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Increasing Breast and Colorectal Cancer Screening in the Community

12 de agosto de 2026 actualizado por: Christina Wang, Icahn School of Medicine at Mount Sinai

A Pilot Trial of a Community-Based Strategy to Improve Colorectal and Breast Cancer Screening

The goal of the proposed study is to conduct a pilot randomized controlled trial (RCT) of Chi gung, a community-based intervention using peer education and tailored navigation to simultaneously improve colorectal (CRC) and breast cancer (BC) screening rates.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

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

Copia de seguridad de contactos de estudio

  • Nombre: Lili Liang
  • Número de teléfono: 347-270-7705
  • Correo electrónico: lili.liang@mssm.edu

Ubicaciones de estudio

  • Estados Unidos
    • New York
      • New York, New York, Estados Unidos, 10029
        • The Icahn School of Medicine at Mount Sinai
        • Investigador principal:
          • Christina Wang
        • Contacto:
        • Contacto:
      • New York, New York, Estados Unidos, 10002
        • Henry Street Settlement
        • Contacto:
      • New York, New York, Estados Unidos, 10002
      • New York, New York, Estados Unidos, 10013
        • Charles B. Wang Community Health Center
        • Contacto:
      • New York, New York, Estados Unidos, 10013
        • VNS Health Chinatown Community Center
        • Contacto:
      • New York, New York, Estados Unidos, 10038
        • St. Margaret's House
        • Contacto:
      • New York, New York, Estados Unidos, 11223
        • United Chinese Association of Brooklyn
        • Contacto:
          • Ansen Tang
          • Número de teléfono: 929-715-5276
          • Correo electrónico: M.tang@ucaob.org

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:

  • Age 45-75 years old
  • Self-identify as Chinese and born outside of the U.S.
  • Speaks Mandarin, Cantonese, or English
  • Not up to date on BC screening (i.e., have not had a mammogram within the past two years)

  • Not up to date on CRC screening (i.e., have not had any of the following tests)

    • Colonoscopy within the past 10 years
    • Fecal immunochemical tests/fecal occult blood tests within the past year or multi-target stool DNA test within the past three years
    • Flexible sigmoidoscopy within the past 5 years
    • CT colonography within the past 5 years

Exclusion Criteria:

  • Life expectancy ≤ 10 years or other pre-existing conditions whereby CRC or BC screening would not be recommended
  • Personal history of BC or CRC
  • Prior history of a total colectomy or mastectomy
  • Lacks capacity to provide informed consent

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Chi gung: Stay Well, Live Well
Chi gung: Stay Well, Live Well is a community-based intervention using peer education and tailored navigation
Conductual: Chi gung: Stay Well, Live Well
The intervention consists of a A) 90-minute group education session led by a community health worker (CHW) that 1) addresses CRC and BC incidence, mortality, development, symptoms, and screening tests, in addition to shared beliefs and common obstacles to CRC and BC screening, 2) involves experiential education (e.g., demonstrations of stool based testing and colonoscopy bowel preparation), 3) question and answer session, and 4) take-home materials summarizing CRC and BC screening information and local resources; and B) peer navigation assistance by telephone to address ongoing obstacles to CRC and BC screening completion, conducted over a 6 month period.
Conductual: Chi gung: Stay Well, Live Well
The attention control arm will receive a A) time-matched (90-minute) general health didactic on risk factors for cancer and take-home materials on concepts discussed, and B) telephone calls to address concepts covered in the presentation (number of calls will be based on the average frequency of peer navigation calls in the intervention arm).
Comparador activo: Attention Control (AC) Arm
This time-matched and attention control group will receive a general health group education session and follow-up telephone calls.
Conductual: Chi gung: Stay Well, Live Well
The intervention consists of a A) 90-minute group education session led by a community health worker (CHW) that 1) addresses CRC and BC incidence, mortality, development, symptoms, and screening tests, in addition to shared beliefs and common obstacles to CRC and BC screening, 2) involves experiential education (e.g., demonstrations of stool based testing and colonoscopy bowel preparation), 3) question and answer session, and 4) take-home materials summarizing CRC and BC screening information and local resources; and B) peer navigation assistance by telephone to address ongoing obstacles to CRC and BC screening completion, conducted over a 6 month period.
Conductual: Chi gung: Stay Well, Live Well
The attention control arm will receive a A) time-matched (90-minute) general health didactic on risk factors for cancer and take-home materials on concepts discussed, and B) telephone calls to address concepts covered in the presentation (number of calls will be based on the average frequency of peer navigation calls in the intervention arm).

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Intervention Acceptability Score
Periodo de tiempo: 6 Months
This will measure whether the participants will accept the intervention. Acceptability will be measured through surveys (likert-rated items) and open-ended questions (semi-structured interviews). The minimum score is 6 and the maximum score is 42; higher scores indicate the intervention is acceptable.
6 Months
Number of Navigation Calls
Periodo de tiempo: 6 Months
This will measure how well the participants can be navigated through the healthcare system and connected to resources using this intervention. Integration will be measured through review of navigation call logs and will include number of navigation calls completed per participant, number of self-reported healthcare visits by the participant, and open-ended questions (semi-structured interviews).
6 Months
Intervention Adaptation Score
Periodo de tiempo: Baseline, Immediately Post-Education Session, 6 Months
This will measure how well the intervention was adapted to address colorectal cancer (CRC) and breast cancer (BC) screening beliefs, benefits, barriers, and self-efficacy. Adaptation will be measured through surveys (likert-rated) and open-ended questions (semi-structured interviews). These measures are investigator-developed subscales informed by the literature. On the beliefs subscale, the minimum score is 17 and the maximum score is 85; higher scores indicate more favorable screening beliefs. On the benefits subscale, the minimum score is 3 and the maximum score is 15; on the barriers subscale, the minimum score is 5 and the maximum score is 25. Higher scores indicate greater perceived benefits and greater perceived barriers, respectively. On the self-efficacy subscale, the minimum score is 8 and the maximum score is 40; higher scores indicate greater self-efficacy to complete screening.
Baseline, Immediately Post-Education Session, 6 Months
The Proportion of Participants Who Have Completed Recommended Screening Tests.
Periodo de tiempo: 6 Months
The proportion of participants who have completed recommended CRC and BC screening tests to assess intervention efficacy.
6 Months

Colaboradores e Investigadores

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

Patrocinador

Icahn School of Medicine at Mount Sinai

Colaboradores

National Cancer Institute (NCI)

Investigadores

  • Investigador principal: Christina Wang, MD, Icahn School of Medicine at Mount Sinai

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 (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de diciembre de 2028

Finalización del estudio (Estimado)

1 de marzo de 2029

Fechas de registro del estudio

Enviado por primera vez

31 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

31 de julio de 2026

Publicado por primera vez (Actual)

5 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de agosto de 2026

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

12 de agosto de 2026

Última verificación

1 de agosto de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY-23-01343
  • K08CA283362 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Marco de tiempo para compartir IPD

Immediately following publication. No end date.

Criterios de acceso compartido de IPD

Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Specify Other Mechanism. De-identified public-use data files will be deposited in a data repository and accessible to researchers who agree to the repository's Terms of Use. Restricted-use data files will be available upon execution of a Data Use Agreement approved by the Icahn School of Medicine at Mount Sinai; requests should be directed to the Principal Investigator.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF

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

producto fabricado y exportado desde los 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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