- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06384300
Financial Incentives and Motivational Intervention to Improve Gastric Cancer Screening in China
Financial Incentives and Motivational Intervention to Improve Gastric Cancer Screening in China: An Individual Level Randomized Controlled Trial Study Protocol
Gastric cancer, also known as stomach cancer, is a serious disease that affects the stomach. It's one of the most common types of cancer, and sadly, many people die from it each year. But there's hope! We can catch gastric cancer early with a special test called endoscopy. This test helps doctors find cancer or pre-cancerous changes in the stomach early, when it's easier to treat. However, not enough people get this test, especially in places where healthcare isn't easily available. That's why we're doing this study.
We want to find out if we can encourage more people to get the endoscopy test for gastric cancer. We're going to try two different ways to encourage people to get the test. First, we'll give some people money or other incentives to help cover the costs of getting the test. Second, we'll give others information and support to help them understand why the test is important and how it can help them.
We'll be doing this study in two provinces in China, where gastric cancer is a big problem. We'll ask thousands of people to join the study, and we'll randomly assign them to one of the two groups. Then, we'll see if more people in one group get the endoscopy test compared to the other group.
Our hope is that by finding out what works best, we can help more people catch gastric cancer early and get the treatment they need. This could save many lives and make a big difference in fighting this disease.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Gastric cancer (GC) remains a significant global health challenge, with high mortality rates, particularly in low- and middle-income country, like China. Early detection through screening is crucial for improving prognosis and reducing mortality. However, uptake of GC screening remains suboptimal, highlighting the need for effective interventions to promote screening participation.
This study employs an experimental design to evaluate the effectiveness of two interventions, financial incentives and motivational interventions, in promoting GC screening uptake at the individual level. A large sample size will be recruited from high GC-burden provinces in China, and participants will be randomly assigned to intervention and control groups. Statistical analyses, including Propensity Score Matching and Interrupted Time Series Analysis, will be utilized to assess the impact of interventions on screening uptake and adherence.
Findings from this study will be disseminated through peer-reviewed publications, conference presentations, and engagement with stakeholders to inform evidence-based strategies for improving GC screening and reducing GC-related morbidity and mortality.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Li Yang, PhD
- Phone Number: +86 13681173906
- Email: lyang@bjmu.edu.cn
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Provision of informed consent by patients;
- Identification as "high risk" (≥5 scores) by Gastric Cancer Risk Scoring System (GC-RSS).
Exclusion Criteria:
- History of previous gastric cancer screening, including endoscopy and serum biomarker examination (pepsinogen, G-17, and MG7-Ag);
- Diagnosis of cancer or presence of precancerous lesions or conditions;
- Having family members who have already participated in this study;
- Diagnosis of severe depression or psychiatric disorder;
- Presence of other medical conditions that preclude receipt of endoscopy services.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Group A
This is the control group.
|
|
|
Experimental: Group B
In the financial incentive group (Group B), participants will receive reimbursement for transportation, accommodation, and food costs, along with RMB 200 (about 30 US dollar) to compensate for potential income loss due to endoscopy, provided they undergo the procedure.
|
In the financial incentive group, participants will receive reimbursement for transportation, accommodation, and food costs, along with RMB 200 (about 30 US dollar) to compensate for potential income loss due to endoscopy, provided they undergo the endoscopy.
|
|
Experimental: Group C
For the motivational intervention group (Group C), researchers will provide detailed information about the social norms surrounding endoscopy screening, including the prevalence of screening participation, the potential risks of gastric cancer, and the health benefits of screening.
|
For the motivational intervention group, researchers will provide detailed information about the social norms surrounding endoscopy screening, including the prevalence of screening participation, the potential risks of gastric cancer, and the health benefits of screening.
|
|
Experimental: Group D
Participants in the mixed intervention group (Group D) will receive both financial incentives and motivational intervention.
|
Participants in the mixed intervention group will receive both financial incentives and motivational intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Primary Outcome 1
Time Frame: 3 month (90 days)
|
Our primary outcome is the rate of individuals undergoing endoscopy screening within three months.
|
3 month (90 days)
|
|
Primary Outcome 2
Time Frame: 6 month (180 days)
|
Our primary outcome is the rate of individuals undergoing endoscopy screening within six months.
|
6 month (180 days)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Secondary Outcome
Time Frame: 1 or 2 years
|
the proportion of participants adhering to follow-up endoscopy appointments at one- or two-years post-intervention
|
1 or 2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Li Yang, PhD, Peking University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BMSF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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