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

NCT ID: NCT06830304

Last Updated: 2025-02-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 15000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-16
• Study Completion Date: 2025-06-30

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?

Conditions

Screening Compliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Control Arm

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group 1

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

Group Type: EXPERIMENTAL

Health education

Intervention Type: BEHAVIORAL

Education Component:

1. Community level: Public awareness campaigns and educational sessions

2. Provider level: Training on screening guidelines and communication skills

Intervention Group2

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

Group Type: EXPERIMENTAL

Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening

Intervention Type: BEHAVIORAL

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 including:

Appointment scheduling assistance Transportation coordination Insurance/financial counseling Reminder calls/messages Social/psychological support

Interventions

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 including:

Appointment scheduling assistance Transportation coordination Insurance/financial counseling Reminder calls/messages Social/psychological support

Intervention Type: BEHAVIORAL

Health education

Education Component:

1. Community level: Public awareness campaigns and educational sessions

2. Provider level: Training on screening guidelines and communication skills

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chongqing University Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Countries

China

Other Identifiers

ChongqingCancer_GAS20240407

Identifier Type: -

Identifier Source: org_study_id