<clinical_study>
  <!-- This xml conforms to an XML Schema at:
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  <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/NCT02998086</url>
  </required_header>
  <id_info>
    <org_study_id>SC-N120</org_study_id>
    <nct_id>NCT02998086</nct_id>
  </id_info>
  <brief_title>PRISM for Parents of Children With Cancer Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer</brief_title>
  <official_title>A Pilot Randomized Controlled Trial of the Promoting Resilience in Stress Management (PRISM) Intervention for Parents of Children With Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seattle Children's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Parenting a child with cancer is highly stressful. The investigators have designed a&#xD;
      promising parent-centered intervention to bolster parent resilience and reduce stress and&#xD;
      distress. This study will test 2 formats of the intervention (individual or group-based) and&#xD;
      compare them to usual care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Parenting a child with cancer is highly distressing. Both during and after cancer therapy,&#xD;
      parents may suffer from poor mental health, risky health behaviors, and financial hardship,&#xD;
      all of which may impact patients, siblings, and the family unit. Positive psychological&#xD;
      resources can mitigate negative outcomes. In this regard, resilience is particularly&#xD;
      important, describing an individual's ability to maintain psychological and/or physical&#xD;
      well-being in the face of stress.&#xD;
&#xD;
      The investigators have previously described the &quot;Promoting Resilience in Stress Management&quot;&#xD;
      (PRISM) intervention for adolescent and young adult patients with cancer. This brief, 1:1&#xD;
      intervention targets four &quot;resilience resources&quot; over approximately 3 months: skills in&#xD;
      stress-management/mindfulness, goal-setting, cognitive restructuring, and meaning-making.&#xD;
      Notably, every parent whose child received the PRISM requested a similar intervention for&#xD;
      him- or herself. Hence, the investigators adapted two versions of the intervention for&#xD;
      parents (the &quot;PRISM-P&quot;). First, using the same 1:1 format, they piloted the PRISM-P amongst&#xD;
      12 parents of children with cancer. Feedback was highly positive; however, many parents&#xD;
      requested additional group-based social support. Second, they conducted a half-day symposium&#xD;
      and administered small-group adaptations of the PRISM-P to 70 parents of children with&#xD;
      serious illness. Feedback was again positive; however, the opportunity to develop individual&#xD;
      skills was limited.&#xD;
&#xD;
      This application proposes a pilot Randomized Clinical Trial (RCT) to evaluate and compare&#xD;
      these 2 formats of the PRISM-P with usual care, in order to determine optimal methodologies&#xD;
      and preferences for future, larger studies. Consecutive eligible parents of children with&#xD;
      newly diagnosed cancer will be randomly assigned to one of the 3 options (N=75 total, n=25&#xD;
      per arm). Secondary aims will assess parent-reported stress, burden of care, hope, goals,&#xD;
      optimism, benefit-finding, psychological distress, and health behaviors, and ongoing&#xD;
      perceptions of usefulness, feasibility, and preference.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2016</start_date>
  <completion_date type="Actual">December 2020</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</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>Parent-Reported Resilience</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parent-reported Stress Survey Response</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-reported psychological distress Survey Response</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-reported social support Survey Response</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-reported quality of life Survey Response</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parent-reported benefit finding Survey Response</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">107</enrollment>
  <condition>Pediatric Cancer</condition>
  <arm_group>
    <arm_group_label>Individual (1:1)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individual, 1:1 version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group-based version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual non-directed psychosocial supportive care</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Promoting Resilience in Stress Management</intervention_name>
    <description>Skills-based intervention designed to promote resilience resources</description>
    <arm_group_label>Group</arm_group_label>
    <arm_group_label>Individual (1:1)</arm_group_label>
    <other_name>PRISM</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: Parents of children who:&#xD;
&#xD;
          -  Are aged 2-24 years&#xD;
&#xD;
          -  Have been diagnosed with new malignancy between 1-10 weeks prior&#xD;
&#xD;
          -  Are scheduled to receive cancer-directed therapy at Seattle Children's Hospital&#xD;
&#xD;
          -  Has provided written informed consent (child aged 18 years and older), written assent&#xD;
             (child aged 13-17 years), verbal assent (child aged 7-12 years).&#xD;
&#xD;
          -  Able to speak and read English language&#xD;
&#xD;
          -  Cognitively able to participate in interactive interviews&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Parent is &lt; 18 years of age&#xD;
&#xD;
          -  Parent is cognitively or physically unable to participate in interactive interview&#xD;
&#xD;
          -  Parent is unable to speak and read English language&#xD;
&#xD;
          -  Parent or child participated on prior PRISM intervention study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Seattle Children's Hospital</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98145</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>March 15, 2021</last_update_submitted>
  <last_update_submitted_qc>March 15, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seattle Children's Hospital</investigator_affiliation>
    <investigator_full_name>Abby Rosenberg</investigator_full_name>
    <investigator_title>Associate Professor, Pediatrics, University of Washington</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02998086
org study id: SC-N120
nct id: NCT02998086
lead sponsor: 
has dmc: No
Parenting a child with cancer is highly stressful. The investigators have designed a
      promising parent-centered intervention to bolster parent resilience and reduce stress and
      distress. This study will test 2 formats of the intervention (individual or group-based) and
      compare them to usual care.
Parenting a child with cancer is highly distressing. Both during and after cancer therapy,
      parents may suffer from poor mental health, risky health behaviors, and financial hardship,
      all of which may impact patients, siblings, and the family unit. Positive psychological
      resources can mitigate negative outcomes. In this regard, resilience is particularly
      important, describing an individual's ability to maintain psychological and/or physical
      well-being in the face of stress.

      The investigators have previously described the "Promoting Resilience in Stress Management"
      (PRISM) intervention for adolescent and young adult patients with cancer. This brief, 1:1
      intervention targets four "resilience resources" over approximately 3 months: skills in
      stress-management/mindfulness, goal-setting, cognitive restructuring, and meaning-making.
      Notably, every parent whose child received the PRISM requested a similar intervention for
      him- or herself. Hence, the investigators adapted two versions of the intervention for
      parents (the "PRISM-P"). First, using the same 1:1 format, they piloted the PRISM-P amongst
      12 parents of children with cancer. Feedback was highly positive; however, many parents
      requested additional group-based social support. Second, they conducted a half-day symposium
      and administered small-group adaptations of the PRISM-P to 70 parents of children with
      serious illness. Feedback was again positive; however, the opportunity to develop individual
      skills was limited.

      This application proposes a pilot Randomized Clinical Trial (RCT) to evaluate and compare
      these 2 formats of the PRISM-P with usual care, in order to determine optimal methodologies
      and preferences for future, larger studies. Consecutive eligible parents of children with
      newly diagnosed cancer will be randomly assigned to one of the 3 options (N=75 total, n=25
      per arm). Secondary aims will assess parent-reported stress, burden of care, hope, goals,
      optimism, benefit-finding, psychological distress, and health behaviors, and ongoing
      perceptions of usefulness, feasibility, and preference.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Parent-Reported Resilience
time frame: 3 months
measure: Parent-reported Stress Survey Response
time frame: 3 months
measure: Parent-reported psychological distress Survey Response
time frame: 3 months
measure: Parent-reported social support Survey Response
time frame: 3 months
measure: Parent-reported quality of life Survey Response
time frame: 3 months
measure: Parent-reported benefit finding Survey Response
time frame: 3 months
arm group label: Individual (1:1)
arm group type: Experimental
description: Individual, 1:1 version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention
arm group label: Group
arm group type: Experimental
description: Group-based version of the Promoting Resilience in Stress Management for Parents (PRISM-P) intervention
arm group label: Usual Care
arm group type: No Intervention
description: Usual non-directed psychosocial supportive care
intervention type: Behavioral
intervention name: Promoting Resilience in Stress Management
description: Skills-based intervention designed to promote resilience resources
arm group label: Group
arm group label: Individual (1:1)
other name: PRISM
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Seattle Children's Hospital
investigator full name: Abby Rosenberg
investigator title: Associate Professor, Pediatrics, University of Washington
sharing ipd: Undecided