<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/NCT04458194</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00004405</org_study_id>
    <nct_id>NCT04458194</nct_id>
  </id_info>
  <brief_title>Comparing Virtual Yoga to Standard Care on Insomnia Among Cancer Survivors</brief_title>
  <official_title>A Feasibility Trial Comparing the Effectiveness of Virtual YOCAS©® Yoga to Standard Care for Treating Insomnia in Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rochester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bassett Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Rochester</source>
  <oversight_info>
    <has_dmc>No</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>
      This feasibility phase II randomized controlled trial examines the preliminary efficacy of&#xD;
      our standardized four-week YOCAS©® (Yoga for Cancer Survivors) intervention that is delivered&#xD;
      virtually on insomnia and sleep quality in cancer survivors.&#xD;
&#xD;
      Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty&#xD;
      staying asleep, or waking up earlier than desired. The vast majority of patients with cancer&#xD;
      experience some form of sleep impairment post-treatment. Yoga is safe, feasible, and&#xD;
      effective for improving insomnia and sleep quality in cancer survivors. However, most of the&#xD;
      yoga intervention was delivered in person. With the challenges and the social distancing&#xD;
      regulation regarding the COVID-19 pandemic, adapting to virtual behavioral intervention is&#xD;
      critically important and needed. Whether the yoga intervention delivered virtually to&#xD;
      survivors provides a similar benefit of improving insomnia and sleep quality is unknown.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      To compare the effects of virtual YOCAS©® intervention to standard care on changes in&#xD;
      insomnia measured via the Insomnia Severity Index among cancer survivors&#xD;
&#xD;
      SECONDARY OBJECTIVE:&#xD;
&#xD;
      To compare the effects of virtual YOCAS©® intervention to standard care on changes in sleep&#xD;
      quality measured via the Pittsburgh Sleep Quality Index among cancer survivors&#xD;
&#xD;
      OUTLINE: Cancer survivors are randomized to 1 of 2 arms.&#xD;
&#xD;
      ARM I: Standard Care: Cancer survivors receive their standard care&#xD;
&#xD;
      ARM II: YOCAS©® intervention: Cancer survivors participate in 8 virtual YOCAS sessions (75&#xD;
      minutes/session, 2 times a week for 4 weeks) delivered via the electronic platform (e.g.,&#xD;
      Zoom)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 12, 2022</start_date>
  <completion_date type="Anticipated">November 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2023</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>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean change in insomnia as measured by the Insomnia Severity Index (ISI) total score comparing cancer survivors in YOCAS vs. Standard Care</measure>
    <time_frame>baseline to week 5</time_frame>
    <description>The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change among cancer survivors in YOCAS vs. Standard Care</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mean Change in sleep quality as measured by the Pittsburgh Sleep Quality Inventory (PSQI) total Score comparing cancer survivors in YOCAS vs. Standard Care</measure>
    <time_frame>baseline to week 5</time_frame>
    <description>The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change among cancer survivors in YOCAS vs. Standard Care</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">42</enrollment>
  <condition>Insomnia</condition>
  <arm_group>
    <arm_group_label>Standard Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Cancer survivors receive their standard care</description>
  </arm_group>
  <arm_group>
    <arm_group_label>YOCAS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cancer survivors receive 8 virtual yoga sessions (75 minutes/session, 2 times a week for 4 weeks) delivered via an electronic platform (e.g., Zoom)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard Care</intervention_name>
    <description>Standard Care is used as a control condition. Cancer survivors assigned to this arm continue to receive standard care from their medical providers.</description>
    <arm_group_label>Standard Care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>YOCAS©® yoga</intervention_name>
    <description>Yoga for Cancer Survivors, YOCAS©®, intervention is a low to moderate intensity mode of exercise that draws from two basic types of yoga; gentle Hatha and Restorative yoga. The program includes specific physical postures and mindfulness exercises focused on breathing and meditation. Cancer survivors will participate in 8 virtual YOCAS sessions (75 minutes/session, 2 times a week for 4 weeks) delivered via an electronic platform (e.g., Zoom)</description>
    <arm_group_label>YOCAS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Cancer Survivors must:&#xD;
&#xD;
          -  have a confirmed diagnosis of cancer&#xD;
&#xD;
          -  have received surgery, chemotherapy, and/or radiation therapy&#xD;
&#xD;
          -  have completed all surgery, chemotherapy, and/or radiation therapy within the last 2&#xD;
             months to 10 years&#xD;
&#xD;
          -  score ≥4 on a 0-10 sleep screening scale&#xD;
&#xD;
          -  be at least 18 years of age&#xD;
&#xD;
          -  be able to read and understand English&#xD;
&#xD;
          -  be able to provide informed consent&#xD;
&#xD;
          -  have access to the internet and a smartphone, tablet, and/or computer&#xD;
&#xD;
          -  have the ability to attend 8 virtual yoga sessions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Cancer Survivor must not:&#xD;
&#xD;
          -  have contraindications to yoga participation&#xD;
&#xD;
          -  have practiced yoga within the 3 months prior to enrolling in the study&#xD;
&#xD;
          -  be planning to start yoga on their own during the time they are enrolled in the study&#xD;
&#xD;
          -  have a confirmed diagnosis of sleep apnea or restless leg syndrome&#xD;
&#xD;
          -  be receiving any form of treatment for cancer with the exception of hormonal or&#xD;
             biologic therapy&#xD;
&#xD;
          -  have distant metastases&#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>Karen Mustian, PhD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Rochester</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Brittany LaVaute, MS</last_name>
    <phone>585-276-4059</phone>
    <email>Brittany_LaVaute@URMC.Rochester.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Po-Ju Lin, PhD, MPH</last_name>
    <phone>585-276-6001</phone>
    <email>po-ju_lin@urmc.rochester.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Bassett Research Institute</name>
      <address>
        <city>Cooperstown</city>
        <state>New York</state>
        <zip>13326</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Melinda Robinson</last_name>
      <phone>607-547-6707</phone>
      <email>melinda.robinson@bassett.org</email>
    </contact>
    <contact_backup>
      <last_name>Kristin Pullyblank, RN, MS</last_name>
      <phone>607-547-6711</phone>
      <email>kristin.pullyblank@bassett.org</email>
    </contact_backup>
    <investigator>
      <last_name>Wendy Brunner, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Brittany LaVaute, MS</last_name>
      <phone>585-276-4059</phone>
      <email>Brittany_LaVaute@URMC.Rochester.edu</email>
    </contact>
    <investigator>
      <last_name>Karen Mustian, PhD, MPH</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 18, 2023</last_update_submitted>
  <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rochester</investigator_affiliation>
    <investigator_full_name>Karen Mustian</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>Sleep Initiation and Maintenance Disorders</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/NCT04458194
org study id: STUDY00004405
nct id: NCT04458194
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This feasibility phase II randomized controlled trial examines the preliminary efficacy of
      our standardized four-week YOCAS©® (Yoga for Cancer Survivors) intervention that is delivered
      virtually on insomnia and sleep quality in cancer survivors.

      Insomnia can be described as excessive daytime napping, difficulty falling asleep, difficulty
      staying asleep, or waking up earlier than desired. The vast majority of patients with cancer
      experience some form of sleep impairment post-treatment. Yoga is safe, feasible, and
      effective for improving insomnia and sleep quality in cancer survivors. However, most of the
      yoga intervention was delivered in person. With the challenges and the social distancing
      regulation regarding the COVID-19 pandemic, adapting to virtual behavioral intervention is
      critically important and needed. Whether the yoga intervention delivered virtually to
      survivors provides a similar benefit of improving insomnia and sleep quality is unknown.
PRIMARY OBJECTIVE:

      To compare the effects of virtual YOCAS©® intervention to standard care on changes in
      insomnia measured via the Insomnia Severity Index among cancer survivors

      SECONDARY OBJECTIVE:

      To compare the effects of virtual YOCAS©® intervention to standard care on changes in sleep
      quality measured via the Pittsburgh Sleep Quality Index among cancer survivors

      OUTLINE: Cancer survivors are randomized to 1 of 2 arms.

      ARM I: Standard Care: Cancer survivors receive their standard care

      ARM II: YOCAS©® intervention: Cancer survivors participate in 8 virtual YOCAS sessions (75
      minutes/session, 2 times a week for 4 weeks) delivered via the electronic platform (e.g.,
      Zoom)
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Investigator, Outcomes Assessor)
measure: Mean change in insomnia as measured by the Insomnia Severity Index (ISI) total score comparing cancer survivors in YOCAS vs. Standard Care
time frame: baseline to week 5
description: The Insomnia Severity Index is a validated measure of insomnia. A 5-point Likert scale of 7 questions is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28 with higher scores indicating higher severity of insomnia. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change among cancer survivors in YOCAS vs. Standard Care
measure: Mean Change in sleep quality as measured by the Pittsburgh Sleep Quality Inventory (PSQI) total Score comparing cancer survivors in YOCAS vs. Standard Care
time frame: baseline to week 5
description: The PSQI measures sleep quality with a total score ranging from 0-21 with higher scores indicating worse sleep quality. A linear mixed effects ANCOVA will be used to assess the statistical significance of the differences in mean change among cancer survivors in YOCAS vs. Standard Care
arm group label: Standard Care
arm group type: Active Comparator
description: Cancer survivors receive their standard care
arm group label: YOCAS
arm group type: Experimental
description: Cancer survivors receive 8 virtual yoga sessions (75 minutes/session, 2 times a week for 4 weeks) delivered via an electronic platform (e.g., Zoom)
intervention type: Other
intervention name: Standard Care
description: Standard Care is used as a control condition. Cancer survivors assigned to this arm continue to receive standard care from their medical providers.
arm group label: Standard Care
intervention type: Behavioral
intervention name: YOCAS©® yoga
description: Yoga for Cancer Survivors, YOCAS©®, intervention is a low to moderate intensity mode of exercise that draws from two basic types of yoga; gentle Hatha and Restorative yoga. The program includes specific physical postures and mindfulness exercises focused on breathing and meditation. Cancer survivors will participate in 8 virtual YOCAS sessions (75 minutes/session, 2 times a week for 4 weeks) delivered via an electronic platform (e.g., Zoom)
arm group label: YOCAS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Karen Mustian, PhD, MPH
role: Principal Investigator
affiliation: University of Rochester
last name: Brittany LaVaute, MS
phone: 585-276-4059
email: Brittany_LaVaute@URMC.Rochester.edu
last name: Po-Ju Lin, PhD, MPH
phone: 585-276-6001
email: po-ju_lin@urmc.rochester.edu
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Rochester
investigator full name: Karen Mustian
investigator title: Professor
mesh term: Sleep Initiation and Maintenance Disorders