<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/NCT01667328</url>
  </required_header>
  <id_info>
    <org_study_id>2012-2</org_study_id>
    <nct_id>NCT01667328</nct_id>
  </id_info>
  <brief_title>Preoperative Massage in Breast Surgery Patients</brief_title>
  <official_title>Utility of Preoperative Massage in Breast Surgery Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vassar Brothers Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Health Quest Systems</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dyson Center for Cancer Care</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Vassar Brothers Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized controlled interventional study is designed to determine whether breast&#xD;
      cancer surgical patients receiving presurgical massage therapy performed by a licensed&#xD;
      massage therapist have decreased average anxiety levels compared to the control group of&#xD;
      breast cancer surgical patients who do not receive massage therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">March 19, 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Anxiety level</measure>
    <time_frame>Upon arrival at the hospital for scheduled surgery and again immediately prior to surgery. Expected interval between measurements estimated to be less than 120 minutes.</time_frame>
    <description>Assessments will be done immediately post registration and immediately prior to surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">299</enrollment>
  <condition>Anxiety</condition>
  <condition>Presurgical Anxiety</condition>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Massage therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will received presurgical massage</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard of care with no massage</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Massage therapy</intervention_name>
    <description>Presurgical 15 minute massage performed by a licensed massage therapist</description>
    <arm_group_label>Massage therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Control group will receive standard of care with no massage therapy</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  Must speak English&#xD;
&#xD;
          -  Able to give consent&#xD;
&#xD;
          -  18 years of age or older&#xD;
&#xD;
          -  Undergoing first procedure outpatient breast/axillary surgery at Vassar Brothers&#xD;
             Medical Center&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anxiolytics or antidepressants medications during the previous 24 hours&#xD;
&#xD;
          -  Any condition that would prohibit receiving a massage&#xD;
&#xD;
          -  IV medications prior to presurgical holding VAS assessment&#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>Angela Keleher, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vassar Brothers Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vassar Brothers Medical Center</name>
      <address>
        <city>Poughkeepsie</city>
        <state>New York</state>
        <zip>12601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.healthquest.org/clinical-research/clinical-research.aspx</url>
    <description>Vassar Brothers Medical Center's Dyson Center for Cancer Care</description>
  </link>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>June 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>April 30, 2018</last_update_submitted>
  <last_update_submitted_qc>April 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Anxiety</keyword>
  <keyword>Presurgical anxiety</keyword>
  <keyword>Breast Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety 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/NCT01667328
org study id: 2012-2
nct id: NCT01667328
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This randomized controlled interventional study is designed to determine whether breast
      cancer surgical patients receiving presurgical massage therapy performed by a licensed
      massage therapist have decreased average anxiety levels compared to the control group of
      breast cancer surgical patients who do not receive massage therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Anxiety level
time frame: Upon arrival at the hospital for scheduled surgery and again immediately prior to surgery. Expected interval between measurements estimated to be less than 120 minutes.
description: Assessments will be done immediately post registration and immediately prior to surgery
arm group label: Massage therapy
arm group type: Experimental
description: This group will received presurgical massage
arm group label: Control
arm group type: Placebo Comparator
description: Standard of care with no massage
intervention type: Procedure
intervention name: Massage therapy
description: Presurgical 15 minute massage performed by a licensed massage therapist
arm group label: Massage therapy
intervention type: Procedure
intervention name: Standard of care
description: Control group will receive standard of care with no massage therapy
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Angela Keleher, M.D.
role: Principal Investigator
affiliation: Vassar Brothers Medical Center
facility: 
country: United States
url: https://www.healthquest.org/clinical-research/clinical-research.aspx
description: Vassar Brothers Medical Center's Dyson Center for Cancer Care
responsible party type: Sponsor
mesh term: Anxiety Disorders