<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/NCT03823651</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00092963</org_study_id>
    <nct_id>NCT03823651</nct_id>
  </id_info>
  <brief_title>A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)</brief_title>
  <official_title>A Research Program Targeting Pre- and Peri-transplant Optimization Program (R-PPOP)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the feasibility and outcomes of a research pre- and&#xD;
      peri-transplant optimization program (R-PPOP) to improve multiple domains of health including&#xD;
      physical function, cognitive function, mental health, and diet and nutrition for patients&#xD;
      planning to undergo or undergoing hematopoietic stem cell transplantation (HCT).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 27, 2019</start_date>
  <completion_date type="Anticipated">May 1, 2024</completion_date>
  <primary_completion_date type="Actual">October 27, 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects who complete at least half of their high intensity interval training sessions</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physical activity as measured by Cardiopulmonary exercise testing (CPET)</measure>
    <time_frame>day 180</time_frame>
    <description>CPET is scored by measuring changes in V02 max</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Physical function as assessed by PROMIS physical function questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment is scored from 5 (least severe) to 1 (most severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cognitive function as assessed by PROMIS cognitive questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment is scored from 5 (least severe) to 1 (most severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental health as assessed by PROMIS depression questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment is scored from 1 (least severe) to 5 (most severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nutrition as assessed by the 24 hour food recall survey</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet as assessed by the TRU-BMT digital application</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Diet as assessed by the food group tracking digital application</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social support as assessed by the PROMIS social isolation questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment is scored from 1 (least severe) to 5 (most severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver support as assessed by the caregiver strain index questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring Changes in the skin flora (microbiome) in transplant patients</measure>
    <time_frame>baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring biomarkers of inflammation/frailty in blood plasma samples</measure>
    <time_frame>1 year</time_frame>
    <description>Biomarker panel to be analyzed: CRP, Eotaxin, Eotaxin-3, FGF (basic), Flt-1/VEGFR-1, GM-CSF, ICAM-1, IFN-γ, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17B, IL-17C, IL-17D, IL-1RA, IL-1α, IL-1β, IL-2, IL-21, IL-22, IL-23, IL-27, IL-3, IL-31, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-9, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, MIP-3α, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, TSLP, VCAM-1, VEGF-A, VEGF-C, VEGF-D</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fecal samples as measured by 16s rRNA sequencing in transplant patients</measure>
    <time_frame>baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bacterial infections</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of viral infections</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of fungal infections</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of overall infections</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of hospital admission/re-admission</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of intensive care unit admission/re-admission</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intensive care unit length of stay</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Graft versus host disease (GVHD)</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transplant length of stay</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Return to work as assessed by the Work Assessment</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessing falls</measure>
    <time_frame>1 year</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>Delirium as measured by the DOS assessment</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life as assessed by the FACT-BMT questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>Scored from 0 (least severe) to 4 (most severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Caregiver quality of life as assessed by the Caregiver Strain questionnaire</measure>
    <time_frame>1 year</time_frame>
    <description>Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in fecal samples as measured by 16s rRNA sequencing in caregivers</measure>
    <time_frame>baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measuring Changes in the skin flora (microbiome) in caregivers</measure>
    <time_frame>baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Hematologic Malignancy</condition>
  <arm_group>
    <arm_group_label>Patient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caregiver</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Interval training</intervention_name>
    <description>Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise.</description>
    <arm_group_label>Patient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychiatric consult</intervention_name>
    <description>Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.</description>
    <arm_group_label>Caregiver</arm_group_label>
    <arm_group_label>Patient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Nutrition/diet evaluation</intervention_name>
    <description>PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month</description>
    <arm_group_label>Caregiver</arm_group_label>
    <arm_group_label>Patient</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Referral to Social Worker</intervention_name>
    <description>Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up</description>
    <arm_group_label>Caregiver</arm_group_label>
    <arm_group_label>Patient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patient Inclusion Criteria:&#xD;
&#xD;
          -  Plan to undergo an allogeneic hematopoietic stem cell transplant for any cancer or&#xD;
             non-cancer illness within the next 6 months&#xD;
&#xD;
          -  Age 18-80 years&#xD;
&#xD;
        Patient Exclusion Criteria:&#xD;
&#xD;
          -  Both patient and caregiver are unable to read and follow directions in English (ok if&#xD;
             only patient cannot read and follow directions in English as caregiver will be able to&#xD;
             help).&#xD;
&#xD;
          -  Any absolute contraindications to exercise:&#xD;
&#xD;
          -  recent (&lt; 6 months) acute cardiac event;&#xD;
&#xD;
          -  unstable angina;&#xD;
&#xD;
          -  uncontrolled dysrhythmias causing symptoms or hemodynamic compromise;&#xD;
&#xD;
          -  symptomatic aortic stenosis;&#xD;
&#xD;
          -  uncontrolled symptomatic heart failure;&#xD;
&#xD;
          -  acute pulmonary embolus;&#xD;
&#xD;
          -  acute myocarditis or pericarditis;&#xD;
&#xD;
          -  suspected or known dissecting aneurism; or&#xD;
&#xD;
          -  coronary artery disease.&#xD;
&#xD;
          -  Functional impairment resulting in inability to exercise&#xD;
&#xD;
        Caregiver inclusion criteria&#xD;
&#xD;
          -  Identified by patient as their primary caregiver&#xD;
&#xD;
          -  Age 18-80 years&#xD;
&#xD;
        Caregiver exclusion criteria&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anthony Sung, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Adult Bone Marrow Transplant Clinic</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>January 28, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>December 16, 2022</last_update_submitted>
  <last_update_submitted_qc>December 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  </patient_data>
  <!-- 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/NCT03823651
org study id: Pro00092963
nct id: NCT03823651
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the feasibility and outcomes of a research pre- and
      peri-transplant optimization program (R-PPOP) to improve multiple domains of health including
      physical function, cognitive function, mental health, and diet and nutrition for patients
      planning to undergo or undergoing hematopoietic stem cell transplantation (HCT).
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of subjects who complete at least half of their high intensity interval training sessions
time frame: 6 months
measure: Physical activity as measured by Cardiopulmonary exercise testing (CPET)
time frame: day 180
description: CPET is scored by measuring changes in V02 max
measure: Physical function as assessed by PROMIS physical function questionnaire
time frame: 1 year
description: Assessment is scored from 5 (least severe) to 1 (most severe)
measure: Cognitive function as assessed by PROMIS cognitive questionnaire
time frame: 1 year
description: Assessment is scored from 5 (least severe) to 1 (most severe)
measure: Mental health as assessed by PROMIS depression questionnaire
time frame: 1 year
description: Assessment is scored from 1 (least severe) to 5 (most severe)
measure: Nutrition as assessed by the 24 hour food recall survey
time frame: 30 days
measure: Diet as assessed by the TRU-BMT digital application
time frame: 30 days
measure: Diet as assessed by the food group tracking digital application
time frame: 30 days
measure: Social support as assessed by the PROMIS social isolation questionnaire
time frame: 1 year
description: Assessment is scored from 1 (least severe) to 5 (most severe)
measure: Caregiver support as assessed by the caregiver strain index questionnaire
time frame: 1 year
description: Assessment is scored as 0 (never/least severe), 1 (sometimes), 2 (on a regular basis/most severe)
measure: Measuring Changes in the skin flora (microbiome) in transplant patients
time frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
measure: Measuring biomarkers of inflammation/frailty in blood plasma samples
time frame: 1 year
description: Biomarker panel to be analyzed: CRP, Eotaxin, Eotaxin-3, FGF (basic), Flt-1/VEGFR-1, GM-CSF, ICAM-1, IFN-γ, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17B, IL-17C, IL-17D, IL-1RA, IL-1α, IL-1β, IL-2, IL-21, IL-22, IL-23, IL-27, IL-3, IL-31, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-9, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, MIP-3α, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, TSLP, VCAM-1, VEGF-A, VEGF-C, VEGF-D
measure: Changes in fecal samples as measured by 16s rRNA sequencing in transplant patients
time frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365, 730
measure: Overall survival
time frame: 1 year
measure: Disease-free survival
time frame: 1 year
measure: Rate of bacterial infections
time frame: 1 year
measure: Rate of viral infections
time frame: 1 year
measure: Rate of fungal infections
time frame: 1 year
measure: Rate of overall infections
time frame: 1 year
measure: Rate of hospital admission/re-admission
time frame: 1 year
measure: Rate of intensive care unit admission/re-admission
time frame: 1 year
measure: Hospital length of stay
time frame: 1 year
measure: Intensive care unit length of stay
time frame: 1 year
measure: Graft versus host disease (GVHD)
time frame: 1 year
measure: Transplant length of stay
time frame: 1 year
measure: Return to work as assessed by the Work Assessment
time frame: 1 year
measure: Assessing falls
time frame: 1 year
description: Participants will answer Yes/No to whether they have had any falls in the preceding 6 months
measure: Delirium as measured by the DOS assessment
time frame: 1 year
measure: Quality of life as assessed by the FACT-BMT questionnaire
time frame: 1 year
description: Scored from 0 (least severe) to 4 (most severe)
measure: Caregiver quality of life as assessed by the Caregiver Strain questionnaire
time frame: 1 year
description: Scored as 0 (No, least severe), 1 (Yes, sometimes) and 2 (Yes, on a regular basis, most severe)
measure: Changes in fecal samples as measured by 16s rRNA sequencing in caregivers
time frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
measure: Measuring Changes in the skin flora (microbiome) in caregivers
time frame: baseline, sign off, day 0 (transplant), 7, 14, 21, 30, 60, 90,180, 365
arm group label: Patient
arm group type: Experimental
description: These are patients undergoing hematopoetic stem cell transplant. Patients will complete Interval training, undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
arm group label: Caregiver
arm group type: Experimental
description: These are the assigned caregivers for transplant patients. Caregivers will undergo psychiatric consult, nutrition/diet evaluation and referral to social worker.
intervention type: Behavioral
intervention name: Interval training
description: Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise.
arm group label: Patient
intervention type: Behavioral
intervention name: Psychiatric consult
description: Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
arm group label: Caregiver
arm group label: Patient
intervention type: Behavioral
intervention name: Nutrition/diet evaluation
description: PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
arm group label: Caregiver
arm group label: Patient
intervention type: Behavioral
intervention name: Referral to Social Worker
description: Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
arm group label: Caregiver
arm group label: Patient
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Anthony Sung, MD
role: Principal Investigator
affiliation: Duke Health
facility: 
country: United States
responsible party type: Sponsor
mesh term: Hematologic Neoplasms
sharing ipd: No