A Multilevel Intervention to Improve Uptake of Gastrointestinal Cancer Screening: a Cluster Randomized Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 15,000
- Locations
- 1
- Primary Endpoint
- Endoscopy Appointment Rate
Study Overview
Brief 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. 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 45 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •high-risk individuals of gastrointestinal cancer in 45-74 years old
Exclusion Criteria
- •Unable to give consent
- •history of cancer
- •severe cardiac, pulmonary, brain, or renal dysfunction or any other serious disease
- •psychiatric illness
- •pregnancy
Arms & Interventions
Control Arm
Intervention Group 1
Communities assigned to this arm will receive intervention including basic health education.
Intervention: Health education (Behavioral)
Intervention Group2
Communities assigned to this arm will receive comprehensive multi-level interventions including health education and patient navigation services....
Intervention: Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening (Behavioral)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported