Assessments
LSIDS-A, chronic edema, arm lymphedema, bodily pain, BCRL
ADVERSE EVENTS, LYMPHEDEMA, EVENT, ADVERSE EVENT
Participants completed study visits at screening, baseline, device training (within 21 days after the baseline visit), and at 30-day and 60-day follow-ups. Device training was conducted by qualified Tactile Medical personnel.The primary endpoint was to compare the rate of treatment compliance in patients in the test group with those in the control group. Complete compliance was defined as an average of 5–7 treatments per week, partial compliance as 1–4 treatments per week, and noncompliance as <1 treatment per week.Exploratory endpoints included assessments of arm girth, quality of life (QOL), symptom questionnaires, and adverse events. Participants were provided with a tape measure to make arm girth measurements on the anterior forearm 6 cm below the midline of the antecubital fossa on the affected arm.Disease-specific quality of life was measured using the Lymphedema Quality of Life Tool (LYMQOL ARM). The LYMQOL ARM is a 21-item questionnaire designed and validated in patients with chronic edema. The survey includes 4 domains: function, appearance, symptoms, and mood, and an overall QOL score. Each domain item is scored on a 4-point scale with higher scores indicating worse QOL. The overall QOL score is scored from 0 (poor) to 10 (excellent) [Symptom severity was assessed using the Lymphedema Symptom Intensity and Distress Survey-Arm (LSIDS-A). The LSIDS-A is a 30-item validated assessment tool designed for measuring arm lymphedema and its associated symptoms in patients with BCRL [General quality of life was assessed using the validated RAND Short Form-36 (SF-36). The SF-36 evaluates 8 domains: general health, physical functioning, physical role limitations, emotional role limitations, energy/fatigue, emotional well-being, social functioning, and bodily pain [Adverse events were categorized as serious or nonserious with severity rankings of mild, moderate, or severe. The relationship of the event to the device was rated as not related, possibly, probably, or definitely related.