Precision Navigation to Improve Community Cancer Screening Participation

July 7, 2026 updated by: Hunan Cancer Hospital

Effectiveness and Mechanisms of a Precision Navigation Intervention to Improve Community Cancer Screening Participation: A Dual-Cohort Cluster Randomized Controlled Trial

This study will evaluate whether a precision navigation intervention can help community residents at high risk for cancer complete recommended cancer screening. The study will be conducted in communities participating in an urban cancer screening program in China.

Eligible participants will be adults aged 45 to 74 years who are permanent residents of participating communities and have been identified as being at high risk for at least one of five cancers: lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer. Participants must not have completed the corresponding free clinical screening before enrollment.

This is a dual-cohort, cluster randomized controlled trial. Communities, rather than individual participants, will be assigned to one of three groups: a precision navigation group, a usual health education group, or a waiting control group. Participants will be classified into two cohorts according to the number of cancers for which they are assessed as high risk. Cohort A will include participants at high risk for three or more cancers, and Cohort B will include participants at high risk for one or two cancers.

Participants in the precision navigation group will receive a personalized navigation report matched to their risk profile. The report will explain the screening tests most relevant to them, help them understand screening choices, and provide practical steps to support screening completion. Participants in the usual health education group will receive general cancer screening education materials. Participants in the waiting control group will not receive active screening promotion during the main intervention period, but will receive general education materials after the primary assessment.

The main outcome is whether participants complete the recommended cancer screening during follow-up. The study will also assess changes in screening-related decision conflict, anxiety, self-efficacy, and behavioral intention.

The results may help improve community-based cancer screening programs and provide evidence for using personalized navigation strategies to increase screening participation among high-risk populations.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1500

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 Contact

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:

  1. Aged 45 to 74 years.
  2. Permanent resident of a participating community, defined as having lived in the community for at least 6 months during the past 12 months.
  3. Participating in the urban cancer screening program.
  4. Identified by the program risk assessment questionnaire as being at high risk for at least one of the following cancers: lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer.
  5. Has not yet completed the corresponding free clinical screening test for the high-risk cancer type or types.
  6. Able to complete electronic questionnaires and read intervention materials independently or with assistance. Paper materials and staff explanation will be provided for participants who do not use smartphones.
  7. Able and willing to provide written informed consent.

Exclusion Criteria:

  1. Previously diagnosed with any of the target cancers, including lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, or liver cancer.
  2. Severe cognitive impairment, severe mental illness, or other conditions that prevent the participant from receiving the intervention or completing study questionnaires.
  3. Planning to be away from the community for a long period during the next 6 months, defined as cumulative absence of more than 3 months.
  4. Currently participating in another interventional study that may affect cancer screening behavior.

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
Active Comparator: Usual Health Education Group
Participants in communities assigned to this group will receive general cancer screening health education materials, including information about cancer prevention, early detection, and recommended screening tests.
Behavioral: Usual Health Education
Participants in the usual health education group will receive general cancer screening education materials. The materials will provide basic information about cancer prevention, early detection, and screening for lung cancer, breast cancer, colorectal cancer, upper gastrointestinal cancer, and liver cancer. The content is not personalized according to the participant's individual risk profile.
No Intervention: Waiting Control Group
Participants in communities assigned to this group will not receive active screening promotion during the main intervention period. They will continue to have access to the free cancer screening services provided by the urban cancer screening program. General health education materials will be provided after the primary assessment.
Experimental: Precision Navigation Group
Participants in communities assigned to this group will receive a personalized electronic precision navigation report based on their cancer risk profile. The report will explain the recommended screening tests, support screening decision-making, and provide practical steps to facilitate screening completion.
Behavioral: Precision Navigation Intervention
Participants in the precision navigation group will receive a personalized navigation report based on their cancer risk profile from the urban cancer screening program. The report will be tailored according to whether the participant is at high risk for three or more cancers or for one or two cancers. It will provide individualized information on high-risk cancer types, recommended screening tests, screening procedures, common barriers to screening, and practical action steps. Trained staff will provide a brief standardized explanation of the report and support participants in making a screening action plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Completing Recommended Cancer Screening
Time Frame: From enrollment to 6 months after enrollment
The proportion of enrolled high-risk participants who complete at least one recommended clinical screening test for their corresponding high-risk cancer type or types during follow-up. Screening completion will be determined using records from the urban cancer screening program information system and participating screening institutions.
From enrollment to 6 months after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants Completing All Recommended Cancer Screening Tests
Time Frame: From enrollment to 3 months after enrollment
This outcome is defined as the proportion of participants who complete all cancer screening tests recommended for their individual high-risk cancer profile during follow-up. Screening completion will be determined using records from the urban cancer screening program information system and participating screening institutions.
From enrollment to 3 months after enrollment

Collaborators and Investigators

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

Sponsor

Hunan 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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

June 24, 2026

First Submitted That Met QC Criteria

June 24, 2026

First Posted (Actual)

June 30, 2026

Study Record Updates

Last Update Posted (Actual)

July 8, 2026

Last Update Submitted That Met QC Criteria

July 7, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2026044

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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