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Precision Navigation to Improve Community Cancer Screening Participation

15 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Tipo de estudio

Intervencionista

Inscripción (Estimado)

1500

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Ubicaciones de estudio

    • Hunan
      • Huaihua, Hunan, Porcelana
        • Reclutamiento
        • Huaihua Central Hospital (Huaihua Cancer Hospital)
        • Contacto:
          • Qiang Yan
          • Número de teléfono: 8615111549588
          • Correo electrónico: 383114173@qq.com
      • Shaoyang, Hunan, Porcelana
        • Reclutamiento
        • Shaoyang Hospital of Traditional Chinese Medicine
        • Contacto:
          • Liping Deng
          • Número de teléfono: 8618473926876
      • Yongzhou, Hunan, Porcelana
        • Reclutamiento
        • Yongzhou Central Hospital
        • Contacto:
          • Suzhen He
          • Número de teléfono: 8613974618396
          • Correo electrónico: 25187557@qq.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

Sí

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Poner en pantalla
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: 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.
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.
Sin intervención: 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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of Participants Completing Recommended Cancer Screening
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of Participants Completing All Recommended Cancer Screening Tests
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

4 de agosto de 2026

Finalización primaria (Estimado)

30 de marzo de 2027

Finalización del estudio (Estimado)

1 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

24 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de junio de 2026

Publicado por primera vez (Actual)

30 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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