xml: <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/NCT06038318</url>
    </required_header>
    <id_info>
      <org_study_id>22-652</org_study_id>
      <secondary_id>R01CA269574-01</secondary_id>
      <nct_id>NCT06038318</nct_id>
    </id_info>
    <brief_title>Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer</brief_title>
    <official_title>Promoting Resilience in Early Survivorship Among Adolescents and Young Adults With Cancer</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dana-Farber Cancer Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Cancer Institute (NCI)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Dana-Farber Cancer Institute</source>
    <oversight_info>
      <has_dmc>Yes</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>
        The goal of this study is to find the best way to help participants and families manage the&#xD;
        stress of facing a serious illness and be better able to &quot;bounce back&quot; or be resilient after&#xD;
        a difficult situation. Participants will take part in the &quot;Promoting Resilience in Stress&#xD;
        Management&quot; PRISM program, which is designed to provide skills to change or improve the&#xD;
        impact of stress in everyday life.&#xD;
  &#xD;
        The name of the intervention used in this research study is:&#xD;
  &#xD;
        -PRISM (a mobile app program comprised of 6 sessions of skills-based, manualized resilience&#xD;
        education)&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        In this sequential, multiple assignment, randomized trial participants will be randomly&#xD;
        selected to participate in PRISM program sessions with a trained research coach either by&#xD;
        text or by video sessions, or participants will use the PRISM mobile app program in a&#xD;
        self-guided way. Randomization means the group participants are placed in will be decided by&#xD;
        chance. All groups will continue to receive all the same care from primary medical, social&#xD;
        work, and other care teams.&#xD;
  &#xD;
        In this two-stage study, participants will be randomly assigned to either the &quot;app-only&quot; (20%&#xD;
        chance), &quot;text&quot; (40% chance) or &quot;video&quot; (40% chance) groups for the first stage. In the&#xD;
        second stage, participants may be re-randomized again to the &quot;app-only,&quot; or &quot;text,&quot; groups,&#xD;
        or will be referred to a specialty psychosocial support, social worker or counselor, based on&#xD;
        responses to questionnaires. Participants randomized to the &quot;app-only&quot; group in the first&#xD;
        stage will not be re-randomized.&#xD;
  &#xD;
        The research study procedures include screening for eligibility and completion of&#xD;
        questionnaires.&#xD;
  &#xD;
        Participation in this research study is expected to last for up to 6 months.&#xD;
  &#xD;
        It is expected about 325 people will take part in this research study.&#xD;
  &#xD;
        The National Institute for Health (NIH) is funding this research study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">March 2026</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Connor Davidson Resilience Scale (CDRISC-10) Score</measure>
      <time_frame>At 6 months</time_frame>
      <description>Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Evaluation will be based on the scores of the video and text cohorts vs. the self-guided cohort.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>CDRISC-10 Score for App-Only Cohort Responders</measure>
      <time_frame>3 months</time_frame>
      <description>Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Participant &quot;responders&quot; are defined as having sustained CDRISC scores &gt;29 after PRISM sessions or increased by &gt;2 points at the timepoints.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CDRISC-10 Score for Text Coach Cohort Responders</measure>
      <time_frame>3 months</time_frame>
      <description>Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Participant &quot;responders&quot; are defined as having sustained CDRISC scores &gt;29 after PRISM sessions or increased by &gt;2 points at the timepoints.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in HOPE Scale Score</measure>
      <time_frame>At Baseline, 3 months, and 6 months</time_frame>
      <description>Assessed by the HOPE Scale, a 12-item measures scored on an 8-point Likert scale with answers ranging from 1 &quot;Definitely False&quot; to 8 &quot;Definitely True&quot; for a total score of 96. A higher score implies a greater level of hopeful thought patterns.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Adolescent Participant Quality of Life Total Score</measure>
      <time_frame>At Baseline, 3 months, and 6 months</time_frame>
      <description>Assessed by the Pediatric Quality of Life (PedsQL) Generic Core Scales Short Form (SF15) (Teen or Child Report) and PedsQL Cancer Module (Child or Teen Report) scales, 42-items to evaluate health-related quality of life. Items are rated on a 5-point Likert scale with answers ranging from 0 &quot;Never&quot; to 4 &quot;Almost Always&quot; for a score range of 0 - 100. A higher score represents better health-related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Young Adult Participant Quality of Life Total Score</measure>
      <time_frame>At Baseline, 3 months, and 6 months</time_frame>
      <description>Assessed by the Pediatric Quality of Life (PedsQL) Generic Core Scales Short Form (SF15) Young Adult Report and PedsQL Cancer Module Young Adult Report scales, 42-items to evaluate health-related quality of life. Items are rated on a 5-point Likert scale with answers ranging from 0 &quot;Never&quot; to 4 &quot;Almost Always&quot; for a score range of 0 - 100. A higher score represents better health-related quality of life.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Kessler-6 Psychological Distress Scale Score</measure>
      <time_frame>At Baseline, 3 months, and 6 months</time_frame>
      <description>Assessed by the Kessler-6, a 6-item measure for the level of psychological distress in the past month. Responses are scored on a 5-point Likert scare with answers ranging from 0 &quot;None of the time&quot; to 4 &quot;All of the time,&quot; and with a total score range of 0 - 4. Scores &gt; or = 7 suggest &quot;high&quot; distressed and those &gt; or = 13 meet criteria for serious or debilitating psychological distress.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score</measure>
      <time_frame>At Baseline, 3 months, and 6 months</time_frame>
      <description>Assessed by the HADS-A subscale which is comprised of 7 items. Items are scored 0-3 with a subscale total score range of 0 - 21. A higher scores represents increasing abnormality (or caseness) for anxiety.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in HADS Depression Subscale Score</measure>
      <time_frame>At Baseline, 3 months, and 6 months</time_frame>
      <description>Assessed by the HADS-D subscale score which is comprised of 7 items. Items are scored 0-3 with a subscale total score range of 0 - 21. A higher score represents increasing abnormality (or caseness) for depression.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">325</enrollment>
    <condition>Stress</condition>
    <condition>Anxiety</condition>
    <arm_group>
      <arm_group_label>PRISM Program Mobile App</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be randomized to &quot;app-only&quot; group and will complete:&#xD;
  Baseline questionnaire.&#xD;
  mPRISM App self guided modules&#xD;
  3 month questionnaire.&#xD;
  mPRISM App self guided modules until final survey at 6 months and end of participation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PRISM Program Video Coach</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will be randomized to &quot;video&quot; group and will complete:&#xD;
  Baseline questionnaire.&#xD;
  PRISM sessions.&#xD;
  3 month questionnaire with re-randomization to either &quot;app-only&quot; or &quot;text&quot; groups or referral to specialty psychosocial support.&#xD;
  After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>PRISM Program Text Coach</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Participants will be randomized to &quot;text&quot; group and will complete:&#xD;
  Baseline questionnaire.&#xD;
  PRISM sessions.&#xD;
  3 month questionnaire with re-randomization to &quot;app-only,&quot; &quot;text,&quot; or &quot;video&quot; groups.&#xD;
  After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>PRISM Program Video Coach</intervention_name>
      <description>A 6-session, skills-based, manualized resilience education program delivered via video coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by a HIPAA compliant videoconferencing platform, Zoom, approximately every 1-2 weeks based on participant preference. For participants who do not have smartphones, temporary equipment will be provided.</description>
      <arm_group_label>PRISM Program Video Coach</arm_group_label>
      <other_name>Promoting Resilience in Stress Management</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>PRISM Program Text Coach</intervention_name>
      <description>A 6-session, skills-based, manualized, resilience education program delivered via text coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by HIPAA compliant SMS text-messaging service, Zoom, approximately every other week. For participants who do not have smartphones, temporary equipment will be provided.</description>
      <arm_group_label>PRISM Program Text Coach</arm_group_label>
      <other_name>Promoting Resilience in Stress Management</other_name>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>mPRISM Program App</intervention_name>
      <description>6 static modules to practice skills-based, manualized, resilience education program delivered via PRISM Program mobile app. For participants who do not have smartphones, temporary equipment will be provided.</description>
      <arm_group_label>PRISM Program Mobile App</arm_group_label>
      <arm_group_label>PRISM Program Text Coach</arm_group_label>
      <arm_group_label>PRISM Program Video Coach</arm_group_label>
      <other_name>Promoting Resilience in Stress Management</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Participants that have completed their main cancer-directed therapy at one of the study&#xD;
          sites affiliated centers who meet all the eligibility criteria will be eligible for&#xD;
          participation in this study.&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  All genders ≥ 12 and ≤ 25 years of age at baseline&#xD;
  &#xD;
            -  Participant is able to speak English or Spanish language (for PRISM sessions)&#xD;
  &#xD;
            -  Participant is able to read English or Spanish language (for completion of surveys)&#xD;
  &#xD;
            -  Participant is cognitively able to participate in PRISM sessions and complete written&#xD;
               questionnaires and surveys, as judged by the site investigator&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>25 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Abby Rosenberg, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dana-Farber Cancer Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Abby Rosenberg, MD</last_name>
      <phone>206-987-6892</phone>
      <email>AbbyR_Rosenberg@DFCI.HARVARD.EDU</email>
    </overall_contact>
    <location>
      <facility>
        <name>Boston Children's Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Abby Rosenberg, MD</last_name>
        <phone>206-987-6892</phone>
        <email>abbyr_rosenberg@dfci.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>Abby Rosenberg, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Dana-Farber Cancer Institute</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Abby Rosenberg, MD</last_name>
        <phone>206-987-6892</phone>
        <email>abbyr_rosenberg@dfci.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>Abby Rosenberg, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Dana-Farber Cancer Institute</investigator_affiliation>
      <investigator_full_name>Abby Rosenberg</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Stress Management</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>Data can be shared no earlier than 1 year following the date of publication</ipd_time_frame>
      <ipd_access_criteria>Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06038318
  org study id: 22-652
  secondary id: R01CA269574-01
  nct id: NCT06038318
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this study is to find the best way to help participants and families manage the
        stress of facing a serious illness and be better able to "bounce back" or be resilient after
        a difficult situation. Participants will take part in the "Promoting Resilience in Stress
        Management" PRISM program, which is designed to provide skills to change or improve the
        impact of stress in everyday life.
  
        The name of the intervention used in this research study is:
  
        -PRISM (a mobile app program comprised of 6 sessions of skills-based, manualized resilience
        education)
  In this sequential, multiple assignment, randomized trial participants will be randomly
        selected to participate in PRISM program sessions with a trained research coach either by
        text or by video sessions, or participants will use the PRISM mobile app program in a
        self-guided way. Randomization means the group participants are placed in will be decided by
        chance. All groups will continue to receive all the same care from primary medical, social
        work, and other care teams.
  
        In this two-stage study, participants will be randomly assigned to either the "app-only" (20%
        chance), "text" (40% chance) or "video" (40% chance) groups for the first stage. In the
        second stage, participants may be re-randomized again to the "app-only," or "text," groups,
        or will be referred to a specialty psychosocial support, social worker or counselor, based on
        responses to questionnaires. Participants randomized to the "app-only" group in the first
        stage will not be re-randomized.
  
        The research study procedures include screening for eligibility and completion of
        questionnaires.
  
        Participation in this research study is expected to last for up to 6 months.
  
        It is expected about 325 people will take part in this research study.
  
        The National Institute for Health (NIH) is funding this research study.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Health Services Research
  masking: None (Open Label)
  measure: Connor Davidson Resilience Scale (CDRISC-10) Score
  time frame: At 6 months
  description: Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Evaluation will be based on the scores of the video and text cohorts vs. the self-guided cohort.
  measure: CDRISC-10 Score for App-Only Cohort Responders
  time frame: 3 months
  description: Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Participant "responders" are defined as having sustained CDRISC scores >29 after PRISM sessions or increased by >2 points at the timepoints.
  measure: CDRISC-10 Score for Text Coach Cohort Responders
  time frame: 3 months
  description: Assessed by the CDRISC-10, a 10-item measures consisting of a 5-point Likert scale with answers ranging from 0 (not true at all) to 4 (true nearly all the time) for a total of 40 points. Higher scores reflect greater resilience. Participant "responders" are defined as having sustained CDRISC scores >29 after PRISM sessions or increased by >2 points at the timepoints.
  measure: Change in HOPE Scale Score
  time frame: At Baseline, 3 months, and 6 months
  description: Assessed by the HOPE Scale, a 12-item measures scored on an 8-point Likert scale with answers ranging from 1 "Definitely False" to 8 "Definitely True" for a total score of 96. A higher score implies a greater level of hopeful thought patterns.
  measure: Change in Adolescent Participant Quality of Life Total Score
  time frame: At Baseline, 3 months, and 6 months
  description: Assessed by the Pediatric Quality of Life (PedsQL) Generic Core Scales Short Form (SF15) (Teen or Child Report) and PedsQL Cancer Module (Child or Teen Report) scales, 42-items to evaluate health-related quality of life. Items are rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Almost Always" for a score range of 0 - 100. A higher score represents better health-related quality of life.
  measure: Change in Young Adult Participant Quality of Life Total Score
  time frame: At Baseline, 3 months, and 6 months
  description: Assessed by the Pediatric Quality of Life (PedsQL) Generic Core Scales Short Form (SF15) Young Adult Report and PedsQL Cancer Module Young Adult Report scales, 42-items to evaluate health-related quality of life. Items are rated on a 5-point Likert scale with answers ranging from 0 "Never" to 4 "Almost Always" for a score range of 0 - 100. A higher score represents better health-related quality of life.
  measure: Change in Kessler-6 Psychological Distress Scale Score
  time frame: At Baseline, 3 months, and 6 months
  description: Assessed by the Kessler-6, a 6-item measure for the level of psychological distress in the past month. Responses are scored on a 5-point Likert scare with answers ranging from 0 "None of the time" to 4 "All of the time," and with a total score range of 0 - 4. Scores > or = 7 suggest "high" distressed and those > or = 13 meet criteria for serious or debilitating psychological distress.
  measure: Change in Hospital Anxiety and Depression Scale (HADS) Anxiety Subscale Score
  time frame: At Baseline, 3 months, and 6 months
  description: Assessed by the HADS-A subscale which is comprised of 7 items. Items are scored 0-3 with a subscale total score range of 0 - 21. A higher scores represents increasing abnormality (or caseness) for anxiety.
  measure: Change in HADS Depression Subscale Score
  time frame: At Baseline, 3 months, and 6 months
  description: Assessed by the HADS-D subscale score which is comprised of 7 items. Items are scored 0-3 with a subscale total score range of 0 - 21. A higher score represents increasing abnormality (or caseness) for depression.
  arm group label: PRISM Program Mobile App
  arm group type: Experimental
  description: Participants will be randomized to "app-only" group and will complete:
  Baseline questionnaire.
  mPRISM App self guided modules
  3 month questionnaire.
  mPRISM App self guided modules until final survey at 6 months and end of participation.
  arm group label: PRISM Program Video Coach
  arm group type: Active Comparator
  description: Participants will be randomized to "video" group and will complete:
  Baseline questionnaire.
  PRISM sessions.
  3 month questionnaire with re-randomization to either "app-only" or "text" groups or referral to specialty psychosocial support.
  After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation.
  arm group label: PRISM Program Text Coach
  arm group type: Active Comparator
  description: Participants will be randomized to "text" group and will complete:
  Baseline questionnaire.
  PRISM sessions.
  3 month questionnaire with re-randomization to "app-only," "text," or "video" groups.
  After re-randomization, participants will complete PRISM sessions until final survey at 6 months and end of participation.
  intervention type: Behavioral
  intervention name: PRISM Program Video Coach
  description: A 6-session, skills-based, manualized resilience education program delivered via video coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by a HIPAA compliant videoconferencing platform, Zoom, approximately every 1-2 weeks based on participant preference. For participants who do not have smartphones, temporary equipment will be provided.
  arm group label: PRISM Program Video Coach
  other name: Promoting Resilience in Stress Management
  intervention type: Behavioral
  intervention name: PRISM Program Text Coach
  description: A 6-session, skills-based, manualized, resilience education program delivered via text coaching by trained English or Spanish speaking PRISM coaches. Participants will have complete access to the PRISM Program mobile app. Sessions will be delivered by HIPAA compliant SMS text-messaging service, Zoom, approximately every other week. For participants who do not have smartphones, temporary equipment will be provided.
  arm group label: PRISM Program Text Coach
  other name: Promoting Resilience in Stress Management
  intervention type: Behavioral
  intervention name: mPRISM Program App
  description: 6 static modules to practice skills-based, manualized, resilience education program delivered via PRISM Program mobile app. For participants who do not have smartphones, temporary equipment will be provided.
  arm group label: PRISM Program Mobile App
  arm group label: PRISM Program Text Coach
  arm group label: PRISM Program Video Coach
  other name: Promoting Resilience in Stress Management
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 25 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Abby Rosenberg, MD
  role: Principal Investigator
  affiliation: Dana-Farber Cancer Institute
  last name: Abby Rosenberg, MD
  phone: 206-987-6892
  email: AbbyR_Rosenberg@DFCI.HARVARD.EDU
  facility: 
  contact: 
  investigator: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Dana-Farber Cancer Institute
  investigator full name: Abby Rosenberg
  investigator title: Principal Investigator
  sharing ipd: Yes
  ipd description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: Data can be shared no earlier than 1 year following the date of publication
  ipd access criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu