Electra D Paskett1, Jennifer Le-Rademacher2, Jill M Oliveri3, Heshan Liu2, Drew K Seisler2, Jeffrey A Sloan2, Jane M Armer4, Michelle J Naughton1, Karen Hock5, Michael Schwartz6, Gary Unzeitig7, Marianne Melnik8, Lisa D Yee9, Gini F Fleming10, John R Taylor11, Charles Loprinzi12. 1. The Ohio State University Comprehensive Cancer Center, Division of Cancer Prevention and Control, Department of Internal Medicine, College of Medicine, Columbus, Ohio. 2. Department of Health Sciences Research, Alliance Statistics and Data Center, Mayo Clinic, Rochester, Minnesota. 3. The Ohio State University Comprehensive Cancer Center, Population Sciences, Columbus, Ohio. 4. University of Missouri Sinclair School of Nursing, Columbia, Missouri. 5. The Ohio State University Comprehensive Cancer Center, Stefanie Spielman Comprehensive Breast Center Oncology Rehabilitation, Columbus, Ohio. 6. Department of Medicine, Division of Medical Oncology and Hematology, Mount Sinai Medical Center, Miami Beach, Florida. 7. Doctors Hospital of Laredo, Laredo, Texas. 8. Department of General Surgery, Division of Surgical Oncology and Breast Care Services, Spectrum Health, Grand Rapids, Michigan. 9. Division of Surgical Oncology, City of Hope, Duarte, California. 10. Department of Medicine, Section of Hematology/Oncology, University of Chicago Comprehensive Cancer Center, Chicago, Illinois. 11. Biological Sciences Division, The University of Chicago, Alliance Protocol Operations Program Office, Chicago, Illinois. 12. Department of Medical Oncology, Mayo Clinic, Rochester, Minnesota.
Abstract
BACKGROUND: Lymphedema affects many women who are treated for breast cancer. We examined the effectiveness of an education-only (EO) versus education plus sleeve compression/exercise intervention (lymphedema education and prevention [LEAP]) on lymphedema incidence and range of motion (ROM) in a group-randomized trial across 38 cooperative group sites. METHODS: The treating institution was randomly assigned to either EO or LEAP by a study statistician. All patients at a treating institution participated in the same intervention (EO or LEAP) to minimize contamination bias. Participants completed surveys, arm volume measurements, and self-reported ROM assessments before surgery and at 12 and 18 months after surgery. Lymphedema was defined as a ≥10% difference in limb volume at any time post-surgery up to 18 months after surgery or diagnosis by a health provider. Cochran-Mantel-Haenszel tests were used to compare lymphedema-free rates between groups, stratified by lymph node surgery type. Self-reported ROM differences were compared between groups. RESULTS: A total of 554 participants (56% LEAP) were included in the analyses. At 18 months, lymphedema-free rates were 58% (EO) versus 55% (LEAP) (P = .37). ROM for both arms was greater in LEAP versus EO at 12 months; by 18 months, most women reported full ROM, regardless of group. In LEAP, only one-third wore a sleeve ≥75% of the time; 50% performed lymphedema exercises at least weekly. CONCLUSION: Lymphedema incidence did not differ by intervention group at 18 months. Poor adherence in the LEAP group may have contributed. However, physical therapy may speed recovery of ROM. Further research is needed to effectively reduce the incidence and severity of lymphedema in patients who have breast cancer.
BACKGROUND: Lymphedema affects many women who are treated for breast cancer. We examined the effectiveness of an education-only (EO) versus education plus sleeve compression/exercise intervention (lymphedema education and prevention [LEAP]) on lymphedema incidence and range of motion (ROM) in a group-randomized trial across 38 cooperative group sites. METHODS: The treating institution was randomly assigned to either EO or LEAP by a study statistician. All patients at a treating institution participated in the same intervention (EO or LEAP) to minimize contamination bias. Participants completed surveys, arm volume measurements, and self-reported ROM assessments before surgery and at 12 and 18 months after surgery. Lymphedema was defined as a ≥10% difference in limb volume at any time post-surgery up to 18 months after surgery or diagnosis by a health provider. Cochran-Mantel-Haenszel tests were used to compare lymphedema-free rates between groups, stratified by lymph node surgery type. Self-reported ROM differences were compared between groups. RESULTS: A total of 554 participants (56% LEAP) were included in the analyses. At 18 months, lymphedema-free rates were 58% (EO) versus 55% (LEAP) (P = .37). ROM for both arms was greater in LEAP versus EO at 12 months; by 18 months, most women reported full ROM, regardless of group. In LEAP, only one-third wore a sleeve ≥75% of the time; 50% performed lymphedema exercises at least weekly. CONCLUSION: Lymphedema incidence did not differ by intervention group at 18 months. Poor adherence in the LEAP group may have contributed. However, physical therapy may speed recovery of ROM. Further research is needed to effectively reduce the incidence and severity of lymphedema in patients who have breast cancer.
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