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

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

Tracking Information

• First Submitted Date: July 24, 2014
• First Posted Date: July 30, 2014
• Last Update Posted Date: July 30, 2014
• Study Start Date: July 2014
• Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Occupational/Physical Therapy to Reduce Morbidity Post-Operative Bilateral Breast Reconstruction
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Occupational/Physical Therapy
• Post-operative Breast Reconstruction

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 28, 2014): 75
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: June 2015
• Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02203669
• Other Study ID Numbers: OTPT2014
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Tennessee
• Study Sponsor: University of Tennessee
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mark Brzezienski, MD; The University of Tennessee

• PRS Account: University of Tennessee
• Verification Date: July 2014