P1.068. Design Features of PRO-Based Remote Symptom Monitoring Interventions With Alert-Triggered Clinical Response in Cancer RCTs: A Systematic Review

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ID: 326077
2026
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Abstract
Abstract Topic Esophageal Cancer: Surgical Treatment of Esophageal Cancer – early outcomes and complications Background Patient-reported outcome (PRO)-based remote symptom monitoring with alert-triggered clinical response improves survival and quality of life in cancer patients. However, the design features constituting these complex interventions remain poorly characterised, limiting replication and optimisation. We conducted a systematic review to characterise the methodological architecture of such interventions across five analytical domains: PRO instruments, monitoring platforms, alert thresholds, clinical response protocols, and patient-facing feedback systems. Methods We searched PubMed/MEDLINE, Embase, Cochrane Library, Web of Science, CINAHL (inception to October 21, 2025), and ClinicalTrials.gov using terms spanning PROs, remote monitoring, cancer, and randomised design. Eligible studies were randomised controlled trials (RCTs) evaluating systematic PRO-based symptom monitoring with an alert or clinical response mechanism in cancer populations. Three reviewers independently screened records and extracted data using a 75-variable framework. Descriptive synthesis was employed. The protocol is registered with PROSPERO. Results From 1,689 records, 67 publications representing 61 unique RCTs (25,795 patients; 18 countries) and 6 registered protocols were included. Over 20 PRO instruments were identified; NCI PRO-CTCAE was most common (19.7%). Smartphone applications were the predominant platform (31.1%); EHR integration was achieved in only 21.3%. Alert systems were present in 93.4%, but tiered architectures were used in only 23.0%. Standardised response protocols existed in 73.8%, yet response timeliness was reported in only 62.3%, and no trial documented a validated triage tool. Reporting completeness was not associated with trial outcome (OR 1.05, 95% CI 0.63–1.74). Analysis of six null-result trials identified four mechanistic failure archetypes: context mismatch, response pathway failure, outcome measure mismatch, and temporal/power limitations. Conclusion PRO-based remote symptom monitoring in cancer exhibits substantial methodological heterogeneity across all five design domains. Critical reporting gaps—particularly monitoring adherence (21.3%), response timeliness (62.3%), and escalation documentation (0%)—obscure the active ingredients of interventions known to improve survival. Standardised reporting is urgently needed. The 25 candidate reporting items proposed here provide a foundation for structured international consensus development, with the goal of enabling replication, comparison, and optimisation of these potentially life-saving interventions.
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Authors Simiao Lu, Yi Zhu, Yongtao Han, Qiuling Shi, Xuefeng Leng
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Journal diseases of the esophagus : official journal of the international society for diseases of the esophagus
Year 2026
DOI
10.1093/dote/doag077.216
URL
https://academic.oup.com/dote/article-pdf/39/Supplement_1/doag077.216/70761310/doag077.216.pdf
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