ePRO-Guided Symptom Management In Breast Cancer Adjuvant Radiotherapy: A Prospective Controlled Study

Summary

This prospective controlled study evaluated an ePRO-guided symptom management pathway during breast cancer adjuvant radiotherapy. Compared with usual care, the intervention reduced acute symptom burden, improved recovery trajectories, and preserved quality of life through automated alerts and nurse-led stratified interventions.

Abstract

Postoperative adjuvant radiotherapy for breast cancer is frequently associated with acute treatment-related symptoms that negatively affect quality of life (QoL). This prospective controlled study evaluated the efficacy of an electronic patient-reported outcome (ePRO)-guided symptom management pathway integrated into routine radiotherapy care. A total of 117 patients were enrolled, and 105 completed radiotherapy and were included in the final analysis (usual care, n = 52; usual care plus ePRO-guided management, n = 53). The primary endpoint was the longitudinal trajectory of acute symptom burden, while the secondary endpoint was change in QoL during treatment. Validated symptom and QoL instruments were administered longitudinally, and outcomes were analyzed using linear mixed-effects models adjusted for prespecified baseline covariates. Compared with usual care, the ePRO-guided group demonstrated significantly lower peak symptom severity, faster symptom recovery toward the end of treatment, and more favorable longitudinal trends in global and breast cancer-specific QoL domains (all P < 0.05). The ePRO-guided pathway integrated weekly monitoring, automated alert generation, and nurse-led stratified interventions into a closed-loop management workflow. These findings suggest that integrating ePRO-triggered symptom management into routine radiotherapy practice may reduce acute symptom burden and support patient-centered care during breast cancer radiotherapy.

Introduction

Breast cancer is one of the most common malignancies among women worldwide, and its global incidence continues to rise¹. With the widespread implementation of screening programs and continuous advances in multidisciplinary treatment, an increasing number of patients are entering long-term survivorship². Consequently, clinical attention has shifted beyond survival outcomes toward comprehensive survivorship care, including symptom burden management and preservation of quality of life (QoL)³. Postoperative adjuvant radiotherapy remains a cornerstone of breast cancer treatment for reducing local recur....

Protocol

The study was conducted in accordance with the ethical principles of the Declaration of Helsinki. The study protocol, including the ePRO-based symptom monitoring workflow and patient confidentiality safeguards, was reviewed and approved by the Ethics Committee of Shandong Second Medical University for Human Life Science and Medical Research Approval (IRB No. 2026YX173). Written informed consent was obtained from all participants before enrollment. All electronic patient-reported outcome data were collected, transmitted, and stored through a secure, encrypted, and access-controlled institutional platform to protect patient privacy and confidentiality. The research tool....

Results

Baseline characteristics

Table 1 summarizes the baseline demographic and clinical characteristics of the study population. Overall, the cohort consisted predominantly of middle-aged women, with closely matched age and body mass index (BMI) distributions between groups, indicating balanced baseline demographics. No significant intergroup differences were observed in menopausal status, educational level, marital status, employment status, or urban versus

Discussion

This study focused on the critical treatment window of postoperative adjuvant radiotherapy, a period characterized by high curative potential but substantial acute symptom burden. The findings suggest that the incorporation of a patient-reported outcome (PRO)-guided symptom management pathway into routine radiotherapy care enabled earlier and more consistent capture of patient-reported experiences throughout treatment. This approach facilitated more timely stratified responses to high-frequency symptoms, including skin-r.......

Materials

List of materials used in this article

Name	Company	Catalog Number	Comments
Clinical Toxicity Grading	National Cancer Institute (NCI)	CTCAE v5.0	Used by clinicians to assess adverse events (e.g., dermatitis, pain)
CTCAE Grading System	National Cancer Institute (NCI)	Version 5.0	Clinician-rated toxicity grading
Electronic Patient-Reported Outcome (ePRO) System	Custom-developed / Shandong Second Medical University	N/A	Web-based or mobile platform for weekly symptom self-assessment; integrated with alert system
EORTC QLQ-BR23	European Organisation for Research and Treatment of Cancer (EORTC)	N/A	Breast cancer-specific module used alongside QLQ-C30
EORTC QLQ-C30	European Organisation for Research and Treatment of Cancer (EORTC)	Version 3.0	Standardized cancer-specific quality of life questionnaire
EORTC Scoring Manual	European Organisation for Research and Treatment of Cancer	Current edition	Standardized QoL score transformation
Image-Guided Radiotherapy (IGRT) Devices	Varian Medical Systems	On-Board Imager (OBI) and Cone Beam CT	Daily imaging for patient positioning verification
Patient-Reported Adverse Event (PRAE) Scale	Adapted from validated PRO instruments	N/A	Used to assess symptom frequency, severity, and impact; includes domains: skin, pain, fatigue, sleep, emotional distress
PRO-CTCAE Item Library	National Cancer Institute (NCI)	Current release	Symptom item framework for patient-reported toxicity assessment
R Statistical Software	R Foundation for Statistical Computing	Version 4.X.X	Linear mixed-effects modeling and longitudinal analysis
Radiotherapy Planning Systems	Varian Medical Systems	Eclipse Treatment Planning System	IMRT/VMAT planning tools (inferred from technique description)
SPSS Statistics	IBM Corp.	Version 2X.0	Statistical analysis software