To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD)
A Multi-center Randomized Control Single Cross-over Study to Evaluate the Safety and Effectiveness of Dayspring Active Wearable Compression Device vs. an Advanced Pneumatic Compression Device for Treating Breast Cancer Related Lymphedema. To evaluate the Dayspring Active Wearable Compression Device in contrast to an advanced pneumatic compression device (APCD) in a multi-centered setting to evaluate volume, quality of life, safety, adherence, and preference.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Cross over arms after a month of use and a month of washout period
PT works
Los Altos, California, United States
Ginger-K Lymphedema & Cancer Center
Morgan Hill, California, United States
Arm Volume Maintenance or Improvement
Limb volume measurement is performed by using a calibrated tape measure to measure circumference from the wrist and the ulnar styloid process and at 4cm increments to the axilla. Measurements to be taken for both upper extremities. Volume is calculated based on cylindrical segment analysis. The outcome measure is assessed as a difference or change from baseline to month 1
Time frame: 1 month
LYMQOL (LYMphedema Quality of Life)
The Lymphedema Quality of Life Questionnaire (LYMQOL), a validated disease-specific QoL tool, is also administered at baseline and month 1. Overall QoL is scored on a single item by the patient on a scale of 1-10. The outcome measure is assessed as a difference or change from baseline LYMQOL at day zero and month 1
Time frame: 1 month
Safety/AEs
As assessed by reported adverse events
Time frame: 1 month
Therapy adherence tracking
A table will be provided to patient to document days of use with the device to track adherence
Time frame: 1 month
Patient survey on preference
A study survey administered at the end of the study to measure patient preference between the two devices
Time frame: 1 month
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