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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Occupational/Physical Therapy; Post-operative Breast Reconstruction	Other: Home therapy; Other: Structured In-Office Therapy	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 75 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: The Use of Occupational/Physical Therapy to Reduce Upper Extremity Morbidity Post-Operative Bilateral Breast Reconstruction
• Study Start Date: July 2014
• Estimated Primary Completion Date: May 2015
• Estimated Study Completion Date: June 2015

Arms and Interventions

Arm	Intervention/treatment
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.	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.
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.	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.

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Tennessee

The Plastic Surgery Group, P.C.

Chattanooga, Tennessee, United States, 37403

Sponsors and Collaborators

University of Tennessee

Investigators

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

More Information

• Responsible Party: University of Tennessee
• ClinicalTrials.gov Identifier: NCT02203669
• Other Study ID Numbers: OTPT2014
• First Posted: July 30, 2014
• Last Update Posted: July 30, 2014
• Last Verified: July 2014

Keywords provided by University of Tennessee:

breast reconstruction; occupational therapy; physical therapy; upper extremity morbidity