<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/NCT03229837</url>
  </required_header>
  <id_info>
    <org_study_id>PEPR II</org_study_id>
    <secondary_id>U19AR069525</secondary_id>
    <nct_id>NCT03229837</nct_id>
  </id_info>
  <brief_title>Validation Study of Pediatric Patient-Reported Outcomes</brief_title>
  <official_title>Pediatric Patient-Reported Outcomes (PEPR) for Childhood Cancer Survivors: Clinical Validity Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Jude Children's Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Philadelphia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Jude Children's Research Hospital</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>
      Survivors of childhood cancer often suffer treatment-related toxicities, including chronic&#xD;
      health conditions, high symptom burden and emotional distress, and decremented functional&#xD;
      status and quality of life. Although some patient-reported outcome (PRO) tools are available&#xD;
      for survivors of childhood cancer younger than 18 years old, very few studies have been&#xD;
      designed to evaluate longitudinal measurement properties of these PRO tools. In this study&#xD;
      the investigators propose to recruit participants from a cohort of diverse childhood cancer&#xD;
      survivors who were treated at St. Jude Children's Research Hospital (St. Jude) to improve&#xD;
      assessment tools for PROs and health-related quality of life (HRQOL).&#xD;
&#xD;
      The purpose of this study is to measure the link between Patient Reported Outcome Measurement&#xD;
      Information System (PROMIS) and clinical assessments of childhood cancer survivors over time.&#xD;
      PROMIS is a questionnaire that measures patient-reported outcomes in adults and children.&#xD;
&#xD;
      The study plans to enroll 300 children. Surveys will be completed by the children and their&#xD;
      parents/legal guardians (a total of 600 surveys).&#xD;
&#xD;
      PRIMARY OBJECTIVES:&#xD;
&#xD;
        1. To evaluate the longitudinal construct validity of the PROMIS Pediatric measures for&#xD;
           childhood cancer survivors by testing the association of change in PROMIS PRO scores and&#xD;
           the change in health status measured by objective clinical assessment. Age at baseline&#xD;
           and sex will be included in the analysis.&#xD;
&#xD;
        2. To establish clinically meaningful classifications of the PROMIS Pediatric measures for&#xD;
           childhood cancer survivors by referring PROMIS PRO scores to health status measured by&#xD;
           clinical assessment. Age at baseline and sex will be included in the analysis.&#xD;
&#xD;
        3. To estimate the minimally important differences (MIDs) of the PROMIS Pediatric measures&#xD;
           by referring to the change of health status evaluated by anchor-based anchors and&#xD;
           patient-based anchors for childhood cancer survivors. Age at baseline and sex will be&#xD;
           included in the analysis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A longitudinal framework was designed to collect data from childhood cancer survivors (8-18.9&#xD;
      years of age) and parents of participating cancer survivors (i.e., dyads) when they visit the&#xD;
      After Completion of Therapy (ACT) clinic at St. Jude in three consecutive years&#xD;
      (approximately 1 year apart; T1, T2, and T3).&#xD;
&#xD;
      Participants will complete pediatric patient-reported outcomes (PRO) survey/questionnaires, a&#xD;
      neurocognitive assessment and physical performance evaluation will be completed, and parental&#xD;
      surveys will be conducted. In addition, any data collected as part of the SJLIFE protocol may&#xD;
      also be used as part of this study.&#xD;
&#xD;
        1. The Pediatric PRO survey/questionnaires collection information on PROs. They include&#xD;
           questions about general health, pain interference, fatigue, psychological stress&#xD;
           experiences, stigma, sleep disturbance, sleep-related impairment, positive affect,&#xD;
           meaning and purpose, depressive symptoms, anxiety, and physical function-mobility. Each&#xD;
           cancer survivor will complete these during annual follow-up visits at three time points:&#xD;
           years 1, 2 and 3. This process takes approximately 30-40 minutes.&#xD;
&#xD;
        2. Neurocognitive evaluation is done by tests given by a licensed or certified&#xD;
           psychological examiner to evaluate how the participant processes information. The tests&#xD;
           evaluate how problems are solved, how well information is remembered, how well the&#xD;
           participant pays attention, how quickly they understand information, and their&#xD;
           assessment of quality of life. The tests are commonly used standardized tests that take&#xD;
           about 2 hours to complete.&#xD;
&#xD;
        3. Physical performance evaluation will measure heart and lung fitness, flexibility,&#xD;
           mobility, muscle strength, endurance, balance and physical mobility. Testing takes about&#xD;
           2 hours to complete and includes six-minute walk test, walking speed test, muscle&#xD;
           strength and flexibility, and balance.&#xD;
&#xD;
        4. The parental survey is a parent-report form (PRF) to be completed by parents/legal&#xD;
           guardians of participants. Information collected on the PRF includes demographic&#xD;
           information, parental quality of life, social support, family dynamics, parenting&#xD;
           behaviors, and the child's health care utilization data. The child and parent data will&#xD;
           be compared. Parental questionnaires will be completed at one time point, year 1, 2, or&#xD;
           3, and will take approximately 40 minutes to complete.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Actual">April 22, 2023</completion_date>
  <primary_completion_date type="Actual">April 22, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change of PROs</measure>
    <time_frame>From baseline through 3 years</time_frame>
    <description>The change of patient-reported outcome (PRO) between time points will be calculated.</description>
  </primary_outcome>
  <enrollment type="Actual">375</enrollment>
  <condition>Tumor</condition>
  <condition>Malignancy</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited from a cohort of diverse childhood cancer survivors who were&#xD;
        treatment at St. Jude and their parents/legal guardians.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for Childhood Survivors:&#xD;
&#xD;
          -  St. Jude childhood cancer survivors who have consented to SJLIFE;&#xD;
&#xD;
          -  Age at assessment: 8-18.9 years at T1 (toward 20.9 years at T3);&#xD;
&#xD;
          -  2 years off therapy and &gt; 5 years since diagnosis; and&#xD;
&#xD;
          -  Agrees to complete three annual assessments during routinely scheduled ACT clinic&#xD;
             appointments.&#xD;
&#xD;
        Exclusion Criteria for Childhood Survivors:&#xD;
&#xD;
          -  Cancer-related or unrelated (e.g., genetic disorders) neurocognitive injuries that&#xD;
             requires parents/proxies to complete the survey [e.g. intelligence quotient (IQ) &lt;70];&#xD;
&#xD;
          -  Inability to read and speak English; or&#xD;
&#xD;
          -  Parent doesn't agree to participate in the parent part of the study.&#xD;
&#xD;
        Inclusion Criteria for Parents/Legal Guardians:&#xD;
&#xD;
          -  Parent/legal guardian of St. Jude childhood cancer survivor aged 8-18.9 who is&#xD;
             eligible to participate and has agreed to do so;&#xD;
&#xD;
          -  Participant is not developmentally delayed, intellectually disabled or&#xD;
             non-communicative; and&#xD;
&#xD;
          -  Participant speaks and understands the English language.&#xD;
&#xD;
        Exclusion Criteria for Parents/Legal Guardians:&#xD;
&#xD;
          -  Developmentally delayed, intellectually disabled or non-communicative;&#xD;
&#xD;
          -  Unable to speak or understand the English language; and&#xD;
&#xD;
          -  Child doesn't agree to participate in child part of the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>I-Chan Huang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Jude Children's Research Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Jude Children's Research Hospital</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.stjude.org</url>
    <description>St. Jude Children's Research Hospital</description>
  </link>
  <link>
    <url>http://www.stjude.org/protocols</url>
    <description>Clinical Trials Open at St. Jude</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 7, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>August 9, 2023</last_update_submitted>
  <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Construct validity</keyword>
  <keyword>Minimally important differences</keyword>
  <keyword>Patient-reported outcomes</keyword>
  <keyword>Pediatric cancer survivors</keyword>
  <keyword>PROMIS pediatric measures</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>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/NCT03229837
org study id: PEPR II
secondary id: U19AR069525
nct id: NCT03229837
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Survivors of childhood cancer often suffer treatment-related toxicities, including chronic
      health conditions, high symptom burden and emotional distress, and decremented functional
      status and quality of life. Although some patient-reported outcome (PRO) tools are available
      for survivors of childhood cancer younger than 18 years old, very few studies have been
      designed to evaluate longitudinal measurement properties of these PRO tools. In this study
      the investigators propose to recruit participants from a cohort of diverse childhood cancer
      survivors who were treated at St. Jude Children's Research Hospital (St. Jude) to improve
      assessment tools for PROs and health-related quality of life (HRQOL).

      The purpose of this study is to measure the link between Patient Reported Outcome Measurement
      Information System (PROMIS) and clinical assessments of childhood cancer survivors over time.
      PROMIS is a questionnaire that measures patient-reported outcomes in adults and children.

      The study plans to enroll 300 children. Surveys will be completed by the children and their
      parents/legal guardians (a total of 600 surveys).

      PRIMARY OBJECTIVES:

        1. To evaluate the longitudinal construct validity of the PROMIS Pediatric measures for
           childhood cancer survivors by testing the association of change in PROMIS PRO scores and
           the change in health status measured by objective clinical assessment. Age at baseline
           and sex will be included in the analysis.

        2. To establish clinically meaningful classifications of the PROMIS Pediatric measures for
           childhood cancer survivors by referring PROMIS PRO scores to health status measured by
           clinical assessment. Age at baseline and sex will be included in the analysis.

        3. To estimate the minimally important differences (MIDs) of the PROMIS Pediatric measures
           by referring to the change of health status evaluated by anchor-based anchors and
           patient-based anchors for childhood cancer survivors. Age at baseline and sex will be
           included in the analysis.
A longitudinal framework was designed to collect data from childhood cancer survivors (8-18.9
      years of age) and parents of participating cancer survivors (i.e., dyads) when they visit the
      After Completion of Therapy (ACT) clinic at St. Jude in three consecutive years
      (approximately 1 year apart; T1, T2, and T3).

      Participants will complete pediatric patient-reported outcomes (PRO) survey/questionnaires, a
      neurocognitive assessment and physical performance evaluation will be completed, and parental
      surveys will be conducted. In addition, any data collected as part of the SJLIFE protocol may
      also be used as part of this study.

        1. The Pediatric PRO survey/questionnaires collection information on PROs. They include
           questions about general health, pain interference, fatigue, psychological stress
           experiences, stigma, sleep disturbance, sleep-related impairment, positive affect,
           meaning and purpose, depressive symptoms, anxiety, and physical function-mobility. Each
           cancer survivor will complete these during annual follow-up visits at three time points:
           years 1, 2 and 3. This process takes approximately 30-40 minutes.

        2. Neurocognitive evaluation is done by tests given by a licensed or certified
           psychological examiner to evaluate how the participant processes information. The tests
           evaluate how problems are solved, how well information is remembered, how well the
           participant pays attention, how quickly they understand information, and their
           assessment of quality of life. The tests are commonly used standardized tests that take
           about 2 hours to complete.

        3. Physical performance evaluation will measure heart and lung fitness, flexibility,
           mobility, muscle strength, endurance, balance and physical mobility. Testing takes about
           2 hours to complete and includes six-minute walk test, walking speed test, muscle
           strength and flexibility, and balance.

        4. The parental survey is a parent-report form (PRF) to be completed by parents/legal
           guardians of participants. Information collected on the PRF includes demographic
           information, parental quality of life, social support, family dynamics, parenting
           behaviors, and the child's health care utilization data. The child and parent data will
           be compared. Parental questionnaires will be completed at one time point, year 1, 2, or
           3, and will take approximately 40 minutes to complete.
observational model: Cohort
time perspective: Prospective
measure: Change of PROs
time frame: From baseline through 3 years
description: The change of patient-reported outcome (PRO) between time points will be calculated.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 18 Years
healthy volunteers: No
last name: I-Chan Huang, PhD
role: Principal Investigator
affiliation: St. Jude Children's Research Hospital
facility: 
country: United States
url: http://www.stjude.org
description: St. Jude Children's Research Hospital
url: http://www.stjude.org/protocols
description: Clinical Trials Open at St. Jude
responsible party type: Sponsor
mesh term: Neoplasms