<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/NCT04492007</url>
  </required_header>
  <id_info>
    <org_study_id>LCCC1929</org_study_id>
    <nct_id>NCT04492007</nct_id>
  </id_info>
  <brief_title>Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)</brief_title>
  <acronym>PRISMS</acronym>
  <official_title>Feasibility Testing of Patient Reported Outcomes - Informed Symptom Management System (PRISMS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UNC Lineberger Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UNC Lineberger Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the&#xD;
      innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance&#xD;
      personalized supportive care for cancer patients and caregivers during post-treatment care&#xD;
      transition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this proof-of-concept study, our multidisciplinary team will conduct a pilot randomized&#xD;
      clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed&#xD;
      Symptom Management System (PRISMS) to enhance personalized supportive care for cancer&#xD;
      patients and caregivers during post-treatment care transition. We will randomly assign 21&#xD;
      cancer patients with newly created ostomies for cancer treatment with curative intent and&#xD;
      their primary caregivers to the PRISMS or usual care groups (21 patient-caregiver dyads, a&#xD;
      total of 42 individuals). PRISMS is defined as a personalized psychoeducational website&#xD;
      including monitoring and personal feedback. We will conduct pre- and post-assessments of QOL&#xD;
      and PRO (symptoms) at baseline upon enrollment and 2 months later.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2020</start_date>
  <completion_date type="Actual">December 20, 2021</completion_date>
  <primary_completion_date type="Actual">October 21, 2021</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>Supportive Care</primary_purpose>
    <masking>Triple (Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>from study launching to completion</time_frame>
    <description>Recruitment rate will be assessed by the percentage of potentially eligible participants who have consented to participate in the study</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Enrollment rate</measure>
    <time_frame>after T1 (baseline survey)</time_frame>
    <description>Enrollment rate will be assessed by the percentage of potentially eligible participants who have completed the baseline survey.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Retention rate</measure>
    <time_frame>after T2 (2-month followup survey)</time_frame>
    <description>Retention rate will be assessed by the percentage of enrolled participants who have completed the 2-month followup survey at the end of the study period.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Satisfaction with the PRISMS program</measure>
    <time_frame>after T2 (2-month followup survey)</time_frame>
    <description>Satisfaction with the PRISMS program will be assessed by the 9-item Participant Satisfaction Scale measuring the level of program satisfaction ranging from 1=not satisfied to 5=extremely satisfied. Higher total score indicates greater program satisfaction.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perceived ease of use of the PRISMS program</measure>
    <time_frame>after T2 (2-month followup survey)</time_frame>
    <description>Perceived ease of use of the PRISMS program will be assessed by the 23-item Usability Scale measuring the ease of use in three aspects: general, content, and navigation. The scales range from 1=strongly disagree to 5=strongly agree. Higher total score indicates greater ease of use.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of Quality of Life (QOL)</measure>
    <time_frame>T1 (baseline survey) and T2 (2-month followup survey)</time_frame>
    <description>Quality of Life (QoL) will be assessed using the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change. FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life. Change in the FACT-G scores from T1 (baseline survey) to T2 (2-month followup survey) will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Healthcare Utilization Extracted From Electronic Medical Record</measure>
    <time_frame>90 days past T1 (baseline survey)</time_frame>
    <description>The total number of ostomy-related followup visits, emergency room use and re-admissions.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">46</enrollment>
  <condition>Colorectal Cancer</condition>
  <condition>Bladder Cancer</condition>
  <condition>Ovarian Cancer</condition>
  <condition>Cervical Cancer</condition>
  <condition>Uterine Cancer</condition>
  <arm_group>
    <arm_group_label>PRISMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In addition to usual care, participants assigned to this arm will have access to our Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) program.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants assigned to this arm will receive the standard of care that is provided to all patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)</intervention_name>
    <description>Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications (e.g., skin infection, fatigue) from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through videoconferencing/telephone from the research nurse and also their healthcare providers at the hospital(s) if they experience moderate to severe symptoms and/or abnormal sign (e.g., body temperature is greater than 98.6 C</description>
    <arm_group_label>PRISMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients must:&#xD;
&#xD;
          -  have been surgically treated for colorectal, bladder, ovarian, cervical, or uterine&#xD;
             cancer with curative intent;&#xD;
&#xD;
          -  be within one month of hospital discharge of a newly created ostomy with curative&#xD;
             intent;&#xD;
&#xD;
          -  be able to read and speak English;&#xD;
&#xD;
          -  be 18 years or older;&#xD;
&#xD;
          -  have a caregiver who is willing to participate in the study;&#xD;
&#xD;
        Caregivers must:&#xD;
&#xD;
          -  be 18 years or older;&#xD;
&#xD;
          -  be able to read and speak English;&#xD;
&#xD;
          -  be identified as the primary caregiver by the patient;&#xD;
&#xD;
          -  have not themselves been diagnosed with cancer or received cancer treatment during the&#xD;
             study (to ensure that patients and caregivers focus their efforts on care of the&#xD;
             patient).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients and their caregivers will be excluded if they:&#xD;
&#xD;
          -  are unable to read, speak, or understand English;&#xD;
&#xD;
          -  have more than one type of ostomy;&#xD;
&#xD;
          -  have other cancer diagnosis (excluding non-melanomatous skin cancer); or&#xD;
&#xD;
          -  have cognitive impairment (assessed by the Short Portable Mental Status&#xD;
             Questionnaire).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lixin Song, RN, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of North Carolina at Chapel Hill</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>August 29, 2022</last_update_submitted>
  <last_update_submitted_qc>August 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ostomy (colostomy, urostomy, and ileostomy)</keyword>
  <keyword>symptom</keyword>
  <keyword>self-management</keyword>
  <keyword>caregiving</keyword>
  <keyword>family research</keyword>
  <keyword>telehealth</keyword>
  <keyword>self-efficacy</keyword>
  <keyword>quality of life</keyword>
  <keyword>post-treatment care transition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>This is a pilot study with very small sample size and specific inclusion criteria. Sharing data with others may increase the risk to patient confidentiality.</ipd_description>
  </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/NCT04492007
org study id: LCCC1929
nct id: NCT04492007
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a proof-of-concept pilot randomized clinical trial to test the feasibility of the
      innovative Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) to enhance
      personalized supportive care for cancer patients and caregivers during post-treatment care
      transition.
In this proof-of-concept study, our multidisciplinary team will conduct a pilot randomized
      clinical trial to test the feasibility of the innovative Patient-Reported Outcomes-Informed
      Symptom Management System (PRISMS) to enhance personalized supportive care for cancer
      patients and caregivers during post-treatment care transition. We will randomly assign 21
      cancer patients with newly created ostomies for cancer treatment with curative intent and
      their primary caregivers to the PRISMS or usual care groups (21 patient-caregiver dyads, a
      total of 42 individuals). PRISMS is defined as a personalized psychoeducational website
      including monitoring and personal feedback. We will conduct pre- and post-assessments of QOL
      and PRO (symptoms) at baseline upon enrollment and 2 months later.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Triple (Care Provider, Investigator, Outcomes Assessor)
measure: Recruitment rate
time frame: from study launching to completion
description: Recruitment rate will be assessed by the percentage of potentially eligible participants who have consented to participate in the study
measure: Enrollment rate
time frame: after T1 (baseline survey)
description: Enrollment rate will be assessed by the percentage of potentially eligible participants who have completed the baseline survey.
measure: Retention rate
time frame: after T2 (2-month followup survey)
description: Retention rate will be assessed by the percentage of enrolled participants who have completed the 2-month followup survey at the end of the study period.
measure: Satisfaction with the PRISMS program
time frame: after T2 (2-month followup survey)
description: Satisfaction with the PRISMS program will be assessed by the 9-item Participant Satisfaction Scale measuring the level of program satisfaction ranging from 1=not satisfied to 5=extremely satisfied. Higher total score indicates greater program satisfaction.
measure: Perceived ease of use of the PRISMS program
time frame: after T2 (2-month followup survey)
description: Perceived ease of use of the PRISMS program will be assessed by the 23-item Usability Scale measuring the ease of use in three aspects: general, content, and navigation. The scales range from 1=strongly disagree to 5=strongly agree. Higher total score indicates greater ease of use.
measure: Change of Quality of Life (QOL)
time frame: T1 (baseline survey) and T2 (2-month followup survey)
description: Quality of Life (QoL) will be assessed using the Functional Assessment of Cancer Therapy General Scale (FACT-G) v.4, a 27-item measure yielding total score and scores for physical, social/family, emotional, and functional well-being of demonstrated reliability, validity, and sensitivity to change. FACT-G consists of 4 subscales: physical well-being (PWB), functional well-being (FWB), emotional well-being (EWB) and social well-being (SWB). Scores on the four subscales are summed to produce a total score ranging from 0 to 108 with higher scores indicating better quality of life. Change in the FACT-G scores from T1 (baseline survey) to T2 (2-month followup survey) will be calculated.
measure: Healthcare Utilization Extracted From Electronic Medical Record
time frame: 90 days past T1 (baseline survey)
description: The total number of ostomy-related followup visits, emergency room use and re-admissions.
arm group label: PRISMS
arm group type: Experimental
description: In addition to usual care, participants assigned to this arm will have access to our Patient-Reported Outcomes-Informed Symptom Management System (PRISMS) program.
arm group label: Usual Care
arm group type: No Intervention
description: Participants assigned to this arm will receive the standard of care that is provided to all patients.
intervention type: Behavioral
intervention name: Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)
description: Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications (e.g., skin infection, fatigue) from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through videoconferencing/telephone from the research nurse and also their healthcare providers at the hospital(s) if they experience moderate to severe symptoms and/or abnormal sign (e.g., body temperature is greater than 98.6 C
arm group label: PRISMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
last name: Lixin Song, RN, PhD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Uterine Neoplasms
sharing ipd: No
ipd description: This is a pilot study with very small sample size and specific inclusion criteria. Sharing data with others may increase the risk to patient confidentiality.