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Occupational/Physical Therapy to Reduce Morbidity Post-Operative Bilateral Breast Reconstruction

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ClinicalTrials.gov Identifier: NCT02203669
Recruitment Status : Unknown
Verified July 2014 by University of Tennessee.
Recruitment status was:  Enrolling by invitation
First Posted : July 30, 2014
Last Update Posted : July 30, 2014
Sponsor:
Information provided by (Responsible Party):
University of Tennessee

Tracking Information
First Submitted Date  ICMJE July 24, 2014
First Posted Date  ICMJE July 30, 2014
Last Update Posted Date July 30, 2014
Study Start Date  ICMJE July 2014
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 28, 2014)
Change in DASH: Disabilities of the Arm, Shoulder and Hand score [ Time Frame: Week 1 and Week 4 ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Occupational/Physical Therapy to Reduce Morbidity Post-Operative Bilateral Breast Reconstruction
Official Title  ICMJE The Use of Occupational/Physical Therapy to Reduce Upper Extremity Morbidity Post-Operative Bilateral Breast Reconstruction
Brief Summary

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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Occupational/Physical Therapy
  • Post-operative Breast Reconstruction
Intervention  ICMJE
  • Other: Home therapy
    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.
  • Other: Structured In-Office Therapy
    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.
Study Arms  ICMJE
  • Active Comparator: Structured In-Office Therapy
    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.
    Intervention: Other: Structured In-Office Therapy
  • No Intervention: No therapy
    Study subjects in this arm will not receive post-operative occupational /physical therapy. Will complete the DASH at week 1 and week 4.
  • Active Comparator: Home Therapy
    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: Other: Home therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: July 28, 2014)
75
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2015
Estimated Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age ≥ 18 years of age
  • Women who have had bilateral breast reconstruction
  • All cancer stages will be included
  • Physically and mentally able to participate in the study within the required time-frame
  • Able to voluntarily give full informed consent to participate in the study

Exclusion Criteria:

  • Women undergoing unilateral breast reconstruction
  • Unable to provide informed consent in English
  • Physically unable to engage in the protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02203669
Other Study ID Numbers  ICMJE OTPT2014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Tennessee
Study Sponsor  ICMJE University of Tennessee
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mark Brzezienski, MD The University of Tennessee
PRS Account University of Tennessee
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP