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BACKGROUND - The purpose of this study was to conduct a preliminary, post-market, home study of the Flexitouch(®) system to examine the potential efficacy of the device as a component of self-care in breast cancer survivors with truncal lymphedema.
METHODS AND RESULTS - A quasi-experimental, pre-treatment, post-treatment design was used. Twelve participants received a total of ten self-administered, consecutive, one hour per day treatments. Treatments one and two were observed by study staff and the remaining eight were unobserved. Assessments were conducted at baseline, after the first two treatments, mid-way through therapy, and at the end-of-study. Logs revealed 100% compliance with the eight prescribed unobserved home treatments. Symptoms were assessed by self-report symptom surveys. Signs, objectively observed physical phenomenon, were assessed by staff-initiated skin examination and circumferential truncal measurements. Statistically significant improvement in truncal symptoms and sleep were found. Changes in function and girth were not statistically significant in this initial study.
CONCLUSIONS - Breast cancer survivors with truncal lymphedema may benefit from using an advanced pneumatic compression devices with truncal treatment as part of their self-care program. Participants were highly compliant in device use. Further research of this intervention is warranted. To facilitate future research, clinically meaningful reductions in truncal girth should be defined.