NCT06830304

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?

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 16, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 17, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

February 17, 2025

Status Verified

November 1, 2024

Enrollment Period

12 months

First QC Date

February 11, 2025

Last Update Submit

February 11, 2025

Conditions

Screening Compliance

Outcome Measures

Primary Outcomes (3)

  • Endoscopy Appointment Rate

    From enrollment to appointment 90 days

  • Endoscopy Completion Rate

    From enrollment to appointment Endoscopy Completion 90 days

  • Time to Endoscopy Completion

    Time interval between endoscopy appointment scheduling and completion of colonoscopy.

Study Arms (3)

Control Arm

NO INTERVENTION

Intervention Group 1

EXPERIMENTAL

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

Behavioral: Health education

Intervention Group2

EXPERIMENTAL

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

Interventions

Multi-level Education and Navigation Program for Gastrointestinal Cancer ScreeningBEHAVIORAL

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 Group2
Health educationBEHAVIORAL

Education Component: 1. Community level: Public awareness campaigns and educational sessions 2. Provider level: Training on screening guidelines and communication skills

Intervention Group 1

Eligibility Criteria

Age45 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • high-risk individuals of gastrointestinal cancer in 45-74 years old

You may not qualify if:

  • Unable to give consent
  • history of cancer
  • severe cardiac, pulmonary, brain, or renal dysfunction or any other serious disease
  • psychiatric illness
  • pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 11, 2025

First Posted

February 17, 2025

Study Start

April 16, 2024

Primary Completion

March 30, 2025

Study Completion

June 30, 2025

Last Updated

February 17, 2025

Record last verified: 2024-11

Locations

CN(1)