<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/NCT01669187</url>
  </required_header>
  <id_info>
    <org_study_id>OU-4824</org_study_id>
    <nct_id>NCT01669187</nct_id>
  </id_info>
  <brief_title>The Effects of Pre-operative Physical Therapy Education</brief_title>
  <official_title>Phase 1 of the The Effects of Pre-operative Physical Therapy Education and Exercise on Patient Outcomes Post Breast Cancer Surgery: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oakland University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oakland University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is expected that patients who receive physical therapy before surgery will have greater&#xD;
      range of motion (ROM), strength, function, satisfaction, and less swelling, pain, and anxiety&#xD;
      following surgery compared to those in the control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Study withdrawn.&#xD;
  </why_stopped>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Change in score for Shoulder Pain and Disability Index (SPADI)</measure>
    <time_frame>Before sugery (range 0-4 weeks before surgery), 2 weeks post operatively and 6 weeks post-operatively</time_frame>
    <description>Functional outcome measure questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Shoulder range of motion with goniometer</measure>
    <time_frame>Pre-operatively (0-4 weeks pre-operatively), 2 and 6 weeks post-operatively</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in other physical therapy test and measures</measure>
    <time_frame>Once pre-operatively (0-4 weeks before surgery), 2 and 6 weeks after surgery</time_frame>
    <description>6 minute walk test; presence of cording; number of patient reported medical complications; shoulder strength measured by a dynamometer; Arm lymphedema measured by volumeter; Anxiety, general functional abilities, and QOL will be measured by the Functional Assessment of Cancer Therapy- Breast Cancer (FACT-B); Patient satisfaction will be measured using a 5 point Likert Scale.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Education brochure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group will receive a standard education brochure which will be provided pre-operatively to the participants.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Live education and exercise instruction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The intervention group will receive one to two physical therapy visits consisting of education on the lymphedema risks and prevention factors, along with detailed information about what to except post-surgery as well as with radiation/chemotherapy. Additionally, those in the intervention group will be instructed on exercises to maintain or increase glenohumeral and scapulothoracic joint ROM post surgery and will be set up with a walking program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Education brochure</intervention_name>
    <arm_group_label>Education brochure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Live education and exercise instruction</intervention_name>
    <description>Participants will receive one to two physical therapy visits consisting of education on the lymphedema risks and prevention factors, along with detailed information about what to except post-surgery as well as with radiation/chemotherapy. Additionally, those in the intervention group will be instructed on exercises to maintain or increase glenohumeral and scapulothoracic joint ROM post surgery and will be set up with a walking program.</description>
    <arm_group_label>Live education and exercise instruction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be over the age of 18,&#xD;
&#xD;
          -  have a good understanding of the English language, and&#xD;
&#xD;
          -  be scheduled to undergo either a mastectomy, lumpectomy, ALND or Sentinel Lymph Node&#xD;
             Dissection (SLND) with or without breast reconstruction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  if they previously underwent one of the previously mentioned procedures mastectomy,&#xD;
             lumpectomy, ALND or Sentinel Lymph Node Dissection (SLND) with or without breast&#xD;
             reconstruction.&#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>Marie-Eve S Pepin, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oakland University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St-Mary's of Michigan</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Mary's of Michigan</name>
      <address>
        <city>Saginaw</city>
        <state>Michigan</state>
        <zip>48601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>July 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 20, 2012</study_first_posted>
  <last_update_submitted>April 9, 2014</last_update_submitted>
  <last_update_submitted_qc>April 9, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</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/NCT01669187
org study id: OU-4824
nct id: NCT01669187
lead sponsor: 
has dmc: No
It is expected that patients who receive physical therapy before surgery will have greater
      range of motion (ROM), strength, function, satisfaction, and less swelling, pain, and anxiety
      following surgery compared to those in the control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Change in score for Shoulder Pain and Disability Index (SPADI)
time frame: Before sugery (range 0-4 weeks before surgery), 2 weeks post operatively and 6 weeks post-operatively
description: Functional outcome measure questionnaire
measure: Change in Shoulder range of motion with goniometer
time frame: Pre-operatively (0-4 weeks pre-operatively), 2 and 6 weeks post-operatively
measure: Change in other physical therapy test and measures
time frame: Once pre-operatively (0-4 weeks before surgery), 2 and 6 weeks after surgery
description: 6 minute walk test; presence of cording; number of patient reported medical complications; shoulder strength measured by a dynamometer; Arm lymphedema measured by volumeter; Anxiety, general functional abilities, and QOL will be measured by the Functional Assessment of Cancer Therapy- Breast Cancer (FACT-B); Patient satisfaction will be measured using a 5 point Likert Scale.
arm group label: Education brochure
arm group type: Active Comparator
description: The control group will receive a standard education brochure which will be provided pre-operatively to the participants.
arm group label: Live education and exercise instruction
arm group type: Experimental
description: The intervention group will receive one to two physical therapy visits consisting of education on the lymphedema risks and prevention factors, along with detailed information about what to except post-surgery as well as with radiation/chemotherapy. Additionally, those in the intervention group will be instructed on exercises to maintain or increase glenohumeral and scapulothoracic joint ROM post surgery and will be set up with a walking program.
intervention type: Other
intervention name: Education brochure
arm group label: Education brochure
intervention type: Other
intervention name: Live education and exercise instruction
description: Participants will receive one to two physical therapy visits consisting of education on the lymphedema risks and prevention factors, along with detailed information about what to except post-surgery as well as with radiation/chemotherapy. Additionally, those in the intervention group will be instructed on exercises to maintain or increase glenohumeral and scapulothoracic joint ROM post surgery and will be set up with a walking program.
arm group label: Live education and exercise instruction
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marie-Eve S Pepin, DPT
role: Principal Investigator
affiliation: Oakland University
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms