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
7 affiliations
- 1Department of Social Medicine and Health Management, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China
- 2NHC Key Lab of Health Economics and Policy Research (Shandong University), Jinan, China
- 3Center for Health Management and Policy Research, Shandong University (Shandong Provincial Key New Think Tank), Jinan, China
- 4Shandong Provincial Third Hospital, Cheeloo College of Medicine, Shandong University, Jinan, China
- 5Department of Epidemiology, School of Public Health, Cheeloo College of Medicine, Shandong University, Jinan, Shandong, China
- 6Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences, Jinan, China
- 7China National Health Development Research Center, Beijing, China
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.
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BibTeX
@article{liu2026implementing,
title = {{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}},
author = {Ruyue Liu and Chao Zheng and Liyu Wang and Nan Zhang and Qiang Sun},
journal = {BMJ Open},
year = {2026},
month = sep,
doi = {10.1136/bmjopen-2026-116321},
url = {https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-116321},
note = {CC BY-NC 4.0},
}
RIS
TY - JOUR
TI - 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
AU - Ruyue Liu
AU - Chao Zheng
AU - Liyu Wang
AU - Nan Zhang
AU - Qiang Sun
PY - 2026
DA - 2026/09/30
JO - BMJ Open
DO - 10.1136/bmjopen-2026-116321
UR - https://bmjopen.bmj.com/lookup/doi/10.1136/bmjopen-2026-116321
AB - 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.
SN - 2044-6055
SN - 2044-6055
ER -