Screening ComplianceNCT06830304
A Multilevel Intervention to Improve Uptake of Gastrointestinal Cancer Screening: a Cluster Randomized Clinical Trial
A study testing Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening and Health education in people with Screening Compliance, run by Chongqing University Cancer Hospital at 1 site in China.
Trial summary
This study is a cluster randomized controlled trial aimed at evaluating the effectiveness of a multi-level intervention strategy in improving adherence to gastrointestinal cancer screening. Communities will be randomly assigned as the unit of randomization to either intervention or control group. Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Screening Compliance
- What is being tested?
- Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening and Health education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,000 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2024to 30 Jun 2025
- 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 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- high-risk individuals of gastrointestinal cancer in 45-74 years old
Who cannot join
- Unable to give consent
- history of cancer
- severe cardiac, pulmonary, brain, or renal dysfunction or any other serious disease
- psychiatric illness
- pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
About this study
This study is a cluster randomized controlled trial aimed at evaluating the effectiveness of a multi-level intervention strategy in improving adherence to gastrointestinal cancer screening. Communities will be randomly assigned as the unit of randomization to either intervention or control group. The study population includes community residents aged 50-74 years. Communities in the intervention group will receive multi-level interventions including health education, patient navigation services, and appointment assistance, while communities in the control group will maintain routine screening management. All participants will be followed up for 90 days to track their endoscopy appointment and completion rates. The main research question is:
Can community-based multi-level intervention effectively improve adherence to gastrointestinal cancer screening among community residents?
- Conditions
- Screening Compliance
- Being tested
- Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening, Health education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-level Education and Navigation Program for Gastrointestinal Cancer ScreeningBehavioural
This multi-level intervention consists of two major components implemented at community, healthcare provider, and individual levels:
Education Component:
- Community level: Public awareness campaigns and educational sessions
- Provider level: Training on screening guidelines and communication skills
- Individual level: Tailored educational materials and one-on-one counseling
Navigation Component:
- Patient needs assessment and barrier identification
- Personalized navigation services including:
Appointment scheduling assistance Transportation coordination Insurance/financial counseling Reminder calls/messages Social/psychological support
Health educationBehavioural
Education Component:
- Community level: Public awareness campaigns and educational sessions
- Provider level: Training on screening guidelines and communication skills
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | No intervention | Not described |
| Intervention Group 1 | Experimental | Communities assigned to this arm will receive intervention including basic health education. Receives: Behavioral: Health education |
| Intervention Group2 | Experimental | Communities assigned to this arm will receive comprehensive multi-level interventions including health education and patient navigation services.... Receives: Behavioral: Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopy Appointment Rate
Measured: From enrollment to appointment 90 days
Endoscopy Completion Rate
Measured: From enrollment to appointment Endoscopy Completion 90 days
Time to Endoscopy Completion
Measured: Time interval between endoscopy appointment scheduling and completion of colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start16 Apr 2024
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Screening ComplianceStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing University Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06830304
- Sponsor's protocol ID
- ChongqingCancer_GAS20240407
- Status last verified
- Nov 2024
- First submitted
- 11 Feb 2025
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multilevel Intervention to Improve Uptake of Gastrointestinal Cancer Screening: a Cluster Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06830304
- Acronym / sponsor ID
- ChongqingCancer_GAS20240407
- Conditions
- Screening Compliance
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Chongqing University Cancer HospitalUniversity, hospital or other
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 17 Feb 2025 (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.
This study is a cluster randomized controlled trial aimed at evaluating the effectiveness of a multi-level intervention strategy in improving adherence to gastrointestinal cancer screening. Communities will be randomly assigned as the unit of randomization to either intervention or control group. The study population includes community residents aged 50-74 years. Communities in the intervention group will receive multi-level interventions including health education, patient navigation services, and appointment assistance, while communities in the control group will maintain routine screening management. All participants will be followed up for 90 days to track their endoscopy appointment and completion rates. The main research question is:
Can community-based multi-level intervention effectively improve adherence to gastrointestinal cancer screening among community residents?
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Arm | No intervention | – |
| Intervention Group 1 | Experimental | Behavioral: Health educationCommunities assigned to this arm will receive intervention including basic health education. |
| Intervention Group2 | Experimental | Behavioral: Multi-level Education and Navigation Program for Gastrointestinal Cancer ScreeningCommunities assigned to this arm will receive comprehensive multi-level interventions including health education and patient navigation services.... |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- high-risk individuals of gastrointestinal cancer in 45-74 years old
Key exclusion criteria (5 listed)
- Unable to give consent
- history of cancer
- severe cardiac, pulmonary, brain, or renal dysfunction or any other serious disease
- psychiatric illness
- pregnancy
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 |
|---|---|---|
| Multi-level Education and Navigation Program for Gastrointestinal Cancer ScreeningThis multi-level intervention consists of two major components implemented at community, healthcare provider, and individual levels: Education Component: 1. Community level: Public awareness campaigns and educational sessions 2. Provider level: Training on screening guidelines and communication skills 3. Individual level: Tailored educational materials and one-on-one counseling Navigation Component: 1. Patient needs assessment and barrier identification 2. Personalized navigation services including: Appointment scheduling assistance Transportation coordination Insurance/financial counseling Reminder calls/messages Social/psychological support | Behavioural | Intervention Group2 |
| Health educationEducation Component: 1. Community level: Public awareness campaigns and educational sessions 2. Provider level: Training on screening guidelines and communication skills | Behavioural | Intervention Group 1 |
Primary outcome
Endoscopy Appointment Rate
Time frame: From enrollment to appointment 90 days
Endoscopy Completion Rate
Time frame: From enrollment to appointment Endoscopy Completion 90 days
Time to Endoscopy Completion
Time frame: Time interval between endoscopy appointment scheduling and completion of colonoscopy.
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 17 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening and Health education in people with Screening Compliance, run by Chongqing University Cancer Hospital at 1 site in China.
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 1 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: enrolling by invitation, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopy Appointment Rate (time frame: From enrollment to appointment 90 days). The study lists 3 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 17 Feb 2025.