<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/NCT03763838</url>
  </required_header>
  <id_info>
    <org_study_id>UMCC 2018.130</org_study_id>
    <secondary_id>HUM00143509</secondary_id>
    <nct_id>NCT03763838</nct_id>
  </id_info>
  <brief_title>Acupressure for Fatigue in Ovarian Cancer Survivors</brief_title>
  <official_title>Acupressure for Fatigue in Ovarian Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan Rogel Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan Rogel Cancer Center</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>
      The purpose of this study is to see if accupressure can help reduce the severity of fatigue&#xD;
      experienced by ovarian cancer patients. Acupressure involves applying mild to moderate&#xD;
      physical pressure by fingers, hand or a device to specific points on the skin to try to bring&#xD;
      about a change in the body's functioning, in this case relief from chronic fatigue.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 7, 2019</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">October 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participants in the &quot;standard of care&quot; arm will not be blinded; however, the two self-acupressure arms will be blinded as to which acupressure treatment they have been randomized. All study staff and researchers will remain blinded until after the completion of data analyses.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in level of fatigue at week 6</measure>
    <time_frame>Baseline to week 6</time_frame>
    <description>Self-reported on the Brief Fatigue Inventory (BFI)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in level of fatigue up to week 24</measure>
    <time_frame>Baseline up to week 24</time_frame>
    <description>Self-reported on the Brief Fatigue Inventory (BFI)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life at week 6</measure>
    <time_frame>Baseline to week 6</time_frame>
    <description>Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life up to week 24</measure>
    <time_frame>Baseline up to week 24</time_frame>
    <description>Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep quality at week 6</measure>
    <time_frame>Baseline to week 6</time_frame>
    <description>Self-reported on the Pittsburgh Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in sleep quality up to week 24</measure>
    <time_frame>Baseline up to week 24</time_frame>
    <description>Self-reported on the Pittsburgh Sleep Quality Index (PSQI)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">165</enrollment>
  <condition>Fatigue</condition>
  <condition>Ovarian Cancer</condition>
  <arm_group>
    <arm_group_label>Acupressure plus standard of care</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham acupressure plus standard of care</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Participants will receive standard of care only.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Acupressure</intervention_name>
    <description>Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).</description>
    <arm_group_label>Acupressure plus standard of care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sham acupressure</intervention_name>
    <description>Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.</description>
    <arm_group_label>Sham acupressure plus standard of care</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Fatigue management provided by participants' health care providers.</description>
    <arm_group_label>Acupressure plus standard of care</arm_group_label>
    <arm_group_label>Sham acupressure plus standard of care</arm_group_label>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 21 and older&#xD;
&#xD;
          -  Diagnosis of ovarian cancer, stages I to IV&#xD;
&#xD;
          -  Have average persistent fatigue defined a &gt;=4 on the Brief Fatigue Inventory at least&#xD;
             50% of their days for at least 3 months&#xD;
&#xD;
          -  Fatigue must have started at or after the diagnosis of ovarian cancer&#xD;
&#xD;
          -  Completed all primary cancer treatments (surgery, chemotherapy at least 6 months&#xD;
             prior), except maintenance therapies&#xD;
&#xD;
          -  No other planned interventions for fatigue other than current stable medication&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically unstable&#xD;
&#xD;
          -  Acupuncture or acupressure receipt in past year&#xD;
&#xD;
          -  Have a diagnosis of untreated mood disorder, e.g., bipolar or major depressive&#xD;
             disorder&#xD;
&#xD;
          -  Have a current diagnosis of anemia&#xD;
&#xD;
          -  Have a current untreated diagnosis of hypothyroidism&#xD;
&#xD;
          -  Have an initiation, a cessation or change of treatment of any chronic medications,&#xD;
             dietary supplements, behavioral therapy, physical therapy, etc., or any planned change&#xD;
             of medications, supplements or therapies during the study&#xD;
&#xD;
          -  Have the possibility of becoming pregnant&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Suzanna M Zick, ND, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Suzanna M Zick, ND, MPH</last_name>
    <phone>734-998-9553</phone>
    <email>szick@umich.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Michigan Rogel Cancer Center</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 3, 2018</study_first_submitted>
  <study_first_submitted_qc>December 3, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 4, 2018</study_first_posted>
  <last_update_submitted>April 5, 2023</last_update_submitted>
  <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Acupressure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ovarian Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Ovarian Epithelial</mesh_term>
    <mesh_term>Fatigue</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/NCT03763838
org study id: UMCC 2018.130
secondary id: HUM00143509
nct id: NCT03763838
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to see if accupressure can help reduce the severity of fatigue
      experienced by ovarian cancer patients. Acupressure involves applying mild to moderate
      physical pressure by fingers, hand or a device to specific points on the skin to try to bring
      about a change in the body's functioning, in this case relief from chronic fatigue.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Participants in the "standard of care" arm will not be blinded; however, the two self-acupressure arms will be blinded as to which acupressure treatment they have been randomized. All study staff and researchers will remain blinded until after the completion of data analyses.
measure: Change in level of fatigue at week 6
time frame: Baseline to week 6
description: Self-reported on the Brief Fatigue Inventory (BFI)
measure: Change in level of fatigue up to week 24
time frame: Baseline up to week 24
description: Self-reported on the Brief Fatigue Inventory (BFI)
measure: Change in quality of life at week 6
time frame: Baseline to week 6
description: Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)
measure: Change in quality of life up to week 24
time frame: Baseline up to week 24
description: Self-reported on the Functional Assessment of Cancer Therapy Ovarian (FACT-O)
measure: Change in sleep quality at week 6
time frame: Baseline to week 6
description: Self-reported on the Pittsburgh Sleep Quality Index (PSQI)
measure: Change in sleep quality up to week 24
time frame: Baseline up to week 24
description: Self-reported on the Pittsburgh Sleep Quality Index (PSQI)
arm group label: Acupressure plus standard of care
arm group type: Experimental
description: Using AcuWand, participants will apply acupressure to points that are known to affect physiology. Participants will also receive standard of care.
arm group label: Sham acupressure plus standard of care
arm group type: Sham Comparator
description: Using AcuWand, participants will apply acupressure to points that are not known to affect physiology. Participants will also receive standard of care.
arm group label: Standard of care
arm group type: Other
description: Participants will receive standard of care only.
intervention type: Other
intervention name: Acupressure
description: Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
arm group label: Acupressure plus standard of care
intervention type: Other
intervention name: Sham acupressure
description: Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
arm group label: Sham acupressure plus standard of care
intervention type: Other
intervention name: Standard of Care
description: Fatigue management provided by participants' health care providers.
arm group label: Acupressure plus standard of care
arm group label: Sham acupressure plus standard of care
arm group label: Standard of care
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Suzanna M Zick, ND, MPH
role: Principal Investigator
affiliation: University of Michigan
last name: Suzanna M Zick, ND, MPH
phone: 734-998-9553
email: szick@umich.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Ovarian Neoplasms
mesh term: Carcinoma, Ovarian Epithelial
mesh term: Fatigue
sharing ipd: No