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

University of Tennessee

Status: Withdrawn

Conditions: Occupational/Physical Therapy; Post-operative Breast Reconstruction

Treatments: Other: Home therapy; Other: Structured In-Office Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02203669

OTPT2014

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 3 patient groups

Structured In-Office Therapy

Active Comparator group

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.

Treatment:

Other: Structured In-Office Therapy

No therapy

No Intervention group

Description:

Study subjects in this arm will not receive post-operative occupational /physical therapy. Will complete the DASH at week 1 and week 4.

Home Therapy

Active Comparator group

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.

Treatment:

Other: Home therapy