Construction and clinical validation of a multidimensional stratified management path based on dynamic patient-reported outcomes (PROs) in cancer pain management: study protocol for a randomised controlled trial.

Abstract

Pain is one of the most prevalent symptoms among patients with cancer, and its presence and severity provide important prognostic information regarding survival. Patients with cancer pain experience a decline in their overall quality of life, along with a corresponding reduction in physical, cognitive, emotional and social functioning. Symptom management based on dynamic patient-reported outcomes (PROs) is recognised as the optimal 'patient - centered' healthcare model. However, clinical trial evidence on symptom management for patients with cancer pain remains insufficient. Therefore, we plan to conduct a randomised controlled trial to evaluate the effect of a PRO-based symptom monitoring response programme on pain intervention in patients with cancer in pain. This study will recruit 116 patients with cancer in pain from our hospital. They will be randomly assigned in a 1:1 ratio to either the intervention group or the control group. When a patient in the intervention group reports target symptoms (pain Numerical Rating Scale (NRS) >3, emotional screening Patient Health Questionnaire-4 Score >5 or nutritional screening NRS2002 Score ≥3), they will receive stratified symptom management based on PROs. A specialist physician will make adjustments according to symptom severity. Patients in the control group will not trigger alerts and will continue to follow the standard symptom management process. All patients will undergo a baseline assessment on the day of enrolment. The control group will receive routine outpatient management, and follow-ups will be conducted via telephone or online at 1 week, 2 weeks and 1 month after discharge. All patients will be followed up until 3 months after enrolment, disease progression, achievement of a pain-free state or death, whichever occurs first. The primary outcome measure-the effective rate of pain control-will be statistically analysed to compare differences between the intervention and control groups. This study was approved by the Ethics Committee of Chengdu BOE Hospital on 14 August 2025 (approval No.: 2025052) and subsequently amended on 14 January 2026 (approval No.: 2026006). The manuscript is based on V.2.0 of the study protocol dated 14 January 2026. The study results will be disseminated in peer-reviewed journals and presentations at academic conferences. ChiCTR2500114591.