Background: Breast cancer-related lymphedema (BCRL) is a common and debilitating treatment-related adverse event that can profoundly impact quality of life and financial well-being. Although prospective surveillance and early intervention for BCRL have been shown to reduce the incidence and severity of this chronic condition, diagnostic accuracy of screening, programmatic utilization and efficacy vary widely. We describe the protocol for the BCRL Prospective Surveillance Model (PSM) and Early Intervention Program at the Dana-Farber Brigham Cancer Center that aims to address these issues by augmenting arm measurements (standard of care) with use of patient-reported outcome metrics (PROMs). Methods: Women with newly diagnosed stage I-III breast cancer at high risk for developing BCRL based on tumor and treatment characteristics are eligible for inclusion in our PSM care pathway, which uses both the Breast Cancer and Lymphedema Symptom Experience Index PROMs and arm measurements for screening. Screening begins prior to the initiation of neoadjuvant therapy and continues at regular intervals postoperatively. A positive screen, defined as new patient-reported arm swelling/heaviness and/or relative volume change (RVC) ≥ 5% in the affected limb, triggers consideration for multidisciplinary early intervention. Analysis: The BCRL detection rate will be compared to years previous to protocol development. PSM feasibility will be determined according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Efficacy of the PSM will be gauged by comparing change in patient-reported outcomes of interest and arm volume measurement pre and post early intervention. Feasibility will be determined by calculating the percentage of PSM-eligible individuals who complete all PSM activities in a 1-year span. Characteristics of participants versus non-participants in the target population will be compared. Furthermore, 1:1 semi-structured interviews with enrolled patients will be performed to understand facilitators and barriers to implementation. Conclusions: The findings from this study will be used to develop a standardized approach to PSM and early intervention that can be adapted to both resource-modest and resource-abundant healthcare infrastructures.
Keywords: breast cancer; clinical protocol; lymphedema; patient-reported outcome measures; quality of life.