<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/NCT02203669</url>
  </required_header>
  <id_info>
    <org_study_id>OTPT2014</org_study_id>
    <nct_id>NCT02203669</nct_id>
  </id_info>
  <brief_title>Occupational/Physical Therapy to Reduce Morbidity Post-Operative Bilateral Breast Reconstruction</brief_title>
  <official_title>The Use of Occupational/Physical Therapy to Reduce Upper Extremity Morbidity Post-Operative Bilateral Breast Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tennessee</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Tennessee</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate the benefits of a structured&#xD;
      occupational/physical therapy program on upper extremity morbidity for patients who have&#xD;
      received bilateral breast reconstruction in comparison to a home therapy program and no&#xD;
      post-operative therapy.&#xD;
&#xD;
      Hypothesis: Patients who engage in therapist-supervised occupational therapy following&#xD;
      bilateral breast reconstruction have less upper extremity morbidity than those patients who&#xD;
      complete a home therapy program or no therapy program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Never did begin&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Anticipated">June 2015</completion_date>
  <primary_completion_date type="Anticipated">May 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in DASH: Disabilities of the Arm, Shoulder and Hand score</measure>
    <time_frame>Week 1 and Week 4</time_frame>
    <description>A change in DASH score will be calculated. The DASH: Disabilities of the Arm, Shoulder, and Hand (Appendix D) questionnaire will be utilized to measure physical function and symptoms of the upper limbs. The DASH consists of 30-items to be self-reported by the patient: physical function twenty-one (21) items, pain symptoms five (5) items, and emotional and social function four (4) items. The result of the DASH is a numerical disability score ranging from zero to one hundred (0-100), with zero (0) being no disability and one hundred (100) being the most severe disability.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Occupational/Physical Therapy</condition>
  <condition>Post-operative Breast Reconstruction</condition>
  <arm_group>
    <arm_group_label>Structured In-Office Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Structured In-Office Therapy: Study subjects will receive structured, therapist-supervised occupational/physical therapy twice per week for four (4) weeks. Each visit will last approximately sixty (60) minutes. Patients in this arm will receive therapy instruction by a certified occupational therapist on upper extremity stretching, relaxation, cardio rehabilitation, and strength training. These patients will also receive exercise and stretching handouts to use at home between therapy visits. Will complete the DASH at week 1 and week 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No therapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Study subjects in this arm will not receive post-operative occupational /physical therapy. Will complete the DASH at week 1 and week 4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Home Therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Home Therapy: Study subjects will receive a handout of exercises adapted for post-operative breast reconstruction patients along with an instructional handout for stretching complied by a certified occupational therapist to complete independently at home for four (4) weeks. Will complete the DASH at week 1 and week 4.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Home therapy</intervention_name>
    <description>Study subjects complete home therapy independently for four (4) weeks based on handouts of exercises adapted for post-operative breast reconstruction patients along with an instructional handout for stretching complied by a certified occupational therapist.</description>
    <arm_group_label>Home Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Structured In-Office Therapy</intervention_name>
    <description>Study subjects will participate in Structured In-Office Therapy twice a week for four (4) weeks. Each visit will last approximately sixty (60) minutes. Subjects will receive therapy instruction by a certified occupational therapist on upper extremity stretching, relaxation, cardio rehabilitation, and strength training. These subjects will also receive exercise and stretching handouts to use at home between therapy visits.</description>
    <arm_group_label>Structured In-Office Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years of age&#xD;
&#xD;
          -  Women who have had bilateral breast reconstruction&#xD;
&#xD;
          -  All cancer stages will be included&#xD;
&#xD;
          -  Physically and mentally able to participate in the study within the required&#xD;
             time-frame&#xD;
&#xD;
          -  Able to voluntarily give full informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women undergoing unilateral breast reconstruction&#xD;
&#xD;
          -  Unable to provide informed consent in English&#xD;
&#xD;
          -  Physically unable to engage in the protocol&#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>Mark Brzezienski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Tennessee</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Plastic Surgery Group, P.C.</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37403</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 28, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>May 19, 2023</last_update_submitted>
  <last_update_submitted_qc>May 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>breast reconstruction</keyword>
  <keyword>occupational therapy</keyword>
  <keyword>physical therapy</keyword>
  <keyword>upper extremity morbidity</keyword>
  <!-- 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/NCT02203669
org study id: OTPT2014
nct id: NCT02203669
lead sponsor: 
has dmc: No
The purpose of this study is to demonstrate the benefits of a structured
      occupational/physical therapy program on upper extremity morbidity for patients who have
      received bilateral breast reconstruction in comparison to a home therapy program and no
      post-operative therapy.

      Hypothesis: Patients who engage in therapist-supervised occupational therapy following
      bilateral breast reconstruction have less upper extremity morbidity than those patients who
      complete a home therapy program or no therapy program.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Change in DASH: Disabilities of the Arm, Shoulder and Hand score
time frame: Week 1 and Week 4
description: A change in DASH score will be calculated. The DASH: Disabilities of the Arm, Shoulder, and Hand (Appendix D) questionnaire will be utilized to measure physical function and symptoms of the upper limbs. The DASH consists of 30-items to be self-reported by the patient: physical function twenty-one (21) items, pain symptoms five (5) items, and emotional and social function four (4) items. The result of the DASH is a numerical disability score ranging from zero to one hundred (0-100), with zero (0) being no disability and one hundred (100) being the most severe disability.
arm group label: Structured In-Office Therapy
arm group type: Active Comparator
description: Structured In-Office Therapy: Study subjects will receive structured, therapist-supervised occupational/physical therapy twice per week for four (4) weeks. Each visit will last approximately sixty (60) minutes. Patients in this arm will receive therapy instruction by a certified occupational therapist on upper extremity stretching, relaxation, cardio rehabilitation, and strength training. These patients will also receive exercise and stretching handouts to use at home between therapy visits. Will complete the DASH at week 1 and week 4.
arm group label: No therapy
arm group type: No Intervention
description: Study subjects in this arm will not receive post-operative occupational /physical therapy. Will complete the DASH at week 1 and week 4.
arm group label: Home Therapy
arm group type: Active Comparator
description: Home Therapy: Study subjects will receive a handout of exercises adapted for post-operative breast reconstruction patients along with an instructional handout for stretching complied by a certified occupational therapist to complete independently at home for four (4) weeks. Will complete the DASH at week 1 and week 4.
intervention type: Other
intervention name: Home therapy
description: Study subjects complete home therapy independently for four (4) weeks based on handouts of exercises adapted for post-operative breast reconstruction patients along with an instructional handout for stretching complied by a certified occupational therapist.
arm group label: Home Therapy
intervention type: Other
intervention name: Structured In-Office Therapy
description: Study subjects will participate in Structured In-Office Therapy twice a week for four (4) weeks. Each visit will last approximately sixty (60) minutes. Subjects will receive therapy instruction by a certified occupational therapist on upper extremity stretching, relaxation, cardio rehabilitation, and strength training. These subjects will also receive exercise and stretching handouts to use at home between therapy visits.
arm group label: Structured In-Office Therapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mark Brzezienski, MD
role: Principal Investigator
affiliation: The University of Tennessee
facility: 
country: United States
responsible party type: Sponsor