A Multilevel Intervention to Improve Uptake of Gastrointestinal Cancer Screening: a Cluster Randomized Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening, Health education.
- Who it may be relevant to
- Registry conditions: Screening Compliance. Basic parameters: 45 years — 74 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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?
Interventions
- Behavioral Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening
This 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 in - Behavioral Health education
Education Component: 1. Community level: Public awareness campaigns and educational sessions 2. Provider level: Training on screening guidelines and communication skills
Primary outcome measures
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
China · 1 center
- Chongqing University Cancer Hospital — Chongqing
Identifiers
NCT: NCT06830304 · ChongqingCancer_GAS20240407