Physical Therapy: Dependent on Patient's Needs for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Breast CancerPhysical Therapy: Dependent on Patient's Needs - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial will have two phases. In phase one, the investigators will study 200 women, some with axillary web syndrome (AWS) and some without, to see if there is a correlation between AWS and metastatic disease or other conditions such as lymphedema, shoulder dysfunction, and pain. In phase two, which is a randomized controlled trial, the investigators will study 44 women with AWS, half of whom will receive physical therapy and half of whom will serve as a control group. The study will look at physical activity and physical impairments such as lymphedema, shoulder motion, function, and pain to see if physical therapy has

Treatment Effectiveness

Study Objectives

2 Primary · 9 Secondary · Reporting Duration: 1 Year

1 Month
DASH Score
1 Year
Axillary web syndrome status
Clinical characteristics of preoperative Auxillary Web Syndrome (AWS)
Function
Lymphedema
Pain level
Physical activity
Preoperative AWS and a positive lymph node status
Treatment Effects
1 month
Abduction range of motion (ROM)
Body mass index (BMI)

Trial Safety

Trial Design

2 Treatment Groups

Control Group
1 of 2
Physical Therapy Group
1 of 2

Active Control

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: Physical Therapy: Dependent on Patient's Needs · No Placebo Group · N/A

Physical Therapy Group
Behavioral
Experimental Group · 1 Intervention: Physical Therapy: Dependent on Patient's Needs · Intervention Types: Behavioral
Control GroupNoIntervention Group · 1 Intervention: Control Group · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor
259 Previous Clinical Trials
15,635 Total Patients Enrolled
21 Trials studying Breast Cancer
596 Patients Enrolled for Breast Cancer
Linda Koehler, PhD, PT, CLT-LANAPrincipal InvestigatorUniversity of Minnesota, Division of Physical Therapy

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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