<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/NCT03768336</url>
  </required_header>
  <id_info>
    <org_study_id>18-428</org_study_id>
    <secondary_id>1K07CA211955-01A1</secondary_id>
    <nct_id>NCT03768336</nct_id>
  </id_info>
  <brief_title>A Stress Management and Resiliency Program for Adolescent and Young Adult Survivors</brief_title>
  <official_title>A Stress Management and Resiliency Program for Adolescent and Young Adult Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General 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>
      This research study aims to explore the feasibility and acceptability of an adapted&#xD;
      resiliency group program, called the Relaxation Response Resiliency Program (3RP-AYA), to&#xD;
      reduce stress and promote stress-management among adolescents and young adults who have&#xD;
      completed treatment for cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Relaxation Response Resiliency Program, or 3RP, was developed by researchers at the MGH&#xD;
      Benson-Henry Institute for Mind Body Medicine. The 3RP is a group program that-through a&#xD;
      variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress&#xD;
      and promote psychological resiliency and physical well-being.&#xD;
&#xD;
      The 3RP has not yet been carried out with adolescent or young adult individuals who have&#xD;
      recently completed treatment for cancer. As such, the investigators have adapted the original&#xD;
      3RP to target the specific needs of adolescent and young adult patients who are transitioning&#xD;
      off active treatment. The investigators are conducting this study to see if the adapted&#xD;
      program, the 3RP-AYA, is effective at reducing stress and stress-related symptoms for people&#xD;
      of at least age 16 who have completed treatment for cancer within the past five years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Anticipated">July 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2023</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll</measure>
    <time_frame>Post-treatment completion (treatment is approximately 8 weeks)</time_frame>
    <description>Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline). Qualitative information from experts and participants will be used to inform feasibility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program</measure>
    <time_frame>Post-treatment completion (treatment is approximately 8 weeks)</time_frame>
    <description>Among those who initiated the program, this is the proportion of patients who completed the program (defined as completing 6 out of 8 sessions). Qualitative information from experts and participants will be used to inform feasibility.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>3RP-AYA Acceptability: Five Questions</measure>
    <time_frame>Post-treatment completion (treatment is approximately 8 weeks)</time_frame>
    <description>Acceptability will be assessed with five questions rated on a 4-point Likert scale (1=not at all to 4=very). Items will prompt participants to rate the extent to which they found the program to be enjoyable, helpful, applicable, convenient, and satisfaction. Qualitative information from experts and patients will also inform acceptability.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Waitlist Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions&#xD;
Mini relaxation practice&#xD;
Weekly goal check-ins&#xD;
RR-practice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>3RP Group Sessions</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions&#xD;
Mini relaxation practice&#xD;
Weekly goal check-ins&#xD;
RR-practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Waitlist control</intervention_name>
    <description>The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being. Waitlist control receives the adapted 3RP program (3RP-AYA) approximately 2 months after study enrollment.</description>
    <arm_group_label>Waitlist Control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3RP-AYA</intervention_name>
    <description>The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being.</description>
    <arm_group_label>3RP Group Sessions</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with any cancer between ages 14 and 29&#xD;
&#xD;
          -  Completed cancer treatment within the past 5 years&#xD;
&#xD;
          -  At least 16 years of age at time of enrollment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unwilling or unable to participate in the study&#xD;
&#xD;
          -  Unable to speak or read English&#xD;
&#xD;
          -  Is medically or otherwise unable to participate (as determined by a physician or study&#xD;
             PI)&#xD;
&#xD;
          -  Unwilling or unable to participate in study sessions delivered via the Partners&#xD;
             Telehealth videoconferencing software&#xD;
&#xD;
          -  Participation in a focus group during Phase 1 (DF/HCC 17-315)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Giselle K. Perez, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <results_first_submitted>September 10, 2022</results_first_submitted>
  <results_first_submitted_qc>December 7, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 28, 2022</results_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Giselle K. Perez Lougee</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Behavioral Intervention</keyword>
  <keyword>Adolescent</keyword>
  <keyword>Young Adult</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>July 7, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/36/NCT03768336/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>As per our approved protocol, only individuals who signed consent and completed the baseline assessment were considered to be enrolled. Hence, 72 people met this criteria.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>3RP Group Sessions</title>
          <description>The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions immediately after enrollment.</description>
        </group>
        <group group_id="P2">
          <title>Waitlist Control</title>
          <description>The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions 2-months after enrollment.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Baseline Completion</title>
              <participants_list>
                <participants group_id="P1" count="35"/>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Remained Eligible</title>
              <participants_list>
                <participants group_id="P1" count="33">n=2 people who were randomized to the intervention had cancer recurrences, causing them to become ineligible.</participants>
                <participants group_id="P2" count="37"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Program Initiation</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Follow up Survey #1</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="35"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Follow up Survey #2</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="29"/>
                <participants group_id="P2" count="34"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Became Ineligible</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed final survey (3-month follow-up)</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Missed final survey (post-treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>This is a conservative number that consists of all patients who were officially enrolled in the trial (regardless of whether or not they began the intervention), defined as having consented and completed the baseline survey.</population>
      <group_list>
        <group group_id="B1">
          <title>Enrolled Patients</title>
          <description>All participants who consented and completed the baseline survey</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="72"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.76" spread="3.26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Gender</title>
              <category_list>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Prefer not to describe</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/ethnicity</title>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Mixed Race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Months since treatment completion</title>
          <units>months</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18.82" spread="16.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll</title>
        <description>Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline). Qualitative information from experts and participants will be used to inform feasibility.</description>
        <time_frame>Post-treatment completion (treatment is approximately 8 weeks)</time_frame>
        <population>This consists of the total number of individuals who were eligible, were approached and informed about the study, and were offered the opportunity to participate.</population>
        <group_list>
          <group group_id="O1">
            <title>Total Individuals Approached</title>
            <description>This consists of eligible individuals who were approached and informed about the study (thus had the opportunity to participate)</description>
          </group>
        </group_list>
        <measure>
          <title>3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll</title>
          <description>Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline). Qualitative information from experts and participants will be used to inform feasibility.</description>
          <population>This consists of the total number of individuals who were eligible, were approached and informed about the study, and were offered the opportunity to participate.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="93"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Enrolled</title>
                  <measurement_list>
                    <measurement group_id="O1" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Active refusal</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Passive refusal (made contact but never heard back)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Interested but unable to make groups</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program</title>
        <description>Among those who initiated the program, this is the proportion of patients who completed the program (defined as completing 6 out of 8 sessions). Qualitative information from experts and participants will be used to inform feasibility.</description>
        <time_frame>Post-treatment completion (treatment is approximately 8 weeks)</time_frame>
        <population>Total number of patients who initiated the program.</population>
        <group_list>
          <group group_id="O1">
            <title>Treatment Completers</title>
            <description>Among treatment started, this consists of all participants who completed the 3RP-AYA.</description>
          </group>
        </group_list>
        <measure>
          <title>3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program</title>
          <description>Among those who initiated the program, this is the proportion of patients who completed the program (defined as completing 6 out of 8 sessions). Qualitative information from experts and participants will be used to inform feasibility.</description>
          <population>Total number of patients who initiated the program.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Completed 6 out of 8 3RP-AYA sessions.</title>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Completed less than 6 3RP-AYA</title>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>3RP-AYA Acceptability: Five Questions</title>
        <description>Acceptability will be assessed with five questions rated on a 4-point Likert scale (1=not at all to 4=very). Items will prompt participants to rate the extent to which they found the program to be enjoyable, helpful, applicable, convenient, and satisfaction. Qualitative information from experts and patients will also inform acceptability.</description>
        <time_frame>Post-treatment completion (treatment is approximately 8 weeks)</time_frame>
        <population>These were inclusive of all responses to the acceptability items.</population>
        <group_list>
          <group group_id="O1">
            <title>Completed Post-treatment Survey Acceptability Items</title>
            <description>Denominator is the number of individuals who responded to the acceptability measure.</description>
          </group>
        </group_list>
        <measure>
          <title>3RP-AYA Acceptability: Five Questions</title>
          <description>Acceptability will be assessed with five questions rated on a 4-point Likert scale (1=not at all to 4=very). Items will prompt participants to rate the extent to which they found the program to be enjoyable, helpful, applicable, convenient, and satisfaction. Qualitative information from experts and patients will also inform acceptability.</description>
          <population>These were inclusive of all responses to the acceptability items.</population>
          <units>units 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="60"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>How enjoyable was the program</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.62" spread=".69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How helpful was the program?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.45" spread=".75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How relevant was the program?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.60" spread=".74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How convenient was the program</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.67" spread=".71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>How satisfied are you with the content?</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread=".62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events data was collected from all participants who initiated treatment (n=64) and monitored throughout the duration of the intervention.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Waitlist Control</title>
          <description>The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions&#xD;
Mini relaxation practice&#xD;
Weekly goal check-ins&#xD;
RR-practice&#xD;
Waitlist control: The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being. Waitlist control receives the adapted 3RP program (3RP-AYA) approximately 2 months after study enrollment.</description>
        </group>
        <group group_id="E2">
          <title>3RP Group Sessions</title>
          <description>The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions&#xD;
Mini relaxation practice&#xD;
Weekly goal check-ins&#xD;
RR-practice&#xD;
3RP-AYA: The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being.</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="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</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="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="33"/>
              </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>
    <point_of_contact>
      <name_or_title>Dr. Giselle K. Perez</name_or_title>
      <organization>Massachusetts General Hospital/Harvard Medical Schoool</organization>
      <phone>617-724-0765</phone>
      <email>gperez@mgh.harvard.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/NCT03768336
org study id: 18-428
secondary id: 1K07CA211955-01A1
nct id: NCT03768336
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study aims to explore the feasibility and acceptability of an adapted
      resiliency group program, called the Relaxation Response Resiliency Program (3RP-AYA), to
      reduce stress and promote stress-management among adolescents and young adults who have
      completed treatment for cancer.
The Relaxation Response Resiliency Program, or 3RP, was developed by researchers at the MGH
      Benson-Henry Institute for Mind Body Medicine. The 3RP is a group program that-through a
      variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress
      and promote psychological resiliency and physical well-being.

      The 3RP has not yet been carried out with adolescent or young adult individuals who have
      recently completed treatment for cancer. As such, the investigators have adapted the original
      3RP to target the specific needs of adolescent and young adult patients who are transitioning
      off active treatment. The investigators are conducting this study to see if the adapted
      program, the 3RP-AYA, is effective at reducing stress and stress-related symptoms for people
      of at least age 16 who have completed treatment for cancer within the past five years.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: 3RP-AYA Feasibility: Percent of Identified Eligibles Who Enroll
time frame: Post-treatment completion (treatment is approximately 8 weeks)
description: Percent of identified eligibles who were approached (hence given the opportunity to participate) who enroll (i.e., sign consent and complete baseline). Qualitative information from experts and participants will be used to inform feasibility.
measure: 3RP-AYA Feasibility: Proportion of Participants Completing the 3RP-AYA Program
time frame: Post-treatment completion (treatment is approximately 8 weeks)
description: Among those who initiated the program, this is the proportion of patients who completed the program (defined as completing 6 out of 8 sessions). Qualitative information from experts and participants will be used to inform feasibility.
measure: 3RP-AYA Acceptability: Five Questions
time frame: Post-treatment completion (treatment is approximately 8 weeks)
description: Acceptability will be assessed with five questions rated on a 4-point Likert scale (1=not at all to 4=very). Items will prompt participants to rate the extent to which they found the program to be enjoyable, helpful, applicable, convenient, and satisfaction. Qualitative information from experts and patients will also inform acceptability.
arm group label: Waitlist Control
arm group type: Active Comparator
description: The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions
Mini relaxation practice
Weekly goal check-ins
RR-practice
arm group label: 3RP Group Sessions
arm group type: Experimental
description: The 3RP-AYA will be delivered in weekly sessions over the course of approximately 8 weeks, for a total of 8 sessions
Mini relaxation practice
Weekly goal check-ins
RR-practice
intervention type: Other
intervention name: Waitlist control
description: The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being. Waitlist control receives the adapted 3RP program (3RP-AYA) approximately 2 months after study enrollment.
arm group label: Waitlist Control
intervention type: Other
intervention name: 3RP-AYA
description: The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being.
arm group label: 3RP Group Sessions
criteria: 
gender: All
minimum age: 16 Years
maximum age: 29 Years
healthy volunteers: No
last name: Giselle K. Perez, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Giselle K. Perez Lougee
investigator title: Principal Investigator
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 