A Multilevel Intervention to Improve Uptake of Gastrointestinal Cancer Screening: a Cluster Randomized Clinical Trial

Chongqing University Cancer Hospital

Status: Invitation-only

Conditions: Screening Compliance

Treatments: Behavioral: Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening; Behavioral: Health education

Study type: Interventional

Funder types: Other

Identifiers

NCT06830304

ChongqingCancer_GAS20240407

Details and patient eligibility

About

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?

Enrollment: 15,000 estimated patients

Sex: All

Ages: 45 to 74 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15,000 participants in 3 patient groups

Control Arm

No Intervention group

Intervention Group 1

Experimental group

Description:

Communities assigned to this arm will receive intervention including basic health education.

Treatment:

Behavioral: Health education

Intervention Group2

Experimental group

Description:

Communities assigned to this arm will receive comprehensive multi-level interventions including health education and patient navigation services....

Treatment:

Behavioral: Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening