Physical Rehabilitation Evaluation and Optimal Physical Therapy (PREOPT)
Individuals diagnosed with breast cancer who will be having surgery will be recruited for this study. The overall goal of this research is to see whether or not physical therapy can improve the quality of life during and after breast cancer treatment.
We will do this by specifically looking at:
- Axillary web syndrome (AWS) (tight cord in the armpit region that can develop following breast
- cancer surgery)
- Lymphedema (abnormal swelling due to a damaged lymphatic system)
- Shoulder Function (how well your arm moves)
- Quality of Life (questionnaires that ask about pain level, physical activity, ect.)
We will use this information to learn more about how AWS affects shoulder movement, lymphedema, and how you feel overall. This study will help us see whether or not physical therapy is successful in treating AWS and lymphedema. We hope to provide doctors and physical therapists with better tools to identify and treat these issues. This can lead to more comprehensive medical care that can help improve pain, stiffness, function, and quality of life.
Participant Timeline
Phase 1
Prior to your surgical date (ideally at the surgical consult appointment), the research team meets with you to explain the study, determine if you are eligible, and answer any questions that you may have. If you are eligible and would like to participate, you will be asked to sign the consent form. There are two visits to Phase 1.
- Visit 1 can occur the same day that you consent. This visit will last about 30 minutes and will consist of the research team taking measurements. Please see the FAQ section for measurement details.
- Visit 2 is usually scheduled at the same time as your appointment with your surgeon, about 2 weeks after surgery. The research team will take the same measurements as Visit 1.
- If you have signs of axillary web syndrome (AWS), you will be given the option to participate in Phase 2.
- For those without AWS, this will be the final visit of the study.
Phase 2
Participants in Phase 2 will be divided into 2 groups.
- One group will be given the standard care treatment that is recommended by their doctor.
- The second group will undergo up to 3 months of physical therapy sessions that will focus on shoulder flexibility/strength, swelling control, and improving your ability to do your daily physical activities.
At 3 months, both groups will meet with the Research Team one more time for a repeat of the measurements taken previously.
FAQ
How long does each visit with the Research Team take?
The Phase 1 visits take approximately 30-45 minutes. If you are in the physical therapy group of Phase 2, treatment visits will last about an hour per visit.
What kind of measurements are taken by the Research Team?
All measurements taken are noninvasive.
- Goniometry will be used to measure your shoulder movement. A goniometer is a plastic tool that measures how far you can lift and rotate your arm.
- A tape measure will be used to measure the distance around your arm at multiple points. This measurement will be taken on both arms.
- Bioimpedance spectroscopy (BIS) measures the amount of fluid in your body. Electrodes will be placed on 3 limbs which will measure the amount of fluid in the limb that is at risk for lymphedema.
- Tissue dielectric constant (TDC) measures the water content in tissues at specific points along the limb and trunk.
- Axillary Web Syndrome assessment: The researcher will look for visible cords in your arms, shoulders, and trunk.
Who gets to be in the Phase 2 physical therapy group?
A computer randomizes who is to be included in the physical therapy group, and who will get standard care.
Will being in this study help me in any way?
We can not promise any benefits to you or others from your taking part in this research.
Possible benefits include receiving physical therapy which may improve your post-surgery rehabilitation. There also may be benefit in receiving early assessments to diagnose AWS and/or lymphedema. In addition, the results of this study may help guide future standard of care practices for patients who have received surgery for breast cancer.
Axillary Web Syndrome (AWS) feels like a tight cord of tissue that develops in the armpit region. It is a common condition that can occur after breast cancer surgery. It sometimes extends down the arm and/or trunk, and there may be multiple cords. The cords can cause pain and limited movement of the arm.
Symptoms of AWS:
● The cord-like areas can often be felt and sometimes seen.
● When raising your arm, the cords become more obvious and can limit your ability to lift your arm above shoulder height due to pain and a pulling sensation.
● These restrictions can make it difficult to do daily activities.
Those who have had lymph nodes in their armpit area surgically removed or who have had radiation to this area are at risk for developing AWS.
Factors that increase the risk include:
● type and extent of surgery
● lower body mass index
● chemotherapy and/or radiation therapy
● younger age
Although AWS most often occurs 2-8 weeks following surgery, it can appear months to years later. Occasionally we detect it before surgery. Click the button below to view an image of AWS.
Study Status
On Hold due to COVID-19
Funding
BIRCWH award #K12HD055887
(Sponsored by the Eunice Kennedy Shriver National Institute of Child Health and Human Development of the National Institutes of Health)
Contact
Contact us with no obligation to participate.
Dr. Linda Koehler
Principal Investigator
koeh0139@umn.edu
612-626-1502