<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/NCT03800758</url>
  </required_header>
  <id_info>
    <org_study_id>PRO2018-0953</org_study_id>
    <secondary_id>R01CA223963</secondary_id>
    <secondary_id>2018-1306</secondary_id>
    <nct_id>NCT03800758</nct_id>
  </id_info>
  <brief_title>Expressive Helping for Stem Cell Transplant Patients</brief_title>
  <official_title>A Randomized Controlled Trial Testing Expressive Helping for Stem Cell Transplant Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwestern University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lombardi Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hackensack Meridian Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Northwestern University</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 Writing for Insight, Strength, and Ease (WISE) Study is a multisite Randomized Controlled&#xD;
      Trial (RCT) testing the efficacy of the Expressive Helping (EH) intervention among adults&#xD;
      receiving hematopoietic stem cell transplantation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Use of stem cell transplant (mostly for hematologic cancers) is expected to increase 5-fold&#xD;
      by 2030, when the number of survivors will reach 500,000. This highly toxic treatment causes&#xD;
      a range of acute physical and psychological symptoms, which then persist for years for up to&#xD;
      45% of patients. To address gaps in existing symptom-focused behavioral interventions that&#xD;
      can be added to standard patient care, the investigators developed Expressive Helping (EH), a&#xD;
      low-cost, low-burden intervention that targets a range of physical and psychological symptoms&#xD;
      in a broad group of transplant recipients. EH is completed in 4 brief structured writing&#xD;
      sessions during and immediately after transplant, with instructions focused on having&#xD;
      participants write about their transplant experience. Based on promising preliminary data,&#xD;
      the investigators propose to determine whether EH can be used during and immediately after&#xD;
      transplant to reduce common acute physical and psychological symptoms and prevent development&#xD;
      of persistent physical and psychological symptoms. Assessments of physical symptoms and&#xD;
      psychological symptoms will occur at baseline (prior to randomization), &quot;nadir&quot; (Day 7&#xD;
      post-transplant), &quot;engraftment&quot; (Day 14 post-transplant), 1 week post-intervention, 3-months&#xD;
      post-intervention (primary endpoint, early post-transplant), 6-months post-intervention, and&#xD;
      12-months post-intervention (primary endpoint, later post-transplant). The investigators will&#xD;
      also assess a select set of potential mediators and moderators of intervention effects.&#xD;
      Participants will be adult cancer patients scheduled for allogeneic or autologous stem cell&#xD;
      transplant at the study sites. After screening and consent, eligible patients will be&#xD;
      enrolled in a parallel-group, 1:1 randomized controlled trial. Randomization will be&#xD;
      stratified by study site (JTCC, Lombardi Comprehensive Cancer Center, LCCC, or Robert H.&#xD;
      Lurie Comprehensive Cancer Center, RHLCCC); sex (linked with patient outcomes), age (18-59, ≥&#xD;
      60), and transplant type (autologous, allogeneic). Staff performing assessments will be blind&#xD;
      to study assignment. Participants cannot be blinded, but hypotheses will not be revealed to&#xD;
      them until trial completion. They will be asked not to reveal their assignment to staff.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 6, 2019</start_date>
  <completion_date type="Actual">April 24, 2023</completion_date>
  <primary_completion_date type="Actual">April 24, 2023</primary_completion_date>
  <phase>Phase 3</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptom severity: Changes in symptom burden</measure>
    <time_frame>Baseline to 3-months post intervention</time_frame>
    <description>MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0=&quot;not present&quot; to 10=&quot;As bad as you can imagine&quot;) to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptom severity: Changes in symptom burden</measure>
    <time_frame>Baseline to 12-months post-intervention</time_frame>
    <description>MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0=&quot;not present&quot; to 10=&quot;As bad as you can imagine&quot;) to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Symptom severity: Changes in symptom burden</measure>
    <time_frame>Baseline to Day 7 post-transplant</time_frame>
    <description>MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0=&quot;not present&quot; to 10=&quot;As bad as you can imagine&quot;) to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom severity: Changes in symptom burden</measure>
    <time_frame>Baseline to Day 14 post-transplant</time_frame>
    <description>MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0=&quot;not present&quot; to 10=&quot;As bad as you can imagine&quot;) to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom severity: Changes in symptom burden</measure>
    <time_frame>Baseline to 1-week post-intervention</time_frame>
    <description>MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0=&quot;not present&quot; to 10=&quot;As bad as you can imagine&quot;) to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom severity: Changes in symptom burden</measure>
    <time_frame>Baseline to 6-months post-intervention</time_frame>
    <description>MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0=&quot;not present&quot; to 10=&quot;As bad as you can imagine&quot;) to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms: Changes in depressive symptoms</measure>
    <time_frame>Baseline to Day 7 post-transplant</time_frame>
    <description>Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = &quot;Rarely or None of the Time,&quot; 1 = &quot;Some or Little of the Time,&quot; 2 = &quot;Moderately or Much of the time,&quot; 3 = &quot;Most or Almost All the Time&quot;). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms: Changes in depressive symptoms</measure>
    <time_frame>Baseline to Day 14 post-transplant</time_frame>
    <description>Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = &quot;Rarely or None of the Time,&quot; 1 = &quot;Some or Little of the Time,&quot; 2 = &quot;Moderately or Much of the time,&quot; 3 = &quot;Most or Almost All the Time&quot;). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms: Changes in depressive symptoms</measure>
    <time_frame>Baseline to 1-week post-intervention</time_frame>
    <description>Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = &quot;Rarely or None of the Time,&quot; 1 = &quot;Some or Little of the Time,&quot; 2 = &quot;Moderately or Much of the time,&quot; 3 = &quot;Most or Almost All the Time&quot;). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms: Changes in depressive symptoms</measure>
    <time_frame>Baseline to 3-months post-intervention</time_frame>
    <description>Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = &quot;Rarely or None of the Time,&quot; 1 = &quot;Some or Little of the Time,&quot; 2 = &quot;Moderately or Much of the time,&quot; 3 = &quot;Most or Almost All the Time&quot;). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms: Changes in depressive symptoms</measure>
    <time_frame>Baseline to 6-months post-intervention</time_frame>
    <description>Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = &quot;Rarely or None of the Time,&quot; 1 = &quot;Some or Little of the Time,&quot; 2 = &quot;Moderately or Much of the time,&quot; 3 = &quot;Most or Almost All the Time&quot;). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depressive symptoms: Changes in depressive symptoms</measure>
    <time_frame>Baseline to 12-months post-intervention</time_frame>
    <description>Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = &quot;Rarely or None of the Time,&quot; 1 = &quot;Some or Little of the Time,&quot; 2 = &quot;Moderately or Much of the time,&quot; 3 = &quot;Most or Almost All the Time&quot;). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety: Changes in symptoms of generalized anxiety</measure>
    <time_frame>Baseline to Day 7 post-transplant</time_frame>
    <description>Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0=&quot;Not at all,&quot; 1=&quot;Several days,&quot; 2=&quot;More than half the days,&quot; 3=&quot;Nearly every day&quot;). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety: Changes in symptoms of generalized anxiety</measure>
    <time_frame>Baseline to Day 14 post-transplant</time_frame>
    <description>Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0=&quot;Not at all,&quot; 1=&quot;Several days,&quot; 2=&quot;More than half the days,&quot; 3=&quot;Nearly every day&quot;). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety: Changes in symptoms of generalized anxiety</measure>
    <time_frame>Baseline to 1-week post-intervention</time_frame>
    <description>Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0=&quot;Not at all,&quot; 1=&quot;Several days,&quot; 2=&quot;More than half the days,&quot; 3=&quot;Nearly every day&quot;). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety: Changes in symptoms of generalized anxiety</measure>
    <time_frame>Baseline to 3-months post-intervention</time_frame>
    <description>Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0=&quot;Not at all,&quot; 1=&quot;Several days,&quot; 2=&quot;More than half the days,&quot; 3=&quot;Nearly every day&quot;). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety: Changes in symptoms of generalized anxiety</measure>
    <time_frame>Baseline to 6-months post-intervention</time_frame>
    <description>Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0=&quot;Not at all,&quot; 1=&quot;Several days,&quot; 2=&quot;More than half the days,&quot; 3=&quot;Nearly every day&quot;). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Generalized Anxiety: Changes in symptoms of generalized anxiety</measure>
    <time_frame>Baseline to 12-months post-intervention</time_frame>
    <description>Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0=&quot;Not at all,&quot; 1=&quot;Several days,&quot; 2=&quot;More than half the days,&quot; 3=&quot;Nearly every day&quot;). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety</measure>
    <time_frame>Baseline to Day 7 post-transplant</time_frame>
    <description>Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety</measure>
    <time_frame>Baseline to Day 14 post-transplant</time_frame>
    <description>Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety</measure>
    <time_frame>Baseline to 1-week post-intervention</time_frame>
    <description>Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety</measure>
    <time_frame>Baseline to 3-months post-intervention</time_frame>
    <description>Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety</measure>
    <time_frame>Baseline to 6-months post-intervention</time_frame>
    <description>Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety</measure>
    <time_frame>Baseline to 12-months post-intervention</time_frame>
    <description>Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 (&quot;not at all&quot;) to 4 (&quot;extremely&quot;). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life: Changes in quality of life</measure>
    <time_frame>Baseline to Day 7 post-transplant</time_frame>
    <description>Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life: Changes in quality of life</measure>
    <time_frame>Baseline to Day 14 post-transplant</time_frame>
    <description>Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life: Changes in quality of life</measure>
    <time_frame>Baseline to 1-week post-intervention</time_frame>
    <description>Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life: Changes in quality of life</measure>
    <time_frame>Baseline to 3-months post-intervention</time_frame>
    <description>Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life: Changes in quality of life</measure>
    <time_frame>Baseline to 6-months post-intervention</time_frame>
    <description>Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life: Changes in quality of life</measure>
    <time_frame>Baseline to 12-months post-intervention</time_frame>
    <description>Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue: Changes in fatigue</measure>
    <time_frame>Baseline to Day 7 post-transplant</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0=&quot;Not at all,&quot; 1=&quot;A little bit,&quot; 2=&quot;Somewhat,&quot; 3=&quot;Quite a bit,&quot; 4=&quot;Very much&quot;). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue: Changes in fatigue</measure>
    <time_frame>Baseline to Day 14 post-transplant</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0=&quot;Not at all,&quot; 1=&quot;A little bit,&quot; 2=&quot;Somewhat,&quot; 3=&quot;Quite a bit,&quot; 4=&quot;Very much&quot;). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue: Changes in fatigue</measure>
    <time_frame>Baseline to 1-week post-intervention</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0=&quot;Not at all,&quot; 1=&quot;A little bit,&quot; 2=&quot;Somewhat,&quot; 3=&quot;Quite a bit,&quot; 4=&quot;Very much&quot;). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue: Changes in fatigue</measure>
    <time_frame>Baseline to 3-month post-intervention</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0=&quot;Not at all,&quot; 1=&quot;A little bit,&quot; 2=&quot;Somewhat,&quot; 3=&quot;Quite a bit,&quot; 4=&quot;Very much&quot;). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue: Changes in fatigue</measure>
    <time_frame>Baseline to 6-month post-intervention</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0=&quot;Not at all,&quot; 1=&quot;A little bit,&quot; 2=&quot;Somewhat,&quot; 3=&quot;Quite a bit,&quot; 4=&quot;Very much&quot;). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fatigue: Changes in fatigue</measure>
    <time_frame>Baseline to 12-month post-intervention</time_frame>
    <description>Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0=&quot;Not at all,&quot; 1=&quot;A little bit,&quot; 2=&quot;Somewhat,&quot; 3=&quot;Quite a bit,&quot; 4=&quot;Very much&quot;). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">405</enrollment>
  <condition>Stem Cell Transplantation</condition>
  <condition>Hematologic Malignancy</condition>
  <arm_group>
    <arm_group_label>Expressive Helping writing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Writing sessions 1-3: Participants complete one 20-minute expressive writing session at three time points: 1) after hospitalization but prior to transplant infusion, (2) approximately 3 days after hospital discharge, and (3) approximately 2 weeks after completion of writing session 2.&#xD;
Writing session 4: One 20-40 minute peer support writing session about 1 week after completion of writing session 3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Factual Writing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Writing sessions 1-3: Participants complete one 20-minute factual session at three time points: 1) after hospitalization but prior to transplant infusion, (2) approximately 3 days after hospital discharge, and (3) approximately 2 weeks after completion of writing session 2.&#xD;
Writing session 4: One 20-40 minute factual writing session about 1 week after completion of writing session 3.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Expressive Helping</intervention_name>
    <description>Expressive Helping (EH) is completed in 4 brief structured writing sessions during and immediately after transplant, with instructions focused on having participants write about their transplant experience using previously-tested EH instructions, adapted for this population.</description>
    <arm_group_label>Expressive Helping writing</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Factual Writing</intervention_name>
    <description>Factual Writing has been used with cancer patients and in the investigators' prior EH trial. It is completed in 4 brief structured writing sessions during and immediately after transplant, with instructions focused on having participants write about their transplant experience using standard Factual Writing instructions.</description>
    <arm_group_label>Factual Writing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cancer patients&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  English proficient&#xD;
&#xD;
          -  Scheduled for allogeneic or autologous transplant at JTCC, LCCC, or RHLCC.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current participation in a behavioral intervention targeting symptoms or quality of&#xD;
             life&#xD;
&#xD;
          -  Cognitive or psychiatric impairment precluding ability to complete informed consent or&#xD;
             study procedures&#xD;
&#xD;
          -  Literacy limitations precluding completion of a writing study&#xD;
&#xD;
          -  Undergoing a tandem transplant where participant is now completing the first of two or&#xD;
             more planned transplants&#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>Lombardi Comprehensive Cancer Center at Georgetown University Medical Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert H. Lurie Comprehensive Cancer Center at Northwestern University</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Theurer Cancer Center at Hackensack University Medical Center</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 8, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>May 3, 2023</last_update_submitted>
  <last_update_submitted_qc>May 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwestern University</investigator_affiliation>
    <investigator_full_name>Christine Rini, PhD</investigator_full_name>
    <investigator_title>Director, Cancer Survivorship Institute, Robert H. Lurie Comprehensive Cancer Center</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hematologic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>All IPD will be protected and maintained by the study team</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 23, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03800758/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03800758
org study id: PRO2018-0953
secondary id: R01CA223963
secondary id: 2018-1306
nct id: NCT03800758
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Writing for Insight, Strength, and Ease (WISE) Study is a multisite Randomized Controlled
      Trial (RCT) testing the efficacy of the Expressive Helping (EH) intervention among adults
      receiving hematopoietic stem cell transplantation.
Use of stem cell transplant (mostly for hematologic cancers) is expected to increase 5-fold
      by 2030, when the number of survivors will reach 500,000. This highly toxic treatment causes
      a range of acute physical and psychological symptoms, which then persist for years for up to
      45% of patients. To address gaps in existing symptom-focused behavioral interventions that
      can be added to standard patient care, the investigators developed Expressive Helping (EH), a
      low-cost, low-burden intervention that targets a range of physical and psychological symptoms
      in a broad group of transplant recipients. EH is completed in 4 brief structured writing
      sessions during and immediately after transplant, with instructions focused on having
      participants write about their transplant experience. Based on promising preliminary data,
      the investigators propose to determine whether EH can be used during and immediately after
      transplant to reduce common acute physical and psychological symptoms and prevent development
      of persistent physical and psychological symptoms. Assessments of physical symptoms and
      psychological symptoms will occur at baseline (prior to randomization), "nadir" (Day 7
      post-transplant), "engraftment" (Day 14 post-transplant), 1 week post-intervention, 3-months
      post-intervention (primary endpoint, early post-transplant), 6-months post-intervention, and
      12-months post-intervention (primary endpoint, later post-transplant). The investigators will
      also assess a select set of potential mediators and moderators of intervention effects.
      Participants will be adult cancer patients scheduled for allogeneic or autologous stem cell
      transplant at the study sites. After screening and consent, eligible patients will be
      enrolled in a parallel-group, 1:1 randomized controlled trial. Randomization will be
      stratified by study site (JTCC, Lombardi Comprehensive Cancer Center, LCCC, or Robert H.
      Lurie Comprehensive Cancer Center, RHLCCC); sex (linked with patient outcomes), age (18-59, ≥
      60), and transplant type (autologous, allogeneic). Staff performing assessments will be blind
      to study assignment. Participants cannot be blinded, but hypotheses will not be revealed to
      them until trial completion. They will be asked not to reveal their assignment to staff.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Outcomes Assessor)
measure: Symptom severity: Changes in symptom burden
time frame: Baseline to 3-months post intervention
description: MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0="not present" to 10="As bad as you can imagine") to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.
measure: Symptom severity: Changes in symptom burden
time frame: Baseline to 12-months post-intervention
description: MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0="not present" to 10="As bad as you can imagine") to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.
measure: Symptom severity: Changes in symptom burden
time frame: Baseline to Day 7 post-transplant
description: MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0="not present" to 10="As bad as you can imagine") to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.
measure: Symptom severity: Changes in symptom burden
time frame: Baseline to Day 14 post-transplant
description: MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0="not present" to 10="As bad as you can imagine") to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.
measure: Symptom severity: Changes in symptom burden
time frame: Baseline to 1-week post-intervention
description: MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0="not present" to 10="As bad as you can imagine") to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.
measure: Symptom severity: Changes in symptom burden
time frame: Baseline to 6-months post-intervention
description: MD Anderson Symptom Inventory-Bone Marrow Transplant (MDASI-BMT), which measures both the severity of and interference caused by 13 symptoms, plus 5 transplant-specific symptoms. Symptom severity is rated on a 0-10 scale (0="not present" to 10="As bad as you can imagine") to indicate the severity of symptoms in the past 24 hours. The mean of items are calculated to yield a symptom severity score in which higher scores indicate higher severity.
measure: Depressive symptoms: Changes in depressive symptoms
time frame: Baseline to Day 7 post-transplant
description: Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = "Rarely or None of the Time," 1 = "Some or Little of the Time," 2 = "Moderately or Much of the time," 3 = "Most or Almost All the Time"). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.
measure: Depressive symptoms: Changes in depressive symptoms
time frame: Baseline to Day 14 post-transplant
description: Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = "Rarely or None of the Time," 1 = "Some or Little of the Time," 2 = "Moderately or Much of the time," 3 = "Most or Almost All the Time"). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.
measure: Depressive symptoms: Changes in depressive symptoms
time frame: Baseline to 1-week post-intervention
description: Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = "Rarely or None of the Time," 1 = "Some or Little of the Time," 2 = "Moderately or Much of the time," 3 = "Most or Almost All the Time"). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.
measure: Depressive symptoms: Changes in depressive symptoms
time frame: Baseline to 3-months post-intervention
description: Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = "Rarely or None of the Time," 1 = "Some or Little of the Time," 2 = "Moderately or Much of the time," 3 = "Most or Almost All the Time"). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.
measure: Depressive symptoms: Changes in depressive symptoms
time frame: Baseline to 6-months post-intervention
description: Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = "Rarely or None of the Time," 1 = "Some or Little of the Time," 2 = "Moderately or Much of the time," 3 = "Most or Almost All the Time"). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.
measure: Depressive symptoms: Changes in depressive symptoms
time frame: Baseline to 12-months post-intervention
description: Center for Epidemiologic Studies Depression Scale (CES-D), is a 20-item measure that asks respondents to rate how often over the past week they experienced symptoms associated with depression on a scale from 0 to 3 (0 = "Rarely or None of the Time," 1 = "Some or Little of the Time," 2 = "Moderately or Much of the time," 3 = "Most or Almost All the Time"). Scores are summed and range from 0 to 60, with high scores indicating greater depressive symptoms.
measure: Generalized Anxiety: Changes in symptoms of generalized anxiety
time frame: Baseline to Day 7 post-transplant
description: Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0="Not at all," 1="Several days," 2="More than half the days," 3="Nearly every day"). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.
measure: Generalized Anxiety: Changes in symptoms of generalized anxiety
time frame: Baseline to Day 14 post-transplant
description: Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0="Not at all," 1="Several days," 2="More than half the days," 3="Nearly every day"). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.
measure: Generalized Anxiety: Changes in symptoms of generalized anxiety
time frame: Baseline to 1-week post-intervention
description: Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0="Not at all," 1="Several days," 2="More than half the days," 3="Nearly every day"). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.
measure: Generalized Anxiety: Changes in symptoms of generalized anxiety
time frame: Baseline to 3-months post-intervention
description: Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0="Not at all," 1="Several days," 2="More than half the days," 3="Nearly every day"). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.
measure: Generalized Anxiety: Changes in symptoms of generalized anxiety
time frame: Baseline to 6-months post-intervention
description: Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0="Not at all," 1="Several days," 2="More than half the days," 3="Nearly every day"). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.
measure: Generalized Anxiety: Changes in symptoms of generalized anxiety
time frame: Baseline to 12-months post-intervention
description: Generalized Anxiety Disorder Screener (GAD-7), which measures generalized anxiety symptoms in the past 7 days with 7 items rated on a 0-3 scale (0="Not at all," 1="Several days," 2="More than half the days," 3="Nearly every day"). Scores are summed and range from 0 to 21, with higher scores indicating greater symptomatology.
measure: Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
time frame: Baseline to Day 7 post-transplant
description: Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.
measure: Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
time frame: Baseline to Day 14 post-transplant
description: Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.
measure: Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
time frame: Baseline to 1-week post-intervention
description: Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.
measure: Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
time frame: Baseline to 3-months post-intervention
description: Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.
measure: Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
time frame: Baseline to 6-months post-intervention
description: Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.
measure: Cancer-specific anxiety: Changes in symptoms of cancer-specific anxiety
time frame: Baseline to 12-months post-intervention
description: Impact of event scale (IES), which includes 15 items that assess difficulties (intrusive thoughts and feelings, avoidance) caused by a traumatic event (in this study, the diagnosis and transplant). Respondents rate how much they were distressed or bothered by each difficulty during the past 7 days using a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Responses are summed to give a total score ranging from 0 to 60, with higher scores indicating greater symptomatology.
measure: Quality of life: Changes in quality of life
time frame: Baseline to Day 7 post-transplant
description: Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life
measure: Quality of life: Changes in quality of life
time frame: Baseline to Day 14 post-transplant
description: Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life
measure: Quality of life: Changes in quality of life
time frame: Baseline to 1-week post-intervention
description: Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life
measure: Quality of life: Changes in quality of life
time frame: Baseline to 3-months post-intervention
description: Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life
measure: Quality of life: Changes in quality of life
time frame: Baseline to 6-months post-intervention
description: Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life
measure: Quality of life: Changes in quality of life
time frame: Baseline to 12-months post-intervention
description: Patient-reported Outcomes Measurement Information System (PROMIS) V1.2 Global Health measure, which includes 10 items assessing the domains of physical and mental health functioning, rated on a scale from 1-5 or 0 to 10, with specific responses differing across items. Items are summed and conversion tables are used to convert the simple summed raw scores into T-score values for each respondent. T-Score distributions are standardized such that a 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. Higher scores indicate better quality of life
measure: Fatigue: Changes in fatigue
time frame: Baseline to Day 7 post-transplant
description: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," 4="Very much"). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.
measure: Fatigue: Changes in fatigue
time frame: Baseline to Day 14 post-transplant
description: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," 4="Very much"). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.
measure: Fatigue: Changes in fatigue
time frame: Baseline to 1-week post-intervention
description: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," 4="Very much"). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.
measure: Fatigue: Changes in fatigue
time frame: Baseline to 3-month post-intervention
description: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," 4="Very much"). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.
measure: Fatigue: Changes in fatigue
time frame: Baseline to 6-month post-intervention
description: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," 4="Very much"). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.
measure: Fatigue: Changes in fatigue
time frame: Baseline to 12-month post-intervention
description: Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), which measures level of fatigue in the past 7 days with 13 items rated on a 0-4 scale (0="Not at all," 1="A little bit," 2="Somewhat," 3="Quite a bit," 4="Very much"). Eleven responses are reverse scored and responses are then averaged to yield a scale ranging from 0 to 52, in which higher scores indicate lower fatigue.
arm group label: Expressive Helping writing
arm group type: Experimental
description: Writing sessions 1-3: Participants complete one 20-minute expressive writing session at three time points: 1) after hospitalization but prior to transplant infusion, (2) approximately 3 days after hospital discharge, and (3) approximately 2 weeks after completion of writing session 2.
Writing session 4: One 20-40 minute peer support writing session about 1 week after completion of writing session 3.
arm group label: Factual Writing
arm group type: Active Comparator
description: Writing sessions 1-3: Participants complete one 20-minute factual session at three time points: 1) after hospitalization but prior to transplant infusion, (2) approximately 3 days after hospital discharge, and (3) approximately 2 weeks after completion of writing session 2.
Writing session 4: One 20-40 minute factual writing session about 1 week after completion of writing session 3.
intervention type: Behavioral
intervention name: Expressive Helping
description: Expressive Helping (EH) is completed in 4 brief structured writing sessions during and immediately after transplant, with instructions focused on having participants write about their transplant experience using previously-tested EH instructions, adapted for this population.
arm group label: Expressive Helping writing
intervention type: Behavioral
intervention name: Factual Writing
description: Factual Writing has been used with cancer patients and in the investigators' prior EH trial. It is completed in 4 brief structured writing sessions during and immediately after transplant, with instructions focused on having participants write about their transplant experience using standard Factual Writing instructions.
arm group label: Factual Writing
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Northwestern University
investigator full name: Christine Rini, PhD
investigator title: Director, Cancer Survivorship Institute, Robert H. Lurie Comprehensive Cancer Center
mesh term: Hematologic Neoplasms
sharing ipd: No
ipd description: All IPD will be protected and maintained by the study team
provided document: 