<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/NCT02257853</url>
  </required_header>
  <id_info>
    <org_study_id>140201</org_study_id>
    <secondary_id>14-CC-0201</secondary_id>
    <nct_id>NCT02257853</nct_id>
  </id_info>
  <brief_title>Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients</brief_title>
  <official_title>A Randomized Controlled Trial to Determine the Effectiveness of a Stress Reduction Intervention in Caregivers of Allogeneic Hematopoietic Stem Cell Transplant (HSCT) Recipients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institutes of Health Clinical Center (CC)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Heart, Lung, and Blood Institute (NHLBI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>National Institutes of Health Clinical Center (CC)</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>
      Background:&#xD;
&#xD;
      - People who have an allogeneic hematopoietic stem cell transplant (HSCT) need help as they&#xD;
      recover. Being a caregiver can be stressful to the body and mind. Researchers want to find&#xD;
      ways to reduce this stress.&#xD;
&#xD;
      Objective:&#xD;
&#xD;
      - To see how a stress reduction intervention affects the stress levels and health of an HSCT&#xD;
      caregiver.&#xD;
&#xD;
      Eligibility:&#xD;
&#xD;
      - Adults age 18 and older who plan to be an active caregiver for a person having their first&#xD;
      allogeneic HSCT at the NIH Clinical Center. An active caregiver is someone who will be caring&#xD;
      for the person from just before admission for the HSCT until at least 6 weeks after.&#xD;
&#xD;
      Design:&#xD;
&#xD;
        -  Participants will be put in either the intervention group or the control group.&#xD;
&#xD;
        -  All participants will get the usual caregiver education given to all patients and&#xD;
           caregivers having a stem cell transplant at the NIH Clinical Center.&#xD;
&#xD;
        -  All participants will have 2 study visits. They will give blood samples. They will have&#xD;
           health assessments and brief physical exams. They will fill out study questionnaires and&#xD;
           have an exit interview.&#xD;
&#xD;
        -  The intervention group will get an MP3 player. It will have an audio file with a stress&#xD;
           reduction intervention on it. Participants will do this intervention daily. It takes 20&#xD;
           minutes. They will do gentle stretches and breathing exercises. They will get a diary to&#xD;
           track their practice.&#xD;
&#xD;
        -  The intervention group also will have follow-up phone calls 2 and 4 weeks after their&#xD;
           first clinic visit.&#xD;
&#xD;
        -  The person getting the HSCT will not be actively involved in the study.&#xD;
&#xD;
        -  The study will last about 2 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Millions of Americans provide unpaid care for aging or ill family members and friends.&#xD;
      Caregiving for an individual with cancer who is undergoing stem cell transplantation is&#xD;
      particularly stressful. The stress of caregiving is associated with many disorders, including&#xD;
      sleep disturbances, depression, and anxiety. Although there is good evidence that cancer&#xD;
      caregivers experience high levels of stress and stress-related symptoms, few interventions&#xD;
      studies have been explored to address this concern in this population.&#xD;
&#xD;
      Stress reduction techniques are important skills for individuals to cope with the stress of&#xD;
      cancer caregiving. Mindfulness techniques such as yoga and meditation reduce levels of stress&#xD;
      and stress-related symptoms in caregivers. However, many caregivers are reluctant to take&#xD;
      time away from the patient to attend to their own health and well-being. Few studies have&#xD;
      explored yoga-based stress reduction interventions that can be performed at home or at the&#xD;
      patient s bedside.&#xD;
&#xD;
      Based upon our past research examining stress and stress-related symptoms in stem cell&#xD;
      transplant caregivers, this study is designed to determine preliminary effectiveness of a&#xD;
      yoga-based stress reduction intervention in reducing levels of stress in caregivers during&#xD;
      allogeneic hematopoietic stem cell transplant (HSCT). In addition, this study will&#xD;
      explorefactors associated with change in caregiver stress and symptoms such as demographics,&#xD;
      clinical variables, cardiometabolic and inflammatory markers, and health behaviors.&#xD;
&#xD;
      This study will use a prospective randomized control group design to examine the effects of a&#xD;
      six-week yoga-based stress reduction intervention on perceived stress in caregivers of&#xD;
      allogeneic HSCT patients. Subjects will be accrued to this protocol if they are a caregiver&#xD;
      of an individual undergoing allogeneic HSCT at the Clinical Center, NIH, are greater than or&#xD;
      equal to 18 years old, able to read English, stand and sit unassisted, raise arms over head&#xD;
      without pain, and able to comprehend the investigational nature of the study. A sample of at&#xD;
      least 78 caregivers is needed to adequately evaluate the effectiveness of the intervention.&#xD;
&#xD;
      All caregivers will attend the usual care group education provided at the Clinical Center for&#xD;
      transplant caregivers. Caregivers randomized to the intervention group will be scheduled for&#xD;
      one session with study personnel to receive a 20 minute audio file of gentle chair yoga poses&#xD;
      and guided breath awareness, as well as instructions for performing them, and they will be&#xD;
      asked to practice daily. Data, in the form of web-based questionnaires, as well as a physical&#xD;
      assessment, demographic interview and blood work will be collected from all study&#xD;
      participants at baseline (at or near the time of HSCT) and again at the end of the six-week&#xD;
      intervention. There will be no long-term follow-up after the intervention period.&#xD;
      Questionnaires include: Caregiver Reaction Assessment, Health-Promoting Lifestyle Profile II,&#xD;
      Pittsburgh Sleep Quality Index, Freiburg Mindfulness Scale, PROMIS measures of anxiety,&#xD;
      applied cognition, depression, positive affect and well-being, Multidimensional Fatigue&#xD;
      Symptom Inventory-Short Form and NIH Toolbox measures of loneliness, self-efficacy, and&#xD;
      perceived stress. Subjects will participate in an exit interview at the end of the study and&#xD;
      the interventionist will complete a log, based on subject diaries, that tracks subject&#xD;
      practice, and discrepancy between planned and actual session date and time. Quantitative&#xD;
      analysis techniques will be used in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2015</start_date>
  <completion_date type="Actual">February 7, 2019</completion_date>
  <primary_completion_date type="Actual">November 8, 2018</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Perceived stress</measure>
    <time_frame>Pre &amp;amp; 6 Weeks Post</time_frame>
    <description>To examine whether HSCT caregivers participating in a stress reduction intervention demonstrate improvement in certain individual factors (self-efficacy, burden, and mindfulness), psychosocial factors (stress, anxiety, depression, loneliness, positive affect and well-being), behaviors (health behaviors) and symptoms (sleep, fatigue, depression, and cognitive impairment) compared with HSCT caregivers in the control group.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiometabolic factors</measure>
    <time_frame>Pre &amp;amp; 6 weeks post</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory cytokines</measure>
    <time_frame>Pre &amp;amp; 6 Weeks Post</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-reported symptoms</measure>
    <time_frame>Pre &amp;amp; 6 weeks post</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Stress, Psychological</condition>
  <condition>Caregivers</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Receives stress reduction intervention introduction with daily practice</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Stress reduction intervention</intervention_name>
    <description>Gentle chair yoga and breath work</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  INCLUSION CRITERIA:&#xD;
&#xD;
          -  Age greater than or equal to 18 years old&#xD;
&#xD;
          -  Ability to comprehend the investigational nature of the study&#xD;
&#xD;
          -  Able to read and speak English&#xD;
&#xD;
          -  Agrees to participate in the study&#xD;
&#xD;
          -  Able to lift arms over head without pain&#xD;
&#xD;
          -  Able to sit and stand from a seated position unassisted&#xD;
&#xD;
          -  Intends to serve as an active caregiver* for a patient undergoing their 1st allogeneic&#xD;
             HSCT at the NIH Clinical Center&#xD;
&#xD;
        EXCLUSION CRITERIA:&#xD;
&#xD;
          -  Age less than or equal to 18 years old&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Inability to comprehend investigational nature of study&#xD;
&#xD;
          -  Inability to provide informed consent&#xD;
&#xD;
          -  Unable to read and speak English&#xD;
&#xD;
          -  Does not agree to participate in study or follow study design&#xD;
&#xD;
          -  Serving as a paid caregiver for any individual&#xD;
&#xD;
          -  Regular practitioner of yoga, meditation or other mind-body practice (definition:&#xD;
             taking classes or practicing at least weekly for at least 2 of the past 6 months).&#xD;
&#xD;
          -  Physical function limitations that would interfere with intervention&#xD;
&#xD;
        Caregiver participants will be excluded from the biomarker analysis if they have had:&#xD;
&#xD;
          -  Glucocorticosteroid treatment in the last 2 months&#xD;
&#xD;
          -  Have a recent (within the last 2 months) acute illness or injury&#xD;
&#xD;
          -  Have served as a stem cell transplant donor or have taken filgastrim&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lena Jumin Lee (Park), Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Institutes of Health Clinical Center (CC)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Institutes of Health Clinical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20892</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2014-CC-0201.html</url>
    <description>NIH Clinical Center Detailed Web Page</description>
  </link>
  <verification_date>March 9, 2023</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Caregiver Stress</keyword>
  <keyword>Cancer Caregivers</keyword>
  <keyword>Yoga-Based Stress Reduction Intervention</keyword>
  <keyword>HSCT Caregivers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <!-- 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/NCT02257853
org study id: 140201
secondary id: 14-CC-0201
nct id: NCT02257853
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
Background:

      - People who have an allogeneic hematopoietic stem cell transplant (HSCT) need help as they
      recover. Being a caregiver can be stressful to the body and mind. Researchers want to find
      ways to reduce this stress.

      Objective:

      - To see how a stress reduction intervention affects the stress levels and health of an HSCT
      caregiver.

      Eligibility:

      - Adults age 18 and older who plan to be an active caregiver for a person having their first
      allogeneic HSCT at the NIH Clinical Center. An active caregiver is someone who will be caring
      for the person from just before admission for the HSCT until at least 6 weeks after.

      Design:

        -  Participants will be put in either the intervention group or the control group.

        -  All participants will get the usual caregiver education given to all patients and
           caregivers having a stem cell transplant at the NIH Clinical Center.

        -  All participants will have 2 study visits. They will give blood samples. They will have
           health assessments and brief physical exams. They will fill out study questionnaires and
           have an exit interview.

        -  The intervention group will get an MP3 player. It will have an audio file with a stress
           reduction intervention on it. Participants will do this intervention daily. It takes 20
           minutes. They will do gentle stretches and breathing exercises. They will get a diary to
           track their practice.

        -  The intervention group also will have follow-up phone calls 2 and 4 weeks after their
           first clinic visit.

        -  The person getting the HSCT will not be actively involved in the study.

        -  The study will last about 2 months.
Millions of Americans provide unpaid care for aging or ill family members and friends.
      Caregiving for an individual with cancer who is undergoing stem cell transplantation is
      particularly stressful. The stress of caregiving is associated with many disorders, including
      sleep disturbances, depression, and anxiety. Although there is good evidence that cancer
      caregivers experience high levels of stress and stress-related symptoms, few interventions
      studies have been explored to address this concern in this population.

      Stress reduction techniques are important skills for individuals to cope with the stress of
      cancer caregiving. Mindfulness techniques such as yoga and meditation reduce levels of stress
      and stress-related symptoms in caregivers. However, many caregivers are reluctant to take
      time away from the patient to attend to their own health and well-being. Few studies have
      explored yoga-based stress reduction interventions that can be performed at home or at the
      patient s bedside.

      Based upon our past research examining stress and stress-related symptoms in stem cell
      transplant caregivers, this study is designed to determine preliminary effectiveness of a
      yoga-based stress reduction intervention in reducing levels of stress in caregivers during
      allogeneic hematopoietic stem cell transplant (HSCT). In addition, this study will
      explorefactors associated with change in caregiver stress and symptoms such as demographics,
      clinical variables, cardiometabolic and inflammatory markers, and health behaviors.

      This study will use a prospective randomized control group design to examine the effects of a
      six-week yoga-based stress reduction intervention on perceived stress in caregivers of
      allogeneic HSCT patients. Subjects will be accrued to this protocol if they are a caregiver
      of an individual undergoing allogeneic HSCT at the Clinical Center, NIH, are greater than or
      equal to 18 years old, able to read English, stand and sit unassisted, raise arms over head
      without pain, and able to comprehend the investigational nature of the study. A sample of at
      least 78 caregivers is needed to adequately evaluate the effectiveness of the intervention.

      All caregivers will attend the usual care group education provided at the Clinical Center for
      transplant caregivers. Caregivers randomized to the intervention group will be scheduled for
      one session with study personnel to receive a 20 minute audio file of gentle chair yoga poses
      and guided breath awareness, as well as instructions for performing them, and they will be
      asked to practice daily. Data, in the form of web-based questionnaires, as well as a physical
      assessment, demographic interview and blood work will be collected from all study
      participants at baseline (at or near the time of HSCT) and again at the end of the six-week
      intervention. There will be no long-term follow-up after the intervention period.
      Questionnaires include: Caregiver Reaction Assessment, Health-Promoting Lifestyle Profile II,
      Pittsburgh Sleep Quality Index, Freiburg Mindfulness Scale, PROMIS measures of anxiety,
      applied cognition, depression, positive affect and well-being, Multidimensional Fatigue
      Symptom Inventory-Short Form and NIH Toolbox measures of loneliness, self-efficacy, and
      perceived stress. Subjects will participate in an exit interview at the end of the study and
      the interventionist will complete a log, based on subject diaries, that tracks subject
      practice, and discrepancy between planned and actual session date and time. Quantitative
      analysis techniques will be used in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Perceived stress
time frame: Pre &amp; 6 Weeks Post
description: To examine whether HSCT caregivers participating in a stress reduction intervention demonstrate improvement in certain individual factors (self-efficacy, burden, and mindfulness), psychosocial factors (stress, anxiety, depression, loneliness, positive affect and well-being), behaviors (health behaviors) and symptoms (sleep, fatigue, depression, and cognitive impairment) compared with HSCT caregivers in the control group.
measure: Cardiometabolic factors
time frame: Pre &amp; 6 weeks post
measure: Inflammatory cytokines
time frame: Pre &amp; 6 Weeks Post
measure: Self-reported symptoms
time frame: Pre &amp; 6 weeks post
arm group label: Control Group
arm group type: No Intervention
description: No intervention group
arm group label: Intervention
arm group type: Experimental
description: Receives stress reduction intervention introduction with daily practice
intervention type: Other
intervention name: Stress reduction intervention
description: Gentle chair yoga and breath work
arm group label: Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lena Jumin Lee (Park), Ph.D.
role: Principal Investigator
affiliation: National Institutes of Health Clinical Center (CC)
facility: 
country: United States
url: https://clinicalstudies.info.nih.gov/cgi/detail.cgi?B_2014-CC-0201.html
description: NIH Clinical Center Detailed Web Page
responsible party type: Sponsor
mesh term: Stress, Psychological