<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/NCT04423939</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00105683</org_study_id>
    <nct_id>NCT04423939</nct_id>
  </id_info>
  <brief_title>ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients</brief_title>
  <official_title>ACT to Reduce Morbidity and Mortality in Hematopoietic Stem Cell Transplant (HCT) Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a research study to develop and test a novel protocol to reduce physical and&#xD;
      psychological vulnerabilities that contribute to treatment intolerance and treatment-related&#xD;
      morbidity and mortality among hematopoietic stem cell transplant (HCT) patients. When the&#xD;
      participant enrolls in this study, they will be asked to participate in acceptance and&#xD;
      commitment therapy (ACT) as well as complete in-person physical function tests and a&#xD;
      cognitive test. They will also receive training on how to use iOS devices (e.g. iPad, iPhone)&#xD;
      and activity trackers (e.g. Apple Watch), which will be provided to them during the duration&#xD;
      of study participation. The study team will ask you to complete multiple surveys about&#xD;
      emotional and cognitive function, diet and social support, and ask the participant to provide&#xD;
      feedback about the treatment (e.g., what they liked or did not like). The study team will&#xD;
      also ask the participant to provide stool samples for analysis of the bacteria in intestines,&#xD;
      skin surface swabs for analysis of the bacteria on skin and blood samples for analysis of&#xD;
      biomarkers and metabolites. Biomarkers and metabolites are molecular and cellular parts that&#xD;
      deal with genetic makeup, like DNA, RNA, protein, and/or other naturally occurring substances&#xD;
      that may be associated with transplant outcomes. Participants can expect to be enrolled in&#xD;
      this study for 3 years.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 14, 2020</start_date>
  <completion_date type="Anticipated">February 17, 2025</completion_date>
  <primary_completion_date type="Actual">May 19, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-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>Change in physical function, as measured by 6 minute walk test</measure>
    <time_frame>Baseline, Day 90</time_frame>
    <description>The baseline for each patient is made through an algorithm that factors the patients age and gender. The patient's score is compared to what a person that is the patient's same age and gender would get. This comparison is then used as a tool to assess aerobic capacity or endurance.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospital length of stay, as measured by medical record review</measure>
    <time_frame>Up to Day 90</time_frame>
    <description>Hospital length of stay in days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Shannon diversity, as measured by stool samples</measure>
    <time_frame>Baseline, Day 90</time_frame>
    <description>Stool samples assessed by 16s rRNA sequencing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in physical function, as measured by short physical performance battery (SPPB)</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>All the task points are added which make the SPPB score. The cut-point for the SPPB is a score of 10. The cumulative and sections scores are assessed individually and comprehensively. This assessment score will be used as a tool for evaluating lower extremity functioning in older persons.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical function, as measured by 30 second sit-stand</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>Subjects will sit in a chair with their arms crossed over their chest and rise to a standing position, then return to seated position. They will repeat this as many times as they can in 30 seconds.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in step count, as measured by activity tracker</measure>
    <time_frame>Continuous from baseline up to 3 years</time_frame>
    <description>Activity tracker tracks number of steps per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of falls, as assessed by Falls questionnaire</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>Participants will answer Yes/No to whether they have had any falls in the preceding 6 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical function, as measured by PROMIS Fatigue assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The questions are asked as interval format with &quot;0-Never&quot; through &quot;5-Always.&quot; Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical function, as measured by PROMIS Physical Function assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The questions are asked as interval format with &quot;0-Never&quot; through &quot;5-Always.&quot; Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive function, as measured by Montreal Cognitive Assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>This administered assessment is subdivided into visuospatial/executive (5pts), naming (3pts), memory (no points), attention(5pts), language(3pts), abstraction(2pts), delayed recall(5pts), and orientation(6pts). All the subdivided sections have as many questions as they have points. For analysis, the cut point is if the patient has less than 26 points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in cognitive function, as measured by PROMIS Cognitive Function assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The questions are asked as interval format with &quot;0-Never&quot; through &quot;5-Always.&quot; Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in depression score, as measured by PHQ-9 assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The PHQ-9 consists of 9 items, each of which is scored 0 to 3, giving a 0 to 27 severity score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target engagement (process of change), as assessed by Valuing Questionnaire (VQ)</measure>
    <time_frame>Baseline, every 2 weeks until Day 30, Day 60, Day 90</time_frame>
    <description>The VQ is a 10-item self-report questionnaire that assesses how closely a person is living in align with their values over the last week.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mental health, as measured by PC-PTSD/PCL-5 assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>PC-PTSD is a 5 item screen to identify patients with probable PTSD. If the patient screens positive, they then take the PCL-5. The PCL-5 is a 20 item screen to assess symptoms of PTSD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mental health, as measured by PROMIS Depression assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The questions are asked as interval format with &quot;0-Never&quot; through &quot;5-Always.&quot; Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mental health, as measured by PROMIS Anxiety assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The questions are asked as interval format with &quot;0-Never&quot; through &quot;5-Always.&quot; Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mental health, as measured by PROMIS Emotional Support assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The questions are asked as interval format with &quot;0-Never&quot; through &quot;5-Always.&quot; Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mental health, as measured by PROMIS Social Isolation assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The questions are asked as interval format with &quot;0-Never&quot; through &quot;5-Always.&quot; Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mental health, as measured by HHI-12 assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The HHI-12 is an adapted 12 question version of the Hearth Hope Scale that assesses a patient's sense of hope</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in mental health, as measured by Brief COPE assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>Scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in nutrition, as measured by albumin values</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>Albumin levels can be associated with a patient's nutritional health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in nutrition, as measured by body mass index (BMI)</measure>
    <time_frame>Continuous from baseline</time_frame>
    <description>BMI can be associated with a patient's nutritional health</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in nutrition, as measured by Perioperative Nutrition Screen (PONS)</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>PONS analyzes BMI, weight loss, and food intake to screen for preoperative nutrition risk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in nutrition, as measured by PG-SGA/Clinician SGA assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>Scores for each section can range from 0-4 depending on severity and nutritional impact. The sum of all scores provides the Total PG-SGA score, which can be used to indicate the need for intervention (Bauer et al., 2002)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in nutrition, as measured by ASA-24 assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>ASA-24 is a self-administered 24-hour diet recall</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in social well-being, as measured by CMS Social Determinants of Health (SDOH) assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>CMS SDOH is a 10 item survey that assesses 5 domains of social needs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in financial status, as measured by COST-FACIT assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>COST-FACIT is an 11-item questionnaire that assesses a patient's financial toxicity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in caregiver socioeconomic status, as measured by SES assessment</measure>
    <time_frame>Baseline, D180, Year 1, Year 2, and Year 3</time_frame>
    <description>Questionnaire to assess caregiver socioeconomic status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in financial status, as measured by financial assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>22-item questionnaire to assess how a patient's care as affected their finances</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in overall well-being, as measured by Fried Frailty assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The scores of all of the sections are added and if the patient has a score greater or equal to three this assessment deems that the patients is frail. If the patient has a score between 1-2 the patient is deemed pre-frail.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in overall well-being, as measured by OARS IADLs assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>OARS IADL is a 7 item assessment that asks what level of assistance is needed to do 7 different activities of daily living</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life, as measured by FACT-BMT assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>50 item assessment. Higher total and domain scores indicate greater quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in caregiver quality of life, as measured by FACT-GP assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>21 item assessment scored on a 5-point Likert scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life, as measured by EQ-5D-5L assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The 5D represents 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Five levels of severity are measured, as indicated by the &quot;5L,&quot; ranging from &quot;no problems&quot; to &quot;extreme problems.&quot; All scores are converted into a summary index.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life, as measured by Lorig Self-Efficacy assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The Self-Efficacy to Manage Chronic Disease Scale is made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in caregiver quality of life, as measured by Self-Efficacy and Preparedness for Caregivers assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>9-item questionnaire to assess preparedness for caregiving</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in overall well-being, as measured by PROMIS Global Health assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The questions are asked as interval format with &quot;0-Never&quot; through &quot;5-Always.&quot; Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in overall well-being, as measured by PROMIS Sleep assessment</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The questions are asked as interval format with &quot;0-Never&quot; through &quot;5-Always.&quot; Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in symptom severity, as measured by PRO-CTCAE core symptom assessment</measure>
    <time_frame>Weekly through Year 1</time_frame>
    <description>Assessing changes in severity of 23 core symptoms that are typically associated with HCT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in microbiome diversity, as measured by skin swabs</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>Skin swab samples batch sequenced and microbiome analyzed</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in biomarkers, as measured by blood samples</measure>
    <time_frame>Baseline, Day 14, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>Assays evaluating angiogenic, stromal, and inflammatory markers and markers of aging (the Pepper Panel) are used to assess inflammation and frailty.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in metabolomics, as measured by blood samples</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>Approximately 1ml of plasma from the EDTA tube will be used for metabolomics analysis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in flow cytometry, as measured by blood samples</measure>
    <time_frame>Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>Whole blood samples, will be analyzed and monitored for outcomes such as immune cell differentiation, immune response and development of GVHD. Flow cytometry will be performed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of the intervention, as assessed by the Acceptability survey</measure>
    <time_frame>Baseline, at each ACT session time point</time_frame>
    <description>6-item survey to assess patients' opinion on the ACT program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptability of the intervention, as assessed by exit interviews</measure>
    <time_frame>Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>Exit interviews to assess patients' opinion on the ACT program</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical outcomes, as assessed by adverse events reporting</measure>
    <time_frame>Continuous from baseline</time_frame>
    <description>Post-HCT clinical outcomes (i.e. GVHD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in physical function, as measured by 6 minute walk test</measure>
    <time_frame>Baseline, Day 30, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>The baseline for each patient is made through an algorithm that factors the patients age and gender. The patient's score is compared to what a person that is the patient's same age and gender would get. This comparison is then used as a tool to assess aerobic capacity or endurance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay, as measured by medical record review</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Hospital length of stay in days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Shannon diversity, as measured by stool samples</measure>
    <time_frame>Baseline, D0, D7, D14, D21, Day 30, Day 60, Day 180, Year 1, Year 2, and Year 3</time_frame>
    <description>Stool samples assessed by 16s rRNA sequencing</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Hematopoietic Steam Cell Transplantation (HCT)</condition>
  <arm_group>
    <arm_group_label>Hematopoietic Stem Cell Transplantation (HCT) Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 HCT patients at Duke</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregivers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 HCT patients caregivers at Duke</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Acceptance and Commitment Therapy (ACT)</intervention_name>
    <description>The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.</description>
    <arm_group_label>Caregivers</arm_group_label>
    <arm_group_label>Hematopoietic Stem Cell Transplantation (HCT) Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient:&#xD;
&#xD;
          -  Over the age of 18&#xD;
&#xD;
          -  Undergoing allogeneic HCT for any cancer or noncancer illness&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  Has a caregiver willing to participate&#xD;
&#xD;
        Caregiver:&#xD;
&#xD;
          -  Over the age of 18&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Under the age of 18&#xD;
&#xD;
          -  Non-English speaking&#xD;
&#xD;
          -  Has a caregiver unwilling to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Sung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lauren Hill</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>October 4, 2022</last_update_submitted>
  <last_update_submitted_qc>October 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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>June 30, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT04423939/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>May 19, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04423939
org study id: Pro00105683
nct id: NCT04423939
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a research study to develop and test a novel protocol to reduce physical and
      psychological vulnerabilities that contribute to treatment intolerance and treatment-related
      morbidity and mortality among hematopoietic stem cell transplant (HCT) patients. When the
      participant enrolls in this study, they will be asked to participate in acceptance and
      commitment therapy (ACT) as well as complete in-person physical function tests and a
      cognitive test. They will also receive training on how to use iOS devices (e.g. iPad, iPhone)
      and activity trackers (e.g. Apple Watch), which will be provided to them during the duration
      of study participation. The study team will ask you to complete multiple surveys about
      emotional and cognitive function, diet and social support, and ask the participant to provide
      feedback about the treatment (e.g., what they liked or did not like). The study team will
      also ask the participant to provide stool samples for analysis of the bacteria in intestines,
      skin surface swabs for analysis of the bacteria on skin and blood samples for analysis of
      biomarkers and metabolites. Biomarkers and metabolites are molecular and cellular parts that
      deal with genetic makeup, like DNA, RNA, protein, and/or other naturally occurring substances
      that may be associated with transplant outcomes. Participants can expect to be enrolled in
      this study for 3 years.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in physical function, as measured by 6 minute walk test
time frame: Baseline, Day 90
description: The baseline for each patient is made through an algorithm that factors the patients age and gender. The patient's score is compared to what a person that is the patient's same age and gender would get. This comparison is then used as a tool to assess aerobic capacity or endurance.
measure: Hospital length of stay, as measured by medical record review
time frame: Up to Day 90
description: Hospital length of stay in days
measure: Change in Shannon diversity, as measured by stool samples
time frame: Baseline, Day 90
description: Stool samples assessed by 16s rRNA sequencing
measure: Change in physical function, as measured by short physical performance battery (SPPB)
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: All the task points are added which make the SPPB score. The cut-point for the SPPB is a score of 10. The cumulative and sections scores are assessed individually and comprehensively. This assessment score will be used as a tool for evaluating lower extremity functioning in older persons.
measure: Change in physical function, as measured by 30 second sit-stand
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: Subjects will sit in a chair with their arms crossed over their chest and rise to a standing position, then return to seated position. They will repeat this as many times as they can in 30 seconds.
measure: Change in step count, as measured by activity tracker
time frame: Continuous from baseline up to 3 years
description: Activity tracker tracks number of steps per day
measure: Number of falls, as assessed by Falls questionnaire
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
measure: Change in physical function, as measured by PROMIS Fatigue assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
measure: Change in physical function, as measured by PROMIS Physical Function assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
measure: Change in cognitive function, as measured by Montreal Cognitive Assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: This administered assessment is subdivided into visuospatial/executive (5pts), naming (3pts), memory (no points), attention(5pts), language(3pts), abstraction(2pts), delayed recall(5pts), and orientation(6pts). All the subdivided sections have as many questions as they have points. For analysis, the cut point is if the patient has less than 26 points.
measure: Change in cognitive function, as measured by PROMIS Cognitive Function assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
measure: Change in depression score, as measured by PHQ-9 assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The PHQ-9 consists of 9 items, each of which is scored 0 to 3, giving a 0 to 27 severity score
measure: Target engagement (process of change), as assessed by Valuing Questionnaire (VQ)
time frame: Baseline, every 2 weeks until Day 30, Day 60, Day 90
description: The VQ is a 10-item self-report questionnaire that assesses how closely a person is living in align with their values over the last week.
measure: Change in mental health, as measured by PC-PTSD/PCL-5 assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: PC-PTSD is a 5 item screen to identify patients with probable PTSD. If the patient screens positive, they then take the PCL-5. The PCL-5 is a 20 item screen to assess symptoms of PTSD.
measure: Change in mental health, as measured by PROMIS Depression assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
measure: Change in mental health, as measured by PROMIS Anxiety assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
measure: Change in mental health, as measured by PROMIS Emotional Support assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
measure: Change in mental health, as measured by PROMIS Social Isolation assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
measure: Change in mental health, as measured by HHI-12 assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The HHI-12 is an adapted 12 question version of the Hearth Hope Scale that assesses a patient's sense of hope
measure: Change in mental health, as measured by Brief COPE assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: Scores are presented for three overarching coping styles as average scores (sum of item scores divided by number of items), indicating the degree to which the respondent has been engaging in that coping style.
measure: Change in nutrition, as measured by albumin values
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: Albumin levels can be associated with a patient's nutritional health
measure: Change in nutrition, as measured by body mass index (BMI)
time frame: Continuous from baseline
description: BMI can be associated with a patient's nutritional health
measure: Change in nutrition, as measured by Perioperative Nutrition Screen (PONS)
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: PONS analyzes BMI, weight loss, and food intake to screen for preoperative nutrition risk
measure: Change in nutrition, as measured by PG-SGA/Clinician SGA assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: Scores for each section can range from 0-4 depending on severity and nutritional impact. The sum of all scores provides the Total PG-SGA score, which can be used to indicate the need for intervention (Bauer et al., 2002)
measure: Change in nutrition, as measured by ASA-24 assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: ASA-24 is a self-administered 24-hour diet recall
measure: Change in social well-being, as measured by CMS Social Determinants of Health (SDOH) assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: CMS SDOH is a 10 item survey that assesses 5 domains of social needs
measure: Change in financial status, as measured by COST-FACIT assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: COST-FACIT is an 11-item questionnaire that assesses a patient's financial toxicity
measure: Change in caregiver socioeconomic status, as measured by SES assessment
time frame: Baseline, D180, Year 1, Year 2, and Year 3
description: Questionnaire to assess caregiver socioeconomic status
measure: Change in financial status, as measured by financial assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: 22-item questionnaire to assess how a patient's care as affected their finances
measure: Change in overall well-being, as measured by Fried Frailty assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The scores of all of the sections are added and if the patient has a score greater or equal to three this assessment deems that the patients is frail. If the patient has a score between 1-2 the patient is deemed pre-frail.
measure: Change in overall well-being, as measured by OARS IADLs assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: OARS IADL is a 7 item assessment that asks what level of assistance is needed to do 7 different activities of daily living
measure: Change in quality of life, as measured by FACT-BMT assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: 50 item assessment. Higher total and domain scores indicate greater quality of life.
measure: Change in caregiver quality of life, as measured by FACT-GP assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: 21 item assessment scored on a 5-point Likert scale
measure: Change in quality of life, as measured by EQ-5D-5L assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The 5D represents 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Five levels of severity are measured, as indicated by the "5L," ranging from "no problems" to "extreme problems." All scores are converted into a summary index.
measure: Change in quality of life, as measured by Lorig Self-Efficacy assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The Self-Efficacy to Manage Chronic Disease Scale is made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident).
measure: Change in caregiver quality of life, as measured by Self-Efficacy and Preparedness for Caregivers assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: 9-item questionnaire to assess preparedness for caregiving
measure: Change in overall well-being, as measured by PROMIS Global Health assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
measure: Change in overall well-being, as measured by PROMIS Sleep assessment
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: The questions are asked as interval format with "0-Never" through "5-Always." Each of the PRO instruments will be scored on the T-score metric, where 50 is the mean of a reference population and 10 is the standard deviation of that population.
measure: Change in symptom severity, as measured by PRO-CTCAE core symptom assessment
time frame: Weekly through Year 1
description: Assessing changes in severity of 23 core symptoms that are typically associated with HCT
measure: Change in microbiome diversity, as measured by skin swabs
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: Skin swab samples batch sequenced and microbiome analyzed
measure: Changes in biomarkers, as measured by blood samples
time frame: Baseline, Day 14, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: Assays evaluating angiogenic, stromal, and inflammatory markers and markers of aging (the Pepper Panel) are used to assess inflammation and frailty.
measure: Changes in metabolomics, as measured by blood samples
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: Approximately 1ml of plasma from the EDTA tube will be used for metabolomics analysis.
measure: Changes in flow cytometry, as measured by blood samples
time frame: Baseline, Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: Whole blood samples, will be analyzed and monitored for outcomes such as immune cell differentiation, immune response and development of GVHD. Flow cytometry will be performed.
measure: Acceptability of the intervention, as assessed by the Acceptability survey
time frame: Baseline, at each ACT session time point
description: 6-item survey to assess patients' opinion on the ACT program
measure: Acceptability of the intervention, as assessed by exit interviews
time frame: Day 30, Day 90, Day 180, Year 1, Year 2, and Year 3
description: Exit interviews to assess patients' opinion on the ACT program
measure: Clinical outcomes, as assessed by adverse events reporting
time frame: Continuous from baseline
description: Post-HCT clinical outcomes (i.e. GVHD)
measure: Change in physical function, as measured by 6 minute walk test
time frame: Baseline, Day 30, Day 180, Year 1, Year 2, and Year 3
description: The baseline for each patient is made through an algorithm that factors the patients age and gender. The patient's score is compared to what a person that is the patient's same age and gender would get. This comparison is then used as a tool to assess aerobic capacity or endurance.
measure: Hospital length of stay, as measured by medical record review
time frame: Up to 3 years
description: Hospital length of stay in days
measure: Change in Shannon diversity, as measured by stool samples
time frame: Baseline, D0, D7, D14, D21, Day 30, Day 60, Day 180, Year 1, Year 2, and Year 3
description: Stool samples assessed by 16s rRNA sequencing
arm group label: Hematopoietic Stem Cell Transplantation (HCT) Patients
arm group type: Experimental
description: 20 HCT patients at Duke
arm group label: Caregivers
arm group type: Experimental
description: 20 HCT patients caregivers at Duke
intervention type: Behavioral
intervention name: Acceptance and Commitment Therapy (ACT)
description: The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.
arm group label: Caregivers
arm group label: Hematopoietic Stem Cell Transplantation (HCT) Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Anthony Sung, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
submitted: May 19, 2023