Gastric CancerNCT06384300
Financial Incentives and Motivational Intervention to Improve Gastric Cancer Screening in China
A study testing Financial Incentives, Motivational Intervention and Mixed Intervention in people with Gastric Cancer, run by Peking University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- Financial Incentives, Motivational Intervention and Mixed Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provision of informed consent by patients;
- Identification as "high risk" (≥5 scores) by Gastric Cancer Risk Scoring System (GC-RSS).
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Gastric Cancer
- Being tested
- Financial Incentives, Motivational Intervention, Mixed Intervention
- Keywords
- Gastric Cancer, Screening, Random Control Trial, China
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial IncentivesOther
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.
Motivational InterventionOther
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.
Mixed InterventionOther
Participants in the mixed intervention group will receive both financial incentives and motivational intervention.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | This is the control group. |
| Group B | Experimental | 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. Receives: Other: Financial Incentives |
| Group C | Experimental | 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. Receives: Other: Motivational Intervention |
| Group D | Experimental | Participants in the mixed intervention group (Group D) will receive both financial incentives and motivational intervention. Receives: Other: Mixed Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome 1
Our primary outcome is the rate of individuals undergoing endoscopy screening within three months.
Measured: 3 month (90 days)
Primary Outcome 2
Our primary outcome is the rate of individuals undergoing endoscopy screening within six months.
Measured: 6 month (180 days)
Secondary outcomes (1)
Secondary Outcome
the proportion of participants adhering to follow-up endoscopy appointments at one- or two-years post-intervention
Measured: 1 or 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Aug 2024 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Yang, Peking University
- Investigators
- Li Yang, PhD, Study director, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384300
- Sponsor's protocol ID
- BMSF
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Incentives and Motivational Intervention to Improve Gastric Cancer Screening in China: An Individual Level Randomized Controlled Trial Study Protocol
- ClinicalTrials.gov ID
- NCT06384300
- Acronym / sponsor ID
- BMSF
- Conditions
- Gastric Cancer
- Keywords
- Gastric Cancer, Screening, Random Control Trial, China
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Aug 2024 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –This is the control group. |
| Group B | Experimental | Other: Financial IncentivesIn 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. |
| Group C | Experimental | Other: Motivational InterventionFor 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. |
| Group D | Experimental | Other: Mixed InterventionParticipants in the mixed intervention group (Group D) will receive both financial incentives and motivational intervention. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Provision of informed consent by patients;
- Identification as "high risk" (≥5 scores) by Gastric Cancer Risk Scoring System (GC-RSS).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial IncentivesIn 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. | Other | Group B |
| Motivational InterventionFor 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. | Other | Group C |
| Mixed InterventionParticipants in the mixed intervention group will receive both financial incentives and motivational intervention. | Other | Group D |
Primary outcome
Primary Outcome 1
Time frame: 3 month (90 days)
Our primary outcome is the rate of individuals undergoing endoscopy screening within three months.
Primary Outcome 2
Time frame: 6 month (180 days)
Our primary outcome is the rate of individuals undergoing endoscopy screening within six months.
1 secondary outcome
Secondary Outcome
Time frame: 1 or 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Yang, PhD study director
Peking University
Questions about this trial
What is this clinical trial studying?
A study testing Financial Incentives, Motivational Intervention and Mixed Intervention in people with Gastric Cancer, run by Peking University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Li Yang, PhD (+86 13681173906, lyang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome 1 (time frame: 3 month (90 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.