A Web-and-Mobile-Based Intervention for Women Treated for Breast Cancer to Manage Chronic Pain and Symptoms Related to Lymphedema: Results of a Randomized Clinical Trial (Preprint)

BACKGROUND The-Optimal-Lymph-Flow is a patient-centered, web-and-mobile-based mHealth system that delivers safe, easy and feasible digital therapy of lymphatic exercises and limb mobility exercises. The purpose of this randomized clinical trial (RCT) was to evaluate the effectiveness of the web-and-mobile-based The-Optimal-Lymph-Flow system for managing chronic pain and symptoms related to lymphedema. OBJECTIVE The primary objective of this study was to determine the effectiveness of the web-and-mobile-based The-Optimal-Lymph-Flow system for managing chronic pain, aching, soreness, and tenderness among breast cancer survivors and quality of life related to pain. The secondary objective was to evaluate the effectiveness of the web-and-mobile-based The-Optimal-Lymph-Flow system for managing symptoms related to lymph fluid accumulation, limb volume differences, and body mass index (BMI). METHODS A parallel randomized controlled trial (RCT) with a control-experimental, pre- and post-test, repeated-measures design. A total of 120 patients were recruited and randomized according to pain with 1:1 ratio into either Arm Precaution (AP) control focusing on limb mobility and protection or The-Optimal-Lymph flow (TOLF) intervention focusing promoting lymph flow and limb mobility. Trial outcomes were evaluated at baseline and week 12 post intervention. Descriptive statistics, Fisher’s Exact tests, Wilcoxon rank-sum tests, t-test, and generalized linear mixed-effects models were performed for data analysis. RESULTS At the study endpoint of week 12 post intervention, significantly fewer patients in the TOLF intervention group compared to AP control group reported chronic pain (49% vs. 71%; OR=0.39, CI=[0.17, 0.90], p=0.021). Patients in TOLF intervention group were significantly more likely to experience a complete reduction in chronic pain (50% vs 22%; OR=3.56, CI = [1.39, 9.76], p=0.005), and soreness (43% vs 22%; OR=2.60, CI = [1.03, 6.81], p=0.034). Significantly lower median severity scores were found in TOLF group for chronic pain (〖Med〗_LE=0, IQR=0-1 vs 〖Med〗_AP=1, IQR=0-2; p=0.024) and general bodily pain (〖Med〗_LE=1, IQR=0-1.5 vs 〖Med〗_AP=1, IQR=1-3; p=0.040). Compared to AP control, significantly fewer patients in TOLF group reported arm/hand swelling (p=0.038); heaviness (p=0.027), redness (p=0.033), limited movement in shoulder (p=0.015) and arm (p=0,025). No significant differences between TOLF and AP groups were found in complete reduction of aching and tenderness, mean numbers of lymphedema symptom reported, > 5% limb volume differences, and BMI. CONCLUSIONS TOLF intervention had significant benefits for breast cancer survivors to manage chronic pain, soreness, general bodily pain, limb swelling, heaviness, and impaired limb mobility. TOLF intervention resulted in a 13% reduction in proportions of patients who took pain medications compared to AP group which had a 5% increase. A 12% reduction in proportions of patients with > 5% limb volume differences were found in the TOLF group while a 5% increase in the AP group. Taking together, TOLF intervention can be a better choice for breast cancer survivors to reduce chronic pain and limb volume. CLINICALTRIAL US Clinicaltrials.gov NCT02462226, https://clinicaltrials.gov/ct2/show/NCT02462226