Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Clinical characteristics of preoperative Auxillary Web Syndrome (AWS)
Study Overview
Brief Summary
Phase 1: The investigators will conduct a prospective study to quantify the association between axillary web syndrome (AWS) and metastatic disease and chronic morbidities such as lymphedema, shoulder dysfunction, and pain comparing women (i) with AWS and (ii) without AWS in two cohorts of women. (n=200) Phase 2: This is a randomized controlled trial to 1) quantify the effects of (i) physical therapy compared to (ii) a control group in individuals with AWS following breast cancer surgery related to physical activity and physical impairments such as lymphedema, shoulder motion, function, and pain (n=44, 22 in each group). Funding to progress to Phase 2 of this trial has been obtained. It is anticipated 120 subjects participating in Phase 1 will be screened for eligibility for Phase 2 (separate consent and eligibility from Phase 1).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients (female or male) with a tissue diagnosis of non-invasive or invasive breast cancer
- •Planned surgical breast cancer treatment (lumpectomy or mastectomy) with a minimum removal of one axillary lymph node by sentinel node biopsy. Contralateral prophylactic mastectomy or bilateral mastectomy is allowed.
- •Voluntary written consent signed before performance of any study-related procedure not part of normal medical care
Exclusion Criteria
- •Patients (patients unable to travel easily to the University of Minnesota Medical Center for post-surgery visits).
- •Synchronous bilateral breast cancer
- •Presence of a medical complication that would prevent the patient from being able to participate in the study, such as terminal cancer
- •Previous history of upper extremity deep vein thrombosis
- •Breast cancer surgery without lymph node removal
Arms & Interventions
Control Group
Patient will not receive physical therapy treatment or further instruction from the research team. The patient will receive standard care recommended by their medical provider which may or may not include physical therapy treatment.
Physical Therapy Group
Intervention: Physical Therapy: Dependent on Patient's Needs (Behavioral)
Outcomes
Primary Outcomes
Clinical characteristics of preoperative Auxillary Web Syndrome (AWS)
Time Frame: 1 Year
Status of lymph nodes in women who have preoperative AWS (lymph node metastasis present or not)
Treatment Effects
Time Frame: 1 Year
Range of motion (ROM) will be measured using a standard goniometer
Secondary Outcomes
- Abduction range of motion (ROM)(1 month)
- Body mass index (BMI)(1 month)
- Function(1 Year)
- Physical activity(1 Year)
- Axillary web syndrome status(1 Year)
- DASH Score(1 Month)
- Pain level(1 Year)
- Lymphedema(1 Year)
- Preoperative AWS and a positive lymph node status(1 Year)