Lymphedema Detection Research Study

Individuals diagnosed with breast cancer who have undergone breast cancer surgery with lymph node removal within the last 12 months will be recruited for this study. The overall goal of this research is to find out if the use of a home body water analyzer device, called InBody BWA ON, is effective in detecting and monitoring lymphedema in adults who have had breast cancer-related surgery in the last 12 months prior to enrollment.

We will do this by specifically looking at:

Lymphedema (abnormal swelling due to a damaged lymphatic system)
Shoulder movement and function (how well your arm moves)
Quality of Life (questionnaires that ask about pain level, physical activity, etc.)

What the study entails:

Five in-person study-related physical therapy assessments to be carried out at the Cancer Survivorship and Lymphology Research Lab on the University of Minnesota Campus
An at-home use of BWA ON device, which will be provided at no cost to the participant for the duration of the study. The at-home device will be used daily by the participant in the comfort of their own home.
The planned length of time of the study is approximately 12 months, including screening, treatment time, and follow-up.
Participants will be compensated for their time and parking fees will be waived.
Up to 200 participants will be enrolled in this study throughout the United States.

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Participant Timeline

All participants who are eligible and successfully enroll in this study will participate for up to approximately 12 months.

Initial visit 1: This visit includes consenting to participate and the initial evaluation consisting of taking baseline parameters. This visit is when the participants will receive the InBody BWA ON device and are shown how to use it. This visit will last about 60-90 minutes. Please see the FAQ for measurement details.

Visit 2-4: This next 3 visits occur at month 3, month 6, and month 9 and involve repeat of baseline parameters. These visits will last approximately 60 minutes.

Visit 5: The last visit occurs at month 12 and includes repeat of baseline parameters and an exit interview to review your experience with the InBody BWE ON device. This visit will last about 60-90 minutes.

FAQ

Who Can Participate In This Clinical Research Study?

To participate in this study, individuals must:

Be an adult aged 18 or older
Have a medical diagnosis of unilateral (on one side) breast cancer
Have had breast cancer-related surgery within the last 12 months prior to enrollment

There are additional criteria that are reviewed by the study team during your first appointment.

What Will Happen During My First Visit To The Study Site?

You will meet with a study coordinator at the Cancer Survivorship and Lymphology Research Lab located at the University of Minnesota-Twin Cities Campus in the Children’s Rehabilitation Building. You will learn more about the research study and the benefits and risks of participation.

A study member will review the Informed Consent Form with you. You will have the chance to ask any questions about this form, and sign once comfortable and willing to participate in the study.

What Is The Device, The InBody BWA ON, That Is Being Tested During These Studies And How Does It Work?

The InBody BWA ON is a body composition assessment device that sends safe, low-level electrical currents through the body’s water. The amount of resistance the current experiences as it passes through body water determines a patient’s body water, lean mass, and fat measures. The device gives results providing information on the ratio of fluids in the body and compartmental water changes as part of health status.

Changes in fluid levels appear to be correlated with arm circumference changes, so the BWA ON allows monitoring of these values.

By monitoring the fluids levels at home, at different times of day, it may allow early detection of lymphedema in the future due to changes of the ratio of extracellular water to the total water in the body.

Use of the InBody BWA ON is easy, fast, and allows for valid and reproducible results.

What will Happen During This Study?

All participants who are eligible and successfully enroll in this study will participate for up to approximately 12 months.

Initial visit 1: This visit includes consenting to participate, and will receive the initial evaluation, which collects baseline parameters and occurs 1-12 months post-surgery. This visit is when the participants receive the InBody BWA ON device and are shown how to use it. You will be compensated $100 for your time and parking will be waived.

Baseline parameters: Body composition, lymphedema measures, flexibility measures, and questionnaires.

Visit 2-4: This next 3 visits occur at month 3, month 6, and month 9 and involves repeat of baseline parameters. You will be compensated $100 for your time for each visit that you attend and parking will be waived.

Visit 5: The last visit occurs at month 12 and includes repeat of baseline parameters and an exit interview to review your experience with the InBody BWE ON device. You will be compensated $100 for your time and parking will be waived. You will also be compensated another $100 for completing all visits in the study.

Where Are Study Centers/Sites?

Cancer Survivorship and Lymphology Research Lab located at the University of Minnesota-Twin Cities Campus in the Children’s Rehabilitation Building.

If I Am Taking Any Medication, Do I Need To Stop Before Participating In The Study?

You do not have to stop taking your medication unless you are advised to do so by your physician.

Will I Have to Pay to be Part of Thus Study?

No, there will be no cost to you for the study therapy or study procedures.

Will I Need Health Insurance to Participate?

No, health insurance is not a requirement to participate in this study.