Prospective surveillance for breast cancer-related lymphedema (PROTECT)

Abstract

Breast cancer-related lymphedema (BCRL) is a progressive condition caused by damage to the lymphatic system [Citation1] and affects one in three patients following axillary lymph node dissection [Citation2]. The early phase of BCRL involves accumulation of extracellular fluid without fibrosis (subclinical), that later progress to irreversible intradermal fibrosis (chronic)[Citation3]. Risk factors for BCRL include obesity and body weight gain [Citation4,Citation5]. It can be associated with feeling of heaviness, inferior quality of life and emotional distress [Citation6] and when chronic require continuous treatment with compression garments [Citation7–9]. Clinical guidelines [Citation10–14] recognize the importance of early detection and management of BCRL to allow simpler treatment and better clinical outcomes and highlight the need for research into development and testing of programs that enable surveillance of survivors at-risk [Citation13–15]. However, in Denmark there is no national streamlined approach for measurement and management of BCRL likely due to paucity of research evidence into effective, scalable, and accessible surveillance programs.

Prospective surveillance and early management (PS) programs are suggested to improve early detection and treatment of BCRL and prevent progression of the condition [Citation16]. Such programs include pre-surgery and ongoing post-surgery assessments to detect BCRL and if detected, to provide early treatment [Citation17,Citation18]. Two small trials (total n = 106) suggest a preventative effect of PS programs versus usual care (relative risk 0.31; 95%CI 0.10 to 0.95) [Citation16] and a larger trial suggest that PS using bioimpedance spectroscopy (BIS) is ideal to allow early detection of BCRL [Citation19], however, robust controlled trials are needed to confirm the effect [Citation16].

To date, all research has focused on PS programs delivered as hospital-based surveillance afforded by therapists. However, such programs risk increasing the inequity of health among survivors. It is therefore important to ensure that patients with a wide representation of education levels, income, living arrangements and comorbidity can access and participate in PS programs. Furthermore, the main barriers for implementing this approach in publicly funded healthcare are access to trained healthcare professionals, access to sophisticated measurement tools to identify BCRL, and the associated cost of long-term surveillance for a large at-risk population. These barriers highlight the need to consider other delivery strategies, such as a self-management approach, to increase the reach and equity of access to surveillance programs.

To improve reach and lower the costs of PS programs, we developed self-management BCRL surveillance resources [Citation20], demonstrated them to be feasible and acceptable to include in hospital-based programs [Citation21] and able to support survivors in performing measurements of own arm circumference at home in a reliable and valid manner [Citation20,Citation21]. These resources include a brief video to allow people to learn to perform self-measurements of arm circumference along with an inexpensive tape measure that allows for hand-free measurements.

This trial examines if a self-managed PS program reduce the prevalence of chronic BCRL compared to usual care. The purpose of this manuscript is two-fold, namely, to report: a) the trial protocol; and b) preliminary feasibility data.