Predictors of Lymphedema Following Breast Cancer Surgery
The purpose of this study evaluate which factors play a role in lymphedema development among women who have had axillary surgery for breast cancer. Potential risk factors for women who have developed lymphedema will be compared to risk factors among women who have not developed lymphedema after breast cancer surgery.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Predictors of Lymphedema Following Breast Cancer Surgery|
|Study Start Date:||January 2003|
|Study Completion Date:||May 2008|
|Primary Completion Date:||May 2008 (Final data collection date for primary outcome measure)|
Patients with lymphedema
Identification of risk factors for lymphedema in women who have had axillary surgery for breast cancer.
Control patients without lymphedema
Controls matched on type of axillary surgery and surgery date for comparison in quality of life (QOL) ratings from women who have lymphedema.
Surgery for breast cancer includes removal of the breast tumor along with the axillary lymph nodes. The status of these nodes helps clinicians determine prognosis and guides treatment decisions. Unfortunately, a relatively common side effect following axillary lymph node dissection is upper-extremity lymphedema. The purpose of this study is to identify risk factors for lymphedema among women who have had axillary surgery for breast cancer. Specific aims include identifying risk factors for lymphedema and comparing quality of life (QOL) ratings for women who have and do not have lymphedema. A case-control study will be conducted with enrollment of 200 participants. Cases will be identified at their lymphedema consult in the physical therapy centers. Using the oncology registry, controls will include patients who have had breast cancer surgery and have not developed lymphedema. The severity of lymphedema and interference with daily life will be assessed with the Measure of Arm Symptom Survey (MASS), a patient-completed survey, and QOL will be collected with the SF-36. Treatment risk factors including previous surgery, radiotherapy and chemotherapy will be obtained from oncology registry data. This study will determine which factors play a role in lymphedema development.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00202046
|United States, Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|North Memorial Medical Center|
|Minneapolis, Minnesota, United States, 55422|
|Park Nicollet Institute|
|St. Louis Park, Minnesota, United States, 55416|
|Principal Investigator:||Karen K Swenson, RN, MS, PhDc||Park Nicollet Institute|