<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/NCT02194413</url>
  </required_header>
  <id_info>
    <org_study_id>201111724</org_study_id>
    <secondary_id>P30CA086862</secondary_id>
    <nct_id>NCT02194413</nct_id>
  </id_info>
  <brief_title>Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant</brief_title>
  <official_title>Effects of Healing Touch on Patients Undergoing Hematopoietic Stem Cell Transplant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized pilot clinical trial studies healing touch or usual care in improving quality&#xD;
      of life in patients undergoing stem cell transplant. Healing touch may improve the quality of&#xD;
      life of patients undergoing stem cell transplant.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary Objectives:&#xD;
&#xD;
      I. To estimate the effects of healing touch (HT) vs usual care in the following clinical&#xD;
      outcomes of stem cell transplant (SCT) patients; length of hospital stay, days to&#xD;
      engraftment, and number of hospital readmissions during 100 days post-transplant.&#xD;
&#xD;
      II. To estimate changes in quality of life (QoL) which occur during hospitalization of SCT&#xD;
      patients who receive HT vs. usual care.&#xD;
&#xD;
      III. To examine differences in effects of HT vs. usual care (UC) in patients receiving&#xD;
      related allogeneic (Allo) transplant compared to those receiving autologous (Auto)&#xD;
      transplant.&#xD;
&#xD;
      OUTLINE: Patients are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Patients receive daily HT sessions comprising pain drain, chakra connection, magnetic&#xD;
      clearing, and mind clearing over 30 minutes from day 1 until 2 days before discharge from the&#xD;
      hospital.&#xD;
&#xD;
      ARM II: Patients receive routine nursing care from doctors and nurses from day 1 until 2 days&#xD;
      before discharge from the hospital.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for 100 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2012</start_date>
  <completion_date type="Actual">January 18, 2017</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater</measure>
    <time_frame>Up to 100 days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in QoL (POMS-SF, FACT-BMT, CES-D)</measure>
    <time_frame>Baseline up to 100 days</time_frame>
    <description>Changes in levels of QoL measures before and after hospitalization will be compared using the paired t-test or the nonparametric paired sign test, if the assumption of normality is substantially violated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of hospital readmissions</measure>
    <time_frame>Up to 100 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Anxiety Disorder</condition>
  <condition>Fatigue</condition>
  <condition>Hematopoietic/Lymphoid Cancer</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Arm 1 (healing touch)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive daily HT sessions comprising pain drain, chakra connection, magnetic clearing, and mind clearing over 30 minutes from day 1 until 2 days before discharge from the hospital (therapeutic touch).&#xD;
Interventions: therapeutic touch, quality-of-life assessment, and questionnaire administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm II (usual care)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receive routine nursing care from doctors and nurses from day 1 until 2 days before discharge from the hospital.&#xD;
Interventions: quality-of-life assessment, and questionnaire administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>therapeutic touch</intervention_name>
    <description>receiving healing touch</description>
    <arm_group_label>Arm 1 (healing touch)</arm_group_label>
    <other_name>healing touch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>quality-of-life assessment</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm 1 (healing touch)</arm_group_label>
    <arm_group_label>Arm II (usual care)</arm_group_label>
    <other_name>quality of life assessment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>questionnaire administration</intervention_name>
    <description>Ancillary studies</description>
    <arm_group_label>Arm 1 (healing touch)</arm_group_label>
    <arm_group_label>Arm II (usual care)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Currently undergoing autologous (auto) or related allogeneic (related allo) stem cell&#xD;
             transplantation&#xD;
&#xD;
          -  Admitted to the University (U) Adult Blood and Bone Marrow Transplant Unit (UIBMTU) of&#xD;
             the University of Iowa Hospitals and Clinic&#xD;
&#xD;
          -  Ability to provide written informed consent obtained prior to participation in the&#xD;
             study and able to complete questionnaires&#xD;
&#xD;
          -  Pregnant woman who are eligible for stem cell transplant are included in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with any significant history of non-compliance to medical regimens, with&#xD;
             inability to grant a reliable informed consent or unable to complete questionnaires&#xD;
&#xD;
          -  Patients with evidence of a significant psychiatric disorder by history that would&#xD;
             prevent completion of the study will not be allowed to participate, i.e.,&#xD;
             schizophrenia, anxiety disorder, major depressive disorder and bipolar disorder&#xD;
&#xD;
          -  Diagnosis of dementia or other disease affecting cognitive function&#xD;
&#xD;
          -  Nursing women are excluded&#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>Susan K Lutgendorf, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Iowa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>July 16, 2014</study_first_submitted>
  <study_first_submitted_qc>July 17, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>January 30, 2017</last_update_submitted>
  <last_update_submitted_qc>January 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Susan Lutgendorf</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</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/NCT02194413
org study id: 201111724
secondary id: P30CA086862
nct id: NCT02194413
lead sponsor: 
collaborator: 
has dmc: Yes
This randomized pilot clinical trial studies healing touch or usual care in improving quality
      of life in patients undergoing stem cell transplant. Healing touch may improve the quality of
      life of patients undergoing stem cell transplant.
Primary Objectives:

      I. To estimate the effects of healing touch (HT) vs usual care in the following clinical
      outcomes of stem cell transplant (SCT) patients; length of hospital stay, days to
      engraftment, and number of hospital readmissions during 100 days post-transplant.

      II. To estimate changes in quality of life (QoL) which occur during hospitalization of SCT
      patients who receive HT vs. usual care.

      III. To examine differences in effects of HT vs. usual care (UC) in patients receiving
      related allogeneic (Allo) transplant compared to those receiving autologous (Auto)
      transplant.

      OUTLINE: Patients are randomized to 1 of 2 arms.

      ARM I: Patients receive daily HT sessions comprising pain drain, chakra connection, magnetic
      clearing, and mind clearing over 30 minutes from day 1 until 2 days before discharge from the
      hospital.

      ARM II: Patients receive routine nursing care from doctors and nurses from day 1 until 2 days
      before discharge from the hospital.

      After completion of study treatment, patients are followed up for 100 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Length of hospital stay, Days to engraftment defined as absolute neutrophil count (ANC: segs + bands) greater
time frame: Up to 100 days
measure: Changes in QoL (POMS-SF, FACT-BMT, CES-D)
time frame: Baseline up to 100 days
description: Changes in levels of QoL measures before and after hospitalization will be compared using the paired t-test or the nonparametric paired sign test, if the assumption of normality is substantially violated.
measure: Number of hospital readmissions
time frame: Up to 100 days
arm group label: Arm 1 (healing touch)
arm group type: Experimental
description: Patients receive daily HT sessions comprising pain drain, chakra connection, magnetic clearing, and mind clearing over 30 minutes from day 1 until 2 days before discharge from the hospital (therapeutic touch).
Interventions: therapeutic touch, quality-of-life assessment, and questionnaire administration
arm group label: Arm II (usual care)
arm group type: Active Comparator
description: Patients receive routine nursing care from doctors and nurses from day 1 until 2 days before discharge from the hospital.
Interventions: quality-of-life assessment, and questionnaire administration
intervention type: Procedure
intervention name: therapeutic touch
description: receiving healing touch
arm group label: Arm 1 (healing touch)
other name: healing touch
intervention type: Other
intervention name: quality-of-life assessment
description: Ancillary studies
arm group label: Arm 1 (healing touch)
arm group label: Arm II (usual care)
other name: quality of life assessment
intervention type: Other
intervention name: questionnaire administration
description: Ancillary studies
arm group label: Arm 1 (healing touch)
arm group label: Arm II (usual care)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Susan K Lutgendorf, PhD
role: Principal Investigator
affiliation: University of Iowa
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Iowa
investigator full name: Susan Lutgendorf
investigator title: Professor
mesh term: Anxiety Disorders
sharing ipd: No