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/NCT06010017</url>
    </required_header>
    <id_info>
      <org_study_id>23-132</org_study_id>
      <nct_id>NCT06010017</nct_id>
    </id_info>
    <brief_title>Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation</brief_title>
    <acronym>STEPP</acronym>
    <official_title>Peer Support Intervention for Patients Undergoing Hematopoietic Stem Cell Transplantation (STEPP): Feasibility and Preliminary Efficacy Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Dana-Farber Cancer Institute</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Dana-Farber Cancer Institute</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>
        The main purpose of this study is to determine if a novel peer support intervention (STEPP)&#xD;
        is feasible among patients undergoing hematopoietic stem cell transplantation (HSCT).&#xD;
  &#xD;
        The name of the intervention used in this research study is STEPP, a peer support&#xD;
        intervention comprised of five learning modules on psychoeducation and supportive&#xD;
        psychotherapy strategies, tailored to the unique needs of patients undergoing HSCT.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The goal of this project is to refine a peer support intervention (STEPP) for patients&#xD;
        undergoing hematopoietic stem cell transplantation (HSCT) and to conduct a randomized&#xD;
        clinical trial to test its feasibility and preliminary efficacy for improving quality of life&#xD;
        (QOL) and reducing psychological distress.&#xD;
  &#xD;
        Participants will be randomized into one of two study groups: Peer Support Intervention&#xD;
        (STEPP) vs. Usual Care. Randomization means a participant is placed into a group by chance.&#xD;
        Participants will have an equal chance of being placed in either group.&#xD;
  &#xD;
        Study procedures include screening for eligibility and questionnaires.&#xD;
  &#xD;
        Participation in this study is expected to last about 24 weeks.&#xD;
  &#xD;
        It is expected that about 80 people will participate in this randomized clinical trial.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">February 2024</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2025</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>Feasibility of STEPP</measure>
      <time_frame>Up to 5 weeks</time_frame>
      <description>The proposed STEPP intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study, and of those enrolled and randomized to the intervention, at least 60% complete at least 3/5 of the intervention sessions.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Acceptability of STEPP</measure>
      <time_frame>Up to Day +60 (+/- 10 days)</time_frame>
      <description>The 8-item Client Satisfaction Questionnaire (CSQ) will assess patient satisfaction with the STEPP intervention. Each question is scored from 0-4 to result in a total of 0-24. Higher scores indicate increased acceptability of the intervention. Acceptability will also be assessed using weekly ratings of ease and utility of each intervention session (0=very difficult/not helpful; 10=very easy/very helpful). The mean ease and utility of each exercise and overall will be calculated, and will use a threshold of a mean combined score of 7.0/10 for acceptability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Anxiety Symptoms</measure>
      <time_frame>Up to Day +100 (+/- 10 days)</time_frame>
      <description>The Hospital Anxiety Subscale (HADS), comprised of 7 items, will assess symptoms of anxiety in all study participants during the past week. The questionnaire consists of a four-point item response form that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety. The mean anxiety score will be reported for each cohort.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life Longitudinally</measure>
      <time_frame>Up to Day +100 (+/- 10 days)</time_frame>
      <description>The 45-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) will assess quality of life (QOL) by cohort. The FACT-BMT consists of five subscales assessing well-being across four domains (physical, functional, emotional, social, and bone marrow transplant symptoms). Each question is scored from 0 (&quot;Not at all&quot;) to 4 (&quot;Very Much&quot;). The final score will be presented as a percentage, calculated by tallying the total score out of 180. A higher score coincides with a better quality of life. The mean QOL score will be reported for each cohort.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Depression Symptoms</measure>
      <time_frame>Up to Day +100 (+/- 10 days)</time_frame>
      <description>Assessed by the Hospital Depression Subscale (HADs) and Patient Health Questionnaire-9 (PHQ-9). The Hospital Depression Subscale (HADS), comprised of 7 items, will assess symptoms of depression in all study participants during the past week. The questionnaire consists of a four-point item response form that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant depression. The PHQ-9 is a 9-item measure that measures participant symptoms over the previous two weeks. Answers range from 0 to 3 with 0 representing &quot;Not At All&quot; to 3 representing &quot;Nearly Every Day.&quot; A higher total score represents a greater severity of depression. The mean depression score will be reported for each cohort.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Post-Traumatic Stress Disorder (PTSD)</measure>
      <time_frame>Up to Day +100 (+/- 10 days)</time_frame>
      <description>The mean score for post-traumatic stress disorder (PTSD) will be reported by cohort. It will be evaluated using the Post-Traumatic Stress Disorder Checklist - Civilian Version (PCL-C) to assess symptoms of post-traumatic stress in participants. The PCL is a 17 item self-reported measure that evaluates symptoms of post-traumatic stress disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders-IV. Each item is scored from 1-5 for a total of 185 potential points. A higher score indicates higher levels of PTSD.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Hematopoietic Neoplasms</condition>
    <condition>Hematopoietic Malignancy</condition>
    <arm_group>
      <arm_group_label>STEPP</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be randomized in 1:1 fashion, stratified by transplant type (autologous vs. allogeneic), and will complete study procedures as follows:&#xD;
  Baseline self-reported assessment (in-person or remotely).&#xD;
  Virtual, STEPP intervention sessions 1x weekly for five weeks with peer mentor.&#xD;
  HSCT and hospitalization per standard of care.&#xD;
  Day +60 (+/- 10 days) and Day +100 (+/- 10 days) self-reported assessments.&#xD;
  Optional exit interview with study staff (10-20 participants).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Usual Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants will be randomized in 1:1 fashion, stratified by transplant type (autologous vs. allogeneic), and will complete study procedures as follows:&#xD;
  Baseline self-reported assessment.&#xD;
  HSCT and hospitalization per standard of care.&#xD;
  Day +60 (+/- 10 days) and Day +100 (+/- 10 days) self-reported assessments.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>STEPP Intervention</intervention_name>
      <description>Peer support intervention comprised of five learning modules on psychoeducation and supportive psychotherapy strategies, via virtual platform. If participants do not have a smart device, one will be provided by the study team.</description>
      <arm_group_label>STEPP</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients (age &gt; 18 years) with a hematologic malignancy undergoing autologous or&#xD;
               allogeneic HSCT.&#xD;
  &#xD;
            -  Ability to comprehend, read, and respond to questions in English as STEPP is only&#xD;
               available in English.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients undergoing HSCT for benign hematologic conditions.&#xD;
  &#xD;
            -  Patients undergoing outpatient HSCT.&#xD;
  &#xD;
            -  Patients with acute or unstable psychiatric or cognitive conditions which the treating&#xD;
               clinicians believes prohibits informed consent or compliance with study procedures.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hermioni Amonoo, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Dana-Farber Cancer Institute</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hermioni Amonoo, MD</last_name>
      <phone>617-732-4241</phone>
      <email>hermioni_amonoo@dfci.harvard.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Dana-Farber Cancer Institute</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02115</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Brigham and Women's Hospital</name>
        <address>
          <city>Boston</city>
          <state>Massachusetts</state>
          <zip>02215</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Hermioni Amonoo, MD</last_name>
        <phone>617-732-4241</phone>
        <email>hermioni_lokko@dfci.harvard.edu</email>
      </contact>
      <investigator>
        <last_name>Hermioni Amonoo, 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>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 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>Hermioni Amonoo, MD, MPP</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <keyword>Hematopoietic Neoplasms</keyword>
    <keyword>Hematopoietic Malignancy</keyword>
    <keyword>HSCT</keyword>
    <keyword>Hematopoietic Stem Cell Transplantation</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neoplasms</mesh_term>
      <mesh_term>Hematologic Neoplasms</mesh_term>
    </condition_browse>
    <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 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/NCT06010017
  org study id: 23-132
  nct id: NCT06010017
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The main purpose of this study is to determine if a novel peer support intervention (STEPP)
        is feasible among patients undergoing hematopoietic stem cell transplantation (HSCT).
  
        The name of the intervention used in this research study is STEPP, a peer support
        intervention comprised of five learning modules on psychoeducation and supportive
        psychotherapy strategies, tailored to the unique needs of patients undergoing HSCT.
  The goal of this project is to refine a peer support intervention (STEPP) for patients
        undergoing hematopoietic stem cell transplantation (HSCT) and to conduct a randomized
        clinical trial to test its feasibility and preliminary efficacy for improving quality of life
        (QOL) and reducing psychological distress.
  
        Participants will be randomized into one of two study groups: Peer Support Intervention
        (STEPP) vs. Usual Care. Randomization means a participant is placed into a group by chance.
        Participants will have an equal chance of being placed in either group.
  
        Study procedures include screening for eligibility and questionnaires.
  
        Participation in this study is expected to last about 24 weeks.
  
        It is expected that about 80 people will participate in this randomized clinical trial.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Feasibility of STEPP
  time frame: Up to 5 weeks
  description: The proposed STEPP intervention will be deemed feasible if at least 60% of eligible patients are enrolled in the study, and of those enrolled and randomized to the intervention, at least 60% complete at least 3/5 of the intervention sessions.
  measure: Acceptability of STEPP
  time frame: Up to Day +60 (+/- 10 days)
  description: The 8-item Client Satisfaction Questionnaire (CSQ) will assess patient satisfaction with the STEPP intervention. Each question is scored from 0-4 to result in a total of 0-24. Higher scores indicate increased acceptability of the intervention. Acceptability will also be assessed using weekly ratings of ease and utility of each intervention session (0=very difficult/not helpful; 10=very easy/very helpful). The mean ease and utility of each exercise and overall will be calculated, and will use a threshold of a mean combined score of 7.0/10 for acceptability.
  measure: Anxiety Symptoms
  time frame: Up to Day +100 (+/- 10 days)
  description: The Hospital Anxiety Subscale (HADS), comprised of 7 items, will assess symptoms of anxiety in all study participants during the past week. The questionnaire consists of a four-point item response form that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant anxiety. The mean anxiety score will be reported for each cohort.
  measure: Quality of Life Longitudinally
  time frame: Up to Day +100 (+/- 10 days)
  description: The 45-item Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) will assess quality of life (QOL) by cohort. The FACT-BMT consists of five subscales assessing well-being across four domains (physical, functional, emotional, social, and bone marrow transplant symptoms). Each question is scored from 0 ("Not at all") to 4 ("Very Much"). The final score will be presented as a percentage, calculated by tallying the total score out of 180. A higher score coincides with a better quality of life. The mean QOL score will be reported for each cohort.
  measure: Depression Symptoms
  time frame: Up to Day +100 (+/- 10 days)
  description: Assessed by the Hospital Depression Subscale (HADs) and Patient Health Questionnaire-9 (PHQ-9). The Hospital Depression Subscale (HADS), comprised of 7 items, will assess symptoms of depression in all study participants during the past week. The questionnaire consists of a four-point item response form that quantifies the degree to which participants experience mood symptoms. Scores on each subscale range from 0 to 21, with a cutoff of 8 or greater denoting clinically significant depression. The PHQ-9 is a 9-item measure that measures participant symptoms over the previous two weeks. Answers range from 0 to 3 with 0 representing "Not At All" to 3 representing "Nearly Every Day." A higher total score represents a greater severity of depression. The mean depression score will be reported for each cohort.
  measure: Post-Traumatic Stress Disorder (PTSD)
  time frame: Up to Day +100 (+/- 10 days)
  description: The mean score for post-traumatic stress disorder (PTSD) will be reported by cohort. It will be evaluated using the Post-Traumatic Stress Disorder Checklist - Civilian Version (PCL-C) to assess symptoms of post-traumatic stress in participants. The PCL is a 17 item self-reported measure that evaluates symptoms of post-traumatic stress disorder according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders-IV. Each item is scored from 1-5 for a total of 185 potential points. A higher score indicates higher levels of PTSD.
  arm group label: STEPP
  arm group type: Experimental
  description: Participants will be randomized in 1:1 fashion, stratified by transplant type (autologous vs. allogeneic), and will complete study procedures as follows:
  Baseline self-reported assessment (in-person or remotely).
  Virtual, STEPP intervention sessions 1x weekly for five weeks with peer mentor.
  HSCT and hospitalization per standard of care.
  Day +60 (+/- 10 days) and Day +100 (+/- 10 days) self-reported assessments.
  Optional exit interview with study staff (10-20 participants).
  arm group label: Usual Care
  arm group type: No Intervention
  description: Participants will be randomized in 1:1 fashion, stratified by transplant type (autologous vs. allogeneic), and will complete study procedures as follows:
  Baseline self-reported assessment.
  HSCT and hospitalization per standard of care.
  Day +60 (+/- 10 days) and Day +100 (+/- 10 days) self-reported assessments.
  intervention type: Behavioral
  intervention name: STEPP Intervention
  description: Peer support intervention comprised of five learning modules on psychoeducation and supportive psychotherapy strategies, via virtual platform. If participants do not have a smart device, one will be provided by the study team.
  arm group label: STEPP
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Hermioni Amonoo, MD
  role: Principal Investigator
  affiliation: Dana-Farber Cancer Institute
  last name: Hermioni Amonoo, MD
  phone: 617-732-4241
  email: hermioni_amonoo@dfci.harvard.edu
  facility: 
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Dana-Farber Cancer Institute
  investigator full name: Hermioni Amonoo, MD, MPP
  investigator title: Principal Investigator
  mesh term: Neoplasms
  mesh term: Hematologic Neoplasms
  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 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