Frequently Asked Questions
Study Specific Questions
1. Who can participate in this clinical research Study?
To participate in this study, you or a loved one 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.
2. What will happen during my first visit to the study site?
You will meet with a study coordinator at a study site location closest to you. You will learn more about the research study and the benefits and risks of participation.
The study coordinator or study doctor 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. Different procedures will be performed to confirm that you qualify for the clinical study.
3. 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 on 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.
4. 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. This includes the initial visit 1 where you will consent 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. Visit 2 occurs at month 3 and involves follow-up surveillance for standard of care with the InBody 770 and circumference tape. OT/PT treatment is included if needed. The last 3 visits occur at month 6, month 9, and month 12 respectively, and include standard of care for complete decongestive therapy, with InBody 770 testing and circumference tape measurements.
5. Where are study centers/sites?
The study centers are located throughout the United States. Please see the study location section for details.
6. 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.
7. Will I have to pay to be part of this study?
No, there will be no cost to you for the study therapy or study procedures.
8. Will I need health insurance to participate?
No, health insurance is not a requirement to participate in this study. If you need treatment or care outside of the study, health insurance may be required.
Questions About Clinical Research Studies
1. What is a clinical trial?
Clinical trials, also known as clinical studies or research studies, are conducted by doctors and researchers to see if new medications, devices, or treatments are safe and effective before being approved for use by the public. Participation in a clinical trial is completely confidential and will be protected just like any other medical information.
2. Why are research studies important?
Research studies are used to test new medications and devices for safety, tolerability, and effectiveness before they are approved for use by the public.
3. Where can I learn more about research studies?
You can find out more information about clinical trials by browsing through www.clinicaltrials.gov. This is an online, government database that is managed by the National Library of Medicine. It provides information about both federally and privately supported clinical research studies.
4. What is informed consent?
All research studies require that doctors and/or researchers give interested participants complete and accurate information about the risks, benefits, and activities of a research study. Interested participants will sign an Informed Consent Form prior to enrolling in the study. This form shows that a participant understands what will happen during the study and that they can leave the study at any time.