xml: <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/NCT05979610</url>
    </required_header>
    <id_info>
      <org_study_id>HCI158391</org_study_id>
      <nct_id>NCT05979610</nct_id>
    </id_info>
    <brief_title>Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies</brief_title>
    <acronym>Reiki-Brachy</acronym>
    <official_title>Reiki-Brachy: An Interventional Treatment Trial Using Reiki Therapy to Improve Symptoms Associated With Brachytherapy in Patients With Gynecological Malignancies</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Utah</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Utah</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 goal of this open label, randomized, controlled clinical trial is to assess the benefits&#xD;
        of providing Reiki therapy to subjects receiving their first brachytherapy treatment for&#xD;
        gynecological malignancies.&#xD;
  &#xD;
        Participants will either receive a session of Reiki therapy or usual care during the standard&#xD;
        wait time between the placement of the brachytherapy device and brachytherapy treatment.&#xD;
        Questionnaires will be administered at various time points on the day of the participant's&#xD;
        first brachytherapy treatment as well as at the three month follow-up time point.&#xD;
  &#xD;
        Researchers will compare the intervention (Reiki therapy) and control (usual care) groups to&#xD;
        assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and&#xD;
        physiological measurements.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 30, 2023</start_date>
    <completion_date type="Anticipated">April 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">February 1, 2026</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>
      <intervention_model_description>Subjects who meet all criteria for enrollment will be randomly assigned to receive Reiki therapy (Arm 1) or usual care (Arm 2) using block randomization. Subjects will be randomized through the OnCore system in a 1:1 ratio to Arm 1 or Arm 2 and stratified by treatment type (multichannel vaginal cylinder (MCVC) and vaginal cylinder vs. all other treatment modalities). Randomization will not be blinded.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the 6-item Spielberger State Anxiety Scale.</measure>
      <time_frame>4 months</time_frame>
      <description>To assess the impact of Reiki therapy on anxiety in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.&#xD;
  The 6-item Spielberger State Anxiety Scale is a validated shortened version of the Spielberger State-Trait Anxiety Inventory (STAI) used to measure state anxiety. The scale utilizes a Likert scale with four response categories assigned numerical values from 1-4 (&quot;not at all,&quot;&quot;somewhat,&quot;&quot;moderately,&quot; and &quot;very much&quot;).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Comparison between the treatment groups of the change in pain from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.</measure>
      <time_frame>4 months</time_frame>
      <description>To assess the impact of Reiki therapy on pain in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.&#xD;
  The Visual Analogue Scale (VAS) uses an 11-point scale ranging from 0 (no symptom) to 10 (worst possible symptom). Using the pain-VAS scoring system, 0 is considered no pain, 1 - 3 is considered mild, 4 - 6 is moderate to severe, 7 - 9 is very severe and 10 is categorized as worst possible pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison between the treatment groups of the change in anxiety from Assessment 2 to Assessment 3 as measured by the 6-item Spielberger State Anxiety Scale.</measure>
      <time_frame>4 months</time_frame>
      <description>To assess the impact of Reiki therapy on pain in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.&#xD;
  The 6-item Spielberger State Anxiety Scale is a validated shortened version of the Spielberger State-Trait Anxiety Inventory (STAI) used to measure state anxiety. The scale utilizes a Likert scale with four response categories assigned numerical values from 1-4 (&quot;not at all,&quot;&quot;somewhat,&quot;&quot;moderately,&quot; and &quot;very much&quot;).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.</measure>
      <time_frame>4 months</time_frame>
      <description>To assess the impact of Reiki therapy on pain in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.&#xD;
  The Visual Analogue Scale (VAS) uses an 11-point scale ranging from 0 (no symptom) to 10 (worst possible symptom). Using the pain-VAS scoring system, 0 is considered no pain, 1 - 3 is considered mild, 4 - 6 is moderate to severe, 7 - 9 is very severe and 10 is categorized as worst possible pain.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comparison between the treatment groups of the change in state anxiety and depression from Assessment 1 to three month post-radiation as measured by the Hospital Anxiety and Depression Scale.</measure>
      <time_frame>4 months</time_frame>
      <description>To assess the impact of Reiki therapy on state anxiety and depression in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.&#xD;
  The Hospital Anxiety and Depression Scale (HADS) is a validated, self-assessment instrument used to identify caseness of anxiety disorders and depression in medical patients. It is comprised of 14 total questions, each of which are rated on a 4-point severity scale between zero (no impairment) and three (severe impairment). Total score range is 0 (normal/no impairment) to 21 (abnormal/severe impairment.)</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">68</enrollment>
    <condition>Gynecologic Neoplasm</condition>
    <condition>Brachytherapy</condition>
    <condition>Therapeutic Touch</condition>
    <condition>Endometrial Cancer</condition>
    <condition>Cervical Cancer</condition>
    <condition>Vaginal Cancer</condition>
    <condition>Vulvar Cancer</condition>
    <arm_group>
      <arm_group_label>Reiki Therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants randomized to Arm 1 will receive a session of Reiki therapy during the standard wait time between the placement of the brachytherapy device and their first brachytherapy treatment.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard of Care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Participants randomized to the standard of care control arm will be asked to remain in a clinic room during the standard waiting period between the placement of the brachytherapy device and the start of brachytherapy treatment. Participants may participate in any activity other than Reiki therapy during this time. Participants may be accompanied by a family member or friend.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Reiki therapy</intervention_name>
      <description>Reiki therapy is a form of energy healing that originated in Japan. It involves the transfer of energy from the Reiki practitioner to the recipient through the hands, with the goal of promoting physical, emotional, and spiritual well-being. Below is a general outline of the process of Reiki therapy, which may vary slightly depending on the needs of the recipient:&#xD;
  The patient will be in a quiet clinic room lying in the supine position with calming music playing and aromatherapy if the patient chooses.&#xD;
  The Reiki therapist will place their hands on or near the recipient's body. The Reiki therapist may use a series of hand positions that correspond to different energy centers in the body.&#xD;
  During the treatment, the practitioner channels energy into the recipient's body through their hands. The patient may feel a sense of warmth, tingling, or relaxation.&#xD;
  The Reiki therapist may use different techniques, such as hand movements or visualization.</description>
      <arm_group_label>Reiki Therapy</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject aged ≥ 18 years.&#xD;
  &#xD;
            -  Pathologically confirmed malignancy of the endometrium, cervix, vagina or vulva.&#xD;
  &#xD;
            -  Eligible to undergo brachytherapy treatment as an outpatient procedure.&#xD;
  &#xD;
            -  Able to read and understand English and/or Spanish.&#xD;
  &#xD;
            -  Able to provide informed consent and willing to sign an approved consent form that&#xD;
               conforms to federal and institutional guidelines.&#xD;
  &#xD;
            -  Willing to participate in either the Reiki therapy or standard of care arm regardless&#xD;
               of treatment assignment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Prior brachytherapy treatment for a gynecological malignancy.&#xD;
  &#xD;
            -  Medical, psychiatric, cognitive, or other conditions that may compromise the subject's&#xD;
               ability to understand the subject information, give informed consent, comply with the&#xD;
               study protocol or complete the study.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Lindsay Burt, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Huntsman Cancer Institute/ University of Utah</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Elyse D'Astous</last_name>
      <phone>801-587-4323</phone>
      <email>Elyse.DAstous@hci.utah.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Huntsman Cancer Institute</name>
        <address>
          <city>Salt Lake City</city>
          <state>Utah</state>
          <zip>84112</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Elyse D'Astous</last_name>
        <phone>801-587-4323</phone>
        <email>Elyse.DAstous@hci.utah.edu</email>
      </contact>
      <investigator>
        <last_name>Lindsay Burt, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 7, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Reiki</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Endometrial Neoplasms</mesh_term>
      <mesh_term>Vulvar Neoplasms</mesh_term>
      <mesh_term>Vaginal Neoplasms</mesh_term>
      <mesh_term>Genital Neoplasms, Female</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05979610
  org study id: HCI158391
  nct id: NCT05979610
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this open label, randomized, controlled clinical trial is to assess the benefits
        of providing Reiki therapy to subjects receiving their first brachytherapy treatment for
        gynecological malignancies.
  
        Participants will either receive a session of Reiki therapy or usual care during the standard
        wait time between the placement of the brachytherapy device and brachytherapy treatment.
        Questionnaires will be administered at various time points on the day of the participant's
        first brachytherapy treatment as well as at the three month follow-up time point.
  
        Researchers will compare the intervention (Reiki therapy) and control (usual care) groups to
        assess the impact of the Reiki therapy on anxiety, pain, state anxiety, depression, and
        physiological measurements.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Subjects who meet all criteria for enrollment will be randomly assigned to receive Reiki therapy (Arm 1) or usual care (Arm 2) using block randomization. Subjects will be randomized through the OnCore system in a 1:1 ratio to Arm 1 or Arm 2 and stratified by treatment type (multichannel vaginal cylinder (MCVC) and vaginal cylinder vs. all other treatment modalities). Randomization will not be blinded.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the 6-item Spielberger State Anxiety Scale.
  time frame: 4 months
  description: To assess the impact of Reiki therapy on anxiety in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.
  The 6-item Spielberger State Anxiety Scale is a validated shortened version of the Spielberger State-Trait Anxiety Inventory (STAI) used to measure state anxiety. The scale utilizes a Likert scale with four response categories assigned numerical values from 1-4 ("not at all,""somewhat,""moderately," and "very much").
  measure: Comparison between the treatment groups of the change in pain from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.
  time frame: 4 months
  description: To assess the impact of Reiki therapy on pain in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.
  The Visual Analogue Scale (VAS) uses an 11-point scale ranging from 0 (no symptom) to 10 (worst possible symptom). Using the pain-VAS scoring system, 0 is considered no pain, 1 - 3 is considered mild, 4 - 6 is moderate to severe, 7 - 9 is very severe and 10 is categorized as worst possible pain.
  measure: Comparison between the treatment groups of the change in anxiety from Assessment 2 to Assessment 3 as measured by the 6-item Spielberger State Anxiety Scale.
  time frame: 4 months
  description: To assess the impact of Reiki therapy on pain in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.
  The 6-item Spielberger State Anxiety Scale is a validated shortened version of the Spielberger State-Trait Anxiety Inventory (STAI) used to measure state anxiety. The scale utilizes a Likert scale with four response categories assigned numerical values from 1-4 ("not at all,""somewhat,""moderately," and "very much").
  measure: Comparison between the treatment groups of the change in anxiety from Assessment 1 to Assessment 3 as measured by the Visual Analog Scale - Pain.
  time frame: 4 months
  description: To assess the impact of Reiki therapy on pain in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.
  The Visual Analogue Scale (VAS) uses an 11-point scale ranging from 0 (no symptom) to 10 (worst possible symptom). Using the pain-VAS scoring system, 0 is considered no pain, 1 - 3 is considered mild, 4 - 6 is moderate to severe, 7 - 9 is very severe and 10 is categorized as worst possible pain.
  measure: Comparison between the treatment groups of the change in state anxiety and depression from Assessment 1 to three month post-radiation as measured by the Hospital Anxiety and Depression Scale.
  time frame: 4 months
  description: To assess the impact of Reiki therapy on state anxiety and depression in subjects undergoing brachytherapy treatment for gynecological malignancies compared to the usual care control arm.
  The Hospital Anxiety and Depression Scale (HADS) is a validated, self-assessment instrument used to identify caseness of anxiety disorders and depression in medical patients. It is comprised of 14 total questions, each of which are rated on a 4-point severity scale between zero (no impairment) and three (severe impairment). Total score range is 0 (normal/no impairment) to 21 (abnormal/severe impairment.)
  arm group label: Reiki Therapy
  arm group type: Experimental
  description: Participants randomized to Arm 1 will receive a session of Reiki therapy during the standard wait time between the placement of the brachytherapy device and their first brachytherapy treatment.
  arm group label: Standard of Care
  arm group type: No Intervention
  description: Participants randomized to the standard of care control arm will be asked to remain in a clinic room during the standard waiting period between the placement of the brachytherapy device and the start of brachytherapy treatment. Participants may participate in any activity other than Reiki therapy during this time. Participants may be accompanied by a family member or friend.
  intervention type: Other
  intervention name: Reiki therapy
  description: Reiki therapy is a form of energy healing that originated in Japan. It involves the transfer of energy from the Reiki practitioner to the recipient through the hands, with the goal of promoting physical, emotional, and spiritual well-being. Below is a general outline of the process of Reiki therapy, which may vary slightly depending on the needs of the recipient:
  The patient will be in a quiet clinic room lying in the supine position with calming music playing and aromatherapy if the patient chooses.
  The Reiki therapist will place their hands on or near the recipient's body. The Reiki therapist may use a series of hand positions that correspond to different energy centers in the body.
  During the treatment, the practitioner channels energy into the recipient's body through their hands. The patient may feel a sense of warmth, tingling, or relaxation.
  The Reiki therapist may use different techniques, such as hand movements or visualization.
  arm group label: Reiki Therapy
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Lindsay Burt, MD
  role: Principal Investigator
  affiliation: Huntsman Cancer Institute/ University of Utah
  last name: Elyse D'Astous
  phone: 801-587-4323
  email: Elyse.DAstous@hci.utah.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  responsible party type: Sponsor
  mesh term: Endometrial Neoplasms
  mesh term: Vulvar Neoplasms
  mesh term: Vaginal Neoplasms
  mesh term: Genital Neoplasms, Female
  sharing ipd: No