JMIR Publications

ABSTRACT

Background:

Breast cancer-related lymphedema (BCRL) is a common complication of surgery. Although guidelines for diagnosing and staging lymphedema exist, the exact classification may differ among clinicians. Additionally, patients are often referred for treatment once symptoms are reported, which, in some cases, may be too late.

Objective:

The first aim of this study was to confirm the effectiveness of the home-based body water analyzer used for daily patient monitoring after breast cancer surgery. To accomplish this, we first confirmed the reliability of the home device compared to a professional bioelectrical impedance analysis (BIA) device. Then we determined the best time of day for the test (Before-Noon or After-Noon) for daily monitoring. Finally, we wanted to determine how patients felt about the home device, as they would be the ones testing themselves daily to enable remote monitoring.

Methods:

Thirty-seven breast cancer patients who underwent surgery, putting them at risk of lymphedema, participated in a study that included five clinic visits and daily monitoring with an at-home BIA device for one year. Participants were asked to test themselves twice daily, Before-Noon and After-Noon. During the first visit, participants were tested using a professional BIA device and the home device they would use for daily testing. A total of 4 study sites in the US were included in the study.

Results:

Participants were categorized according to lymphedema status. The no-lymphedema group, meaning no changes or symptoms were reported at any time, and the subclinical lymphedema (S0) group, which means a change in one of the measurements at some point in time, were grouped as the No-BCRL group, while lymphedema cases (S1) is the BCRL group, with denotes permanent changes in several measurements used to assess lymphedema. Significant differences were found between Before-Noon (BN) and After-Noon (AN) measurements, with BN extracellular water to total body water (ECW/TBW) values higher than AN values. This suggests that a consistent time of day for testing is necessary to track changes in body water components effectively. Additionally, patients tended to test themselves more often in the morning than later in the day. A high intraclass correlation coefficient was found between the outputs of the professional and home BIA devices (the lowest ICC was>.95), indicating the validity of the home device results.

Conclusions:

The home BIA device proved to be a reliable measuring tool when compared to the professional device. Testing time is essential for continuous patient follow-up. The home device proved to be a reliable tool for patient assessment, with which patients also had positive responses to its use. Clinical Trial: N/A