Financial Incentives and Motivational Intervention to Improve Gastric Cancer Screening in China

April 22, 2024 updated by: Li Yang, Peking University

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

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

Interventional

Enrollment (Estimated)

5000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Provision of informed consent by patients;
  2. Identification as "high risk" (≥5 scores) by Gastric Cancer Risk Scoring System (GC-RSS).

Exclusion Criteria:

  1. History of previous gastric cancer screening, including endoscopy and serum biomarker examination (pepsinogen, G-17, and MG7-Ag);
  2. Diagnosis of cancer or presence of precancerous lesions or conditions;
  3. Having family members who have already participated in this study;
  4. Diagnosis of severe depression or psychiatric disorder;
  5. Presence of other medical conditions that preclude receipt of endoscopy services.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Li Yang, PhD, Peking University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 1, 2024

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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