"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Advanced disease</title>
              <participants_list>
                <participants group_id="P1" count="12"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Noncompliance</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="7"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>intervention technology related issues</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Study sites are three diverse geographic areas to ensure participation of diverse populations. Each of our participating institutions has a large catchment area which includes rural and inner-city populations. These are patient populations that are often under served as there is difficulty in participating in support groups or</population>
      <group_list>
        <group group_id="B1">
          <title>Ostomy Self Management Training</title>
          <description>Comparing OSMT group to UC group The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones.&#xD;
Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations</description>
        </group>
        <group group_id="B2">
          <title>Usual Care</title>
          <description>Comparing OSMT group to UC group&#xD;
Subjects were provided with physician and Wound ostomy nurses contacts and written information about an ostomy care. These study subject were expected only to complete study surveys.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="106"/>
            <count group_id="B2" value="110"/>
            <count group_id="B3" value="216"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.6" lower_limit="30" upper_limit="87"/>
                    <measurement group_id="B2" value="61.6" lower_limit="33" upper_limit="92"/>
                    <measurement group_id="B3" value="61.6" lower_limit="30" upper_limit="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="53"/>
                    <measurement group_id="B3" value="103"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="57"/>
                    <measurement group_id="B3" value="113"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="102"/>
                    <measurement group_id="B3" value="196"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="76"/>
                    <measurement group_id="B2" value="90"/>
                    <measurement group_id="B3" value="166"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <description>Research projects to be performed will include oversight of all aspects of the project including training and overseeing staff, participating in weekly conference calls, and coordinating data collection.The PIs will participate in data interpretation and dissemination of project findings.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="106"/>
                    <measurement group_id="B2" value="110"/>
                    <measurement group_id="B3" value="216"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare.</title>
        <description>The patient activation measure (PAM) is a 100-point, quantifiable scale determining patient engagement in healthcare. PAM uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation involving four stages (see below). 0 indicates lower activation (worse) whereas 100 indicates higher activation (better)&#xD;
(1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress.</description>
        <time_frame>baseline, on completion of session ( 5 weeks) and 6 month follow up</time_frame>
        <population>Intent to treat participants who provided baseline and at least one followup measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Ostomy Self Management Training</title>
            <description>The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones.&#xD;
Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare.</title>
          <description>The patient activation measure (PAM) is a 100-point, quantifiable scale determining patient engagement in healthcare. PAM uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation involving four stages (see below). 0 indicates lower activation (worse) whereas 100 indicates higher activation (better)&#xD;
(1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress.</description>
          <population>Intent to treat participants who provided baseline and at least one followup measurement</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="80"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="66.9" spread="12.9"/>
                    <measurement group_id="O2" value="64.2" spread="15.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post session</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="82"/>
                    <count group_id="O2" value="90"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="67.6" spread="12.9"/>
                    <measurement group_id="O2" value="66.2" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months follow up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="61"/>
                    <count group_id="O2" value="73"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70.7" spread="13.3"/>
                    <measurement group_id="O2" value="66.5" spread="12.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.06</p_value>
            <p_value_desc>Comparison of intervention and usual care at 6 month follow up</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Slope</param_type>
            <param_value>1.04</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>2.32</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-3.5</ci_lower_limit>
            <ci_upper_limit>5.6</ci_upper_limit>
            <estimate_desc>Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-Efficacy to Perform Ostomy Self-Management Behaviors</title>
        <description>Modified from Lorig and colleagues' Self-Efficacy to Perform Self-management Behaviors Scale, an outcome measure for Chronic Disease Management Interventions, this scale represents 8 domains with reported Cronbach's alpha for original scales: physical activity, information seeking,support, communication with HC providers, ostomy management , social and recreational, symptom management, and depression.&#xD;
Range 1 to 10, where higher is better outcome</description>
        <time_frame>baseline, on completion of session ( 5 weeks) and 6 month follow up</time_frame>
        <population>Intent to treat participants who provided baseline and at least one followup measurement</population>
        <group_list>
          <group group_id="O1">
            <title>Ostomy Self Management Training</title>
            <description>The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones. Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations</description>
          </group>
          <group group_id="O2">
            <title>Usual Care</title>
            <description>Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-Efficacy to Perform Ostomy Self-Management Behaviors</title>
          <description>Modified from Lorig and colleagues' Self-Efficacy to Perform Self-management Behaviors Scale, an outcome measure for Chronic Disease Management Interventions, this scale represents 8 domains with reported Cronbach's alpha for original scales: physical activity, information seeking,support, communication with HC providers, ostomy management , social and recreational, symptom management, and depression.&#xD;
Range 1 to 10, where higher is better outcome</description>
          <population>Intent to treat participants who provided baseline and at least one followup measurement</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="89"/>
                <count group_id="O2" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="86"/>
                    <count group_id="O2" value="99"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.7" spread="2.1"/>
                    <measurement group_id="O2" value="7.0" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post session</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="85"/>
                    <count group_id="O2" value="96"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.1" spread="2.0"/>
                    <measurement group_id="O2" value="7.3" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months follow up</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="66"/>
                    <count group_id="O2" value="79"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.3" spread="2.2"/>
                    <measurement group_id="O2" value="7.1" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.68</p_value>
            <p_value_desc>Comparison of intervention and usual care at 6 month follow up</p_value_desc>
            <method>t-test, 2 sided</method>
            <param_type>Slope</param_type>
            <param_value>0.34</param_value>
            <dispersion_type>Standard Error of the Mean</dispersion_type>
            <dispersion_value>0.29</dispersion_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>-0.24</ci_lower_limit>
            <ci_upper_limit>0.91</ci_upper_limit>
            <estimate_desc>Interaction coefficient (slope) of arm by time period (6 months follow up vs baseline) from mixed linear model</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected during the time subjects were part of the study from for 6 months.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Ostomy Self Management Training</title>
          <description>The intervention arm integrates goal setting and problem-solving approaches to enhance buy-in and encourage ability to carry out ostomy self-care. The curriculum was delivered via four group sessions by trained ostomy certified nurses and peer/experienced ostomates. An additional session was offered to support persons to address their needs related to ostomy care. Telehealth real-time videoconferencing was used to enhance program delivery to participants, usually in their homes, in three different geographic areas across two time zones. Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations</description>
        </group>
        <group group_id="E2">
          <title>Usual Care</title>
          <description>Patients in the usual care group receive regular ostomy care in a clinic or via email or phone, as well as a list of local and regional resources. These study subject were expected only to complete study surveys.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="110"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="106"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="110"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>Randomization methods led to equal numbers of males and females,but did not achieve balance.Several intervention subjects completed surveys without attending sessions. Few participants dropped out of the study due to a technology related concern.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Robert Krouse</name_or_title>
      <organization>University of Pennsylvania</organization>
      <phone>215-615-4573</phone>
      <email>robert.krouse@pennmedicine.upenn.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02974634
org study id: 826150
nct id: NCT02974634
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The purpose of this study is to test the benefits of an educational program, the Ostomy
      Self-Management Training (OSMT) program, for improving patient activation (preparedness to do
      self-care), self-efficacy (patients' ability to do self-care), knowledge of ostomy/urostomy
      self-care, quality of life, mood, use of medical services, and financial burden in patients
      with ostomies. The study will compare patients in the intervention (training) group and
      patients in the usual care group.

      Subjects' participation in this study is expected to last about 7 months. The PI plans to
      enroll up to 176 subjects at 3 hospitals (University of Pennsylvania, Yale University School
      of Nursing, and City of Hope in Los Angeles). All patient telehealth education will be
      coordinated by the University of Arizona in Tucson, Arizona.
Over one million individuals in the U.S. have ostomies. The American Cancer Society estimates
      39,610 rectal cancer cases and 74,000 bladder cancer cases will be diagnosed in 2015. Of
      these, at least 30,000 will receive ostomies, and an additional unknown number due to
      gynecologic, other gastrointestinal tumors. The HRQOL impact is tremendous and greater than
      with many other cancer treatments. An ostomy is often a prolonged or lifelong disabling
      problem for cancer survivors. The adaptation period is quite variable. 18% of participants
      took at least one year, or never felt comfortable, in their ostomy care. Importantly, many
      patients cannot attend selfmanagement programs or patient groups for a myriad of reasons,
      including distance to travel, monetary outlays, comorbidities making travel difficult, or
      lack of access to transportation. In addition, a national shortage of OCNs means patients
      with an ostomy, whether newly placed or a long-term issue, receive little help.

      It is imperative to study interventions for these cancer survivors aimed to limit family
      financial burdens, decrease medical care use, and improve well-being. This study has the
      potential to improve health care outcomes for cancer survivors with ostomies by enhancing
      their knowledge of and self-efficacy with ostomy care. This will be accomplished by improving
      the ability to communicate an established educational curriculum developed based on patient
      needs and desires and refined via a pilot study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Patient Activation Measure (PAM), a 100 Point Scale Determining Patient Engagement in Healthcare.
time frame: baseline, on completion of session ( 5 weeks) and 6 month follow up
description: The patient activation measure (PAM) is a 100-point, quantifiable scale determining patient engagement in healthcare. PAM uses a uni-dimensional, probabilistic Guttman-like scale that reflects a developmental model of activation involving four stages (see below). 0 indicates lower activation (worse) whereas 100 indicates higher activation (better)
(1) believing the patient role is important, (2) having the confidence and knowledge necessary to take action, (3) actually taking action to maintain and improve one's health, and (4) staying the course even under stress.
measure: Self-Efficacy to Perform Ostomy Self-Management Behaviors
time frame: baseline, on completion of session ( 5 weeks) and 6 month follow up
description: Modified from Lorig and colleagues' Self-Efficacy to Perform Self-management Behaviors Scale, an outcome measure for Chronic Disease Management Interventions, this scale represents 8 domains with reported Cronbach's alpha for original scales: physical activity, information seeking,support, communication with HC providers, ostomy management , social and recreational, symptom management, and depression.
Range 1 to 10, where higher is better outcome
arm group label: Ostomy Self management Training
arm group type: Active Comparator
description: Ostomy self-management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations
arm group label: Usual care
arm group type: Placebo Comparator
description: Usual care in peri-operative and long-term settings is not standardized for ostomy patients. Usual care does not provide any formal, reproducible training for patients or their caregivers. It typically consists of an Ostomy Care Nurse who works with patients and caregivers concerning technical issues (fitting, emptying, supplies, surrounding skin care, etc.) while the new ostomate is still an inpatient
intervention type: Other
intervention name: Ostomy self management training
description: Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations
arm group label: Ostomy Self management Training
arm group label: Usual care
criteria: 
gender: All
minimum age: 21 Years
maximum age: 110 Years
healthy volunteers: No
last name: Robert Krouse, MD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
url: https://pubmed.ncbi.nlm.nih.gov/31720825/
description: Cancer Survivors' Challenges With Ostomy Appliances and Self-Management: A Qualitative Analysis
url: https://pubmed.ncbi.nlm.nih.gov/29051047/
description: Ostomy Telehealth for Cancer Survivors: Design of the Ostomy Self-management Training (OSMT) Randomized Trial
citation: Sun V, Ercolano E, McCorkle R, Grant M, Wendel CS, Tallman NJ, Passero F, Raza S, Cidav Z, Holcomb M, Weinstein RS, Hornbrook MC, Krouse RS. Ostomy telehealth for cancer survivors: Design of the Ostomy Self-management Training (OSMT) randomized trial. Contemp Clin Trials. 2018 Jan;64:167-172. doi: 10.1016/j.cct.2017.10.008. Epub 2017 Oct 16.
PMID: 29051047
citation: Sun V, Bojorquez O, Grant M, Wendel CS, Weinstein R, Krouse RS. Cancer survivors' challenges with ostomy appliances and self-management: a qualitative analysis. Support Care Cancer. 2020 Apr;28(4):1551-1554. doi: 10.1007/s00520-019-05156-7. Epub 2019 Nov 13.
PMID: 31720825
responsible party type: Sponsor
sharing ipd: Yes
ipd description: Our Program Project team supports and promotes the sharing of resources as promoted by PCORI. Progress in medical research in general, and patient-reported outcome cancer research in particular, benefits from enhanced collaboration and sharing of data between productive, collaborative investigators. Based on this concept, our policy is to make the data collected as part of this proposal available to outside investigators based on the following guidelines.
Our final research data will be shared with interested colleagues through peer-reviewed publications and presentations at scientific meetings.
Any sharing of data with outside investigators must preserve the anonymity of the subjects per HIPAA guidelines.
Collaboration with key personnel identified in the proposal is encouraged, but not strictly required.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: July 2021.
ipd access criteria: • All requests will be reviewed by the Principal Investigator and Co-Investigators named in this proposal who will apply the following principles when deciding whether the data should be shared:
The request should be scientifically rigorous.
If a collaboration with one or more project investigators is appropriate, such a collaboration should be established.
The request should not conflict with ongoing or planned research by the PI or Co-Investigators.
The request should not conflict with each institutional requirements. The investigators should agree to acknowledge the contribution in all presentations and publications.
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Randomization methods led to equal numbers of males and females,but did not achieve balance.Several intervention subjects completed surveys without attending sessions. Few participants dropped out of the study due to a technology related concern.
point of contact: 