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Enrolling by Invitation

NCT Number: NCT06830304

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

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?

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Key information

Conditions

Screening Compliance

Age range

45 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, 400030, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening

Behavioral

This multi-level intervention consists of two major components implemented at community, healthcare provider, and individual levels:

Education Component:

  • Community level: Public awareness campaigns and educational sessions
  • Provider level: Training on screening guidelines and communication skills
  • Individual level: Tailored educational materials and one-on-one counseling

Navigation Component:

  • Patient needs assessment and barrier identification
  • Personalized navigation services including:

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

Health Education

Behavioral

Education Component:

  • Community level: Public awareness campaigns and educational sessions
  • Provider level: Training on screening guidelines and communication skills

Primary outcomes

  1. Endoscopy Appointment Rate

    Time frame: From enrollment to appointment 90 days

  2. Endoscopy Completion Rate

    Time frame: From enrollment to appointment Endoscopy Completion 90 days

  3. Time to Endoscopy Completion

    Time frame: Time interval between endoscopy appointment scheduling and completion of colonoscopy.

Sponsors and collaborators

Lead sponsor

Chongqing University Cancer Hospital

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 17, 2025
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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