Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)

University of Minnesota (UMN)

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Physical Therapy: Dependent on Patient's Needs

Study type: Interventional

Funder types: Other

Identifiers

NCT04225572

2017NTLS119

PMR-2017-26231 (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age ≥ 18
• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 2 patient groups

Control Group

No Intervention group

Description:

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

Experimental group

Treatment:

Behavioral: Physical Therapy: Dependent on Patient's Needs