Implementing a medical opinion leader-led management model to promote timely treatment initiation among screen-positive patients with upper gastrointestinal cancer in rural China: a cluster randomised controlled trial protocol.
This protocol describes a 16-hospital cluster-randomised trial in rural China testing whether medical opinion leader-led WeChat education and face-to-face consultation increase treatment initiation within 30 days among at least 372 adults with screen-detected upper gastrointestinal cancer.
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This protocol describes a 16-hospital cluster-randomised trial in rural China testing whether medical opinion leader-led WeChat education and face-to-face consultation increase treatment initiation within 30 days among at least 372 adults with screen-detected upper gastrointestinal cancer.
Research significance
The record establishes only a planned evaluation; it is hypothesised that opinion leader-led education and consultation will reduce care-navigation delays and increase timely treatment initiation, but no efficacy, safety, survival, or pediatric outcomes are yet reported.
Source abstract
INTRODUCTION: Upper gastrointestinal cancer (UGC), including oesophageal and gastric cancers, imposes a substantial health burden, particularly in China. Timely treatment after a positive screening result is critical, as treatment delays may contribute to disease progression and poorer outcomes. This study aims to evaluate the effectiveness of a management model led by medical opinion leaders (MOLs) in shortening the time to treatment initiation among screen-positive patients with UGC. METHODS AND ANALYSIS: This multicentre, cluster randomised controlled trial will be conducted at 16 secondary hospitals in Shandong province, China. The participating hospitals will be randomly assigned to the intervention or control group in a 1:1 ratio. Screen-positive patients aged 18-80 years whose UGC diagnosis is confirmed by endoscopy and pathological examination will be recruited. At least 372 participants will be enrolled. The intervention group will receive an MOL-led management intervention comprising WeChat-based health education and face-to-face consultations. The primary outcome is the 30-day timely treatment rate, defined as the proportion of participants who initiate treatment within 30 days after pathological diagnosis. Secondary outcomes are the cumulative treatment initiation rates within 60, 90 and 180 days. Baseline information will be collected at enrolment, and treatment status will be assessed at 30, 60, 90 and 180 days. ETHICS AND DISSEMINATION: The study protocol was reviewed and approved by the Science and Technology Ethics Committee of the School of Public Health, Shandong University (No. STEC-SPH-SDU-20250703). Written informed consent will be obtained from all participants. The study findings will be disseminated through publications in peer-reviewed journals, presentations at national and international academic conferences and communication with participating medical institutions and study participants. TRIAL REGISTRATION NUMBER: ChiCTR2500109389.