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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06830304
Enrollment
15000
Registered
2025-02-17
Start date
2024-04-16
Completion date
2025-06-30
Last updated
2025-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Screening Compliance

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?

Interventions

BEHAVIORALMulti-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

BEHAVIORALHealth education

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

Sponsors

Chongqing University Cancer Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 74 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Endoscopy Appointment RateFrom enrollment to appointment 90 days
Endoscopy Completion RateFrom enrollment to appointment Endoscopy Completion 90 days
Time to Endoscopy CompletionTime interval between endoscopy appointment scheduling and completion of colonoscopy.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026