PATIENT-REPORTED OUTCOMES-BASED SYMPTOM MONITORING AMONG PATIENTS RECEIVING IMMUNOTHERAPY FOR LUNG CANCER: A RANDOMIZED CONTROLLED TRIAL
Author(s)
Yiqi Xia1, Ping He, Doctor2;
1Beijing, China, 2Peking University, Beijing, China
1Beijing, China, 2Peking University, Beijing, China
OBJECTIVES: Electronic patient-reported outcomes (ePROs) have shown potential to improve symptom monitoring and patient-centered care in oncology. However, evidence from randomized controlled trials (RCTs) in patients receiving immunotherapy, particularly regarding health-related quality of life (HRQoL), remains limited in China. This study aims to evaluate the impact of a 6-month ePRO-based intervention on HRQoL, physical and mental functioning, and healthcare resource use among patients with lung cancer receiving immunotherapy.
METHODS: This study is an ongoing RCT that will end in July 2026, and this paper reports the study design and results by January 2026. Participants were recruited from hospitals across seven provinces in China and randomized to an ePRO-based intervention group or a usual care control group. HRQoL was assessed using the EORTC QLQ-C30 at baseline, 3- and 6-months. Linear mixed-effects models were used to estimate mean differences in HRQoL domains from baseline between groups, adjusting for age, sex, education, and occupation. Clinically meaningful change was further evaluated using responder analyses based on minimal important differences (MID) of 5 and 10 points.
RESULTS: A total of 174 participants (89 intervention, 85 control) completed baseline and at least one follow-up assessment. No significant between-group differences were observed for HRQoL. Significant improvements were observed in role functioning, social functioning, cognitive functioning, and overall physical functioning, and global health status at one or both follow-up time points. Responder analyses showed that a higher proportion of patients in the intervention group experienced clinically meaningful improvement (MID ≥5) and fewer experienced worsening in overall HRQoL at both 3 months (P=0.01) and 6 months (P=0.005) compared with controls.
CONCLUSIONS: These findings show potential of effectiveness of preventing the disease from deterioration, and provide a robust foundation for subsequent longitudinal analyses of the effects of the ePRO-based intervention on HRQoL, symptom trajectories, mental health outcomes, and healthcare use.
METHODS: This study is an ongoing RCT that will end in July 2026, and this paper reports the study design and results by January 2026. Participants were recruited from hospitals across seven provinces in China and randomized to an ePRO-based intervention group or a usual care control group. HRQoL was assessed using the EORTC QLQ-C30 at baseline, 3- and 6-months. Linear mixed-effects models were used to estimate mean differences in HRQoL domains from baseline between groups, adjusting for age, sex, education, and occupation. Clinically meaningful change was further evaluated using responder analyses based on minimal important differences (MID) of 5 and 10 points.
RESULTS: A total of 174 participants (89 intervention, 85 control) completed baseline and at least one follow-up assessment. No significant between-group differences were observed for HRQoL. Significant improvements were observed in role functioning, social functioning, cognitive functioning, and overall physical functioning, and global health status at one or both follow-up time points. Responder analyses showed that a higher proportion of patients in the intervention group experienced clinically meaningful improvement (MID ≥5) and fewer experienced worsening in overall HRQoL at both 3 months (P=0.01) and 6 months (P=0.005) compared with controls.
CONCLUSIONS: These findings show potential of effectiveness of preventing the disease from deterioration, and provide a robust foundation for subsequent longitudinal analyses of the effects of the ePRO-based intervention on HRQoL, symptom trajectories, mental health outcomes, and healthcare use.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
PCR60
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
SDC: Oncology