Study design and population
cancer, PCD, infection, acute venous disease, BCRL
CANCER, HEART FAILURE, INFECTION, INFLAMMATORY DISEASE
The study was an on-label, prospective, randomized, 2-group feasibility study conducted at 2 centers. Ethics approval was received through Western IRB (Puyallup, WA) and University of Louisville Human Subjects Protection Program Office (Louisville, KY). The study is registered at Participants were females of 18 years or older with unilateral BCRL who provided informed consent, agreed to comply with the study requirements, and were able to receive text messages from the study sponsor. Participants were excluded from participation if they had used a PCD in the previous 3 months, had undergone phase 1 complete decompression therapy (CDT) within 1 month or were planning to undergo during the study period, were currently undergoing curative cancer therapy, or were unable to be fitted for PCD garments. Additional medical conditions excluding participants were heart failure, acute venous disease, active skin or limb infection or inflammatory disease, pregnancy or planning to become pregnant, and any condition where increased lymphatic or venous return was undesirable. Lastly, participants were excluded if there was a known inability to receive cell phone connection where the PCD therapy was to be administered.After signing the informed consent and inclusion/exclusion criteria were confirmed, participants were randomized by an electronic data capture database to either PCD therapy with connectivity (test) or PCD therapy without connectivity (control). The randomization scheme was generated by a statistician using a permutated block design with block size balanced within each block to maintain a 1:1 ratio between treatment groups.PCD therapy was conducted using the Flexitouch® (FT) Plus advanced PCD (Tactile Medical, Minneapolis, MN, USA) in daily 60-min U1 unilateral sessions at normal pressure. The devices used for the study were identical to the commercially available devices except for a cellular communication module that was added to the controller unit, which transmitted usage data to a cloud-based database. This usage information was used to send automated text message reminders to participants in the test group if they had not used the device for 2 consecutive days. Participants in the control group did not receive text message reminders.