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

February 11, 2025 updated by: Chongqing University Cancer Hospital

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 Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400030
        • Chongqing University Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Arm
Experimental: Intervention Group 1
Communities assigned to this arm will receive intervention including basic health education.
Behavioral: Health education

Education Component:

  1. Community level: Public awareness campaigns and educational sessions
  2. Provider level: Training on screening guidelines and communication skills
Experimental: Intervention Group2
Communities assigned to this arm will receive comprehensive multi-level interventions including health education and patient navigation services....
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 including:

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endoscopy Appointment Rate
Time Frame: From enrollment to appointment 90 days
From enrollment to appointment 90 days
Endoscopy Completion Rate
Time Frame: From enrollment to appointment Endoscopy Completion 90 days
From enrollment to appointment Endoscopy Completion 90 days
Time to Endoscopy Completion
Time Frame: Time interval between endoscopy appointment scheduling and completion of colonoscopy.
Time interval between endoscopy appointment scheduling and completion of colonoscopy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chongqing University Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2024

Primary Completion (Estimated)

March 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

February 11, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ChongqingCancer_GAS20240407

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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