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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Precision Navigation Group | Experimental | 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. |
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| Usual Health Education Group | Active Comparator | 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. |
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| Waiting Control Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Precision Navigation Intervention | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Completing Recommended Cancer Screening | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Completing All Recommended Cancer Screening Tests | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haifan Xiao | Contact | 8615580869827 | xiaohaifan@hnca.org.cn |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| Usual Health Education | Behavioral | 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. |
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| From enrollment to 3 months after enrollment |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D008107 | Liver Diseases |