180
Participants
Start Date
January 22, 2020
Primary Completion Date
January 31, 2026
Study Completion Date
January 31, 2026
Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction
Current standard treatment at Memorial Sloan Kettering \[MSK\]).
quality-of-life questionnaires
Four validated patient reported outcome measures (PROMs): the Upper Limb Lymphedema-27 (ULL-27), the Quality of Life Measure for Limb Lymphedema (LYMQOL), the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Anxiety Inventory (BAI). Study participants will undergo standard lymphedema measurements and quality-of-life questionnaires at baseline before ALND and postoperatively at 6 weeks (+/- 30 days) and at 6, 12, 18, and 24 months (+/- 30 days). If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them.
measured by arm volume
Bilateral arm volumes will be measured with sequential circumferential measurements with the truncated cone formula. If a patient cannot return to Manhattan for these assessments but is seen by a lymphedema therapist in a regional location or at an institution outside of MSK as part of their routine cancer treatment, this data can be used in the final analysis
Memorial Sloan Kettering Cancer Center, New York
Memorial Sloan Kettering Westchester (Consent Only), Harrison
Memorial Sloan Kettering Nassau (Consent only), Uniondale
Memorial Sloan Kettering Commack (Consent only), Commack
Memorial Sloan Kettering Basking Ridge (Consent and Followup), Basking Ridge
Memorial Sloan Kettering Monmouth (Consent Only), Middletown
Memorial Sloan Kettering Bergen (Consent Only), Montvale
Memorial Sloan Kettering Cancer Center
OTHER