Effectiveness of patient-reported outcome-based symptom monitoring after prostate cancer surgery: protocol for a multicenter, randomized controlled trial.

2026-02-21
Trials 27(1)
- Shengping Hu
- Chen Wang
- Tengfei Gu
- Yongtao Pan
- Qinzhou Yu
- Jianguo Gao
- Fusheng Peng
- Ting Chen
- Jie Li

PubMed: 41723520
DOI: 10.1186/s13063-026-09569-8

Study Design

Type: Randomized Controlled Trial (RCT)
Sample size: n = 144
Population: 144 patients with prostate cancer across three hospitals
Methods: multicenter randomized controlled trial; participants randomly assigned in a 1:1 ratio to intervention (PRO-based symptom monitoring with threshold-triggered alerts and clinician responses) or control (standard postoperative care without PRO-triggered alerts); symptom data collected using the M.D. Anderson Symptom Inventory at baseline and on postoperative days 1, 2, 3, 5, 7, 14, 28, 42, and 90
Blinding: Open-label
Duration: 90 days postoperative

Large Human Trial

Introduction

Surgery remains a primary treatment modality for prostate cancer. However, patients often experience a substantial burden of postoperative symptoms, which can significantly delay recovery and negatively impact quality of life. Patient-reported outcome (PRO)-based symptom management has emerged as a promising approach to support patient-centered care. Despite its growing importance, there is a lack of clinical trial evidence evaluating early postoperative symptom management in prostate cancer patients. We propose a multicenter randomized controlled trial to assess the effectiveness of a PRO-based symptom monitoring program with threshold-triggered alerts and clinician responses in promoting postoperative recovery in this population.

Methods

This study will enroll 144 patients with prostate cancer across three hospitals. Participants will be randomly assigned in a 1:1 ratio to either the intervention or control group. The intervention group will receive PRO-based symptom monitoring, whereby specialist clinicians will intervene when scores for target symptoms-pain, fatigue, disturbed sleep, drowsiness, and dry mouth-reach a predefined threshold (score ≥ 4). The control group will receive standard postoperative care without PRO-triggered alerts. Symptom data will be collected using the M.D. Anderson Symptom Inventory at baseline (3 days before surgery) and on postoperative days 1, 2, 3, 5, 7, 14, 28, 42, and 90. The primary outcome-the number of symptom threshold events-will be compared between groups using a t-test.

Discussion

This trial aims to investigate early-phase postoperative symptom management in patients undergoing prostate cancer surgery. Specifically, it will evaluate the efficacy and safety of a WeChat-based symptom management system in postoperative care.

Trials registration

This trial was registered in the Chinese Clinical Trial Registry (ChiCTR2400082090) on 20 March 2024, and the registration details are available at https://www.chictr.org.cn/showproj.html?proj=214038.