Interactive Computer Program or Brochure in Increasing Colorectal Cancer Screening Among African Americans (PACT)
16 de agosto de 2013 actualizado por: Indiana University
Promoting Colon Cancer Screening Among African Americans
RATIONALE: An interactive computer program may be more effective than a brochure in increasing colorectal cancer screening among African Americans.
PURPOSE: This randomized clinical trial is studying an interactive computer program to see how well it works compared with a brochure in increasing colorectal cancer screening among African Americans.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
OBJECTIVES:
- Compare rates of participation in fecal occult blood testing and endoscopic screening (colonoscopy or sigmoidoscopy) among African-Americans who receive an interactive computer intervention (ICI) versus a non-tailored colorectal cancer screening brochure.
- Examine mediators and moderators of intervention effectiveness as depicted in the conceptual model.
OUTLINE: This is a multicenter study.
Participants are stratified according to site, age (≤ 65 years old vs > 65 years old) and gender. Participants are randomized to one of two arms.
- Arm I (non-tailored colorectal cancer screening brochure): Participants undergo a baseline interview via telephone and receive a colorectal cancer screening brochure in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.
- Arm II (interactive computer intervention [ICI]): Participants undergo a baseline interview via telephone and complete an ICI in the clinic prior to visit with healthcare provider. Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.
Tipo de estudio
Intervencionista
Inscripción (Actual)
693
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.
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Nursing
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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
51 años a 80 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
DISEASE CHARACTERISTICS:
- Currently being seen in the primary care clinics of Wishard Memorial Hospital (Indianapolis, IN), Roudebush Veterans Affairs Medical Center (Indianapolis, IN), IU Health Family Medicine Center (Indianapolis, IN) or Norton Louisville Primary Care Clinic (Louisville, KY)
African-American who is currently non-adherent to screening guidelines, meeting all of the following criteria:
- No fecal occult blood test in the past 12 months
- No sigmoidoscopy in the past 5 years
- No colonoscopy in the past 10 years
- Patients with average and increased risk for colorectal cancer are eligible
- No personal history of colorectal cancer
PATIENT CHARACTERISTICS:
- Participants must have a telephone
- English-speaking
- Able to read at a 5th grade reading level
- No medical condition that prohibits colorectal cancer screening
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: Non-tailored CRC screening brochure
Participants undergo a baseline interview via telephone and receive a non-tailored CRC screening brochure in the clinic prior to visit with healthcare provider.
Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.
|
Patients receive written educational material about colorectal cancer and prompting to talk to their doctor about getting tested.
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Experimental: Interactive computer intervention
Participants undergo a baseline interview via telephone and complete an interactive computer intervention in the clinic prior to visit with healthcare provider.
Participants then undergo telephone interviews at 1 week, 6 months, and 15 months.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Self-reported colorectal cancer (CRC) screening adherence with medical record verification of screening test completion
Periodo de tiempo: 6 and 15 months post-intervention
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6 and 15 months post-intervention
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Self-reported CRC discussion and screening test recommendation from provider on intervention/clinic visit date
Periodo de tiempo: 1 week post-intervention
|
Discussion of Fecal Occult Blood Test (FOBT), colonoscopy, and sigmoidoscopy is assessed.
Participants report on whether or not an FOBT kit was given to them during this visit.
Additionally, participants report on whether or not someone in the doctor's office made an appointment for a colonoscopy or sigmoidoscopy.
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1 week post-intervention
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Provider documentation of CRC discussion and screening test recommendation on intervention/clinic visit date
Periodo de tiempo: 1 week post-intervention
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Medical record documentation of discussion of FOBT, providing participant with an FOBT kit, discussion and/or ordering a colonoscopy, and discussion and/or ordering a sigmoidoscopy is assessed.
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1 week post-intervention
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Self-reported CRC health beliefs
Periodo de tiempo: Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention
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Changes in perceived risk, benefits to screening, barriers to screening, and self-efficacy for CRC screening are assessed.
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Pre-intervention (baseline),1 week post-intervention, and 6 months post-intervention
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Self-reported stage of CRC screening test adoption
Periodo de tiempo: Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
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For FOBT, colonoscopy, and sigmoidoscopy, stage of adoption measured as either precontemplation, contemplation, preparation, action, or maintenance.
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Pre-intervention (baseline),1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient characteristics as CRC screening predictors
Periodo de tiempo: Pre-intervention (baseline), intervention date, 1 week post-intervention, 6 months post-intervention, and/or 15 months post-intervention
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Age, gender, marital status, education, health literacy, income, employment, insurance coverage, BMI, co-morbidities, family history of cancer, family or friend encouragement to have CRC screening, CRC knowledge, physician trust, fatalism views, and health temporal orientation are assessed.
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Pre-intervention (baseline), intervention date, 1 week post-intervention, 6 months post-intervention, and/or 15 months post-intervention
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Clinic variables as CRC screening predictors
Periodo de tiempo: Pre-intervention (baseline), 1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
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Clinic site, participant's reason for health care provider visit, and prior recommendation(s) to do CRC screening are assessed.
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Pre-intervention (baseline), 1 week post-intervention, 6 months post-intervention, and 15 months post-intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Susan Rawl, PhD, RN, Indiana University School of Medicine
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Rawl SM, Christy SM, Perkins SM, Tong Y, Krier C, Wang HL, Huang AM, Laury E, Rhyant B, Lloyd F, Willis DR, Imperiale TF, Myers LJ, Springston J, Skinner CS, Champion VL. Computer-tailored intervention increases colorectal cancer screening among low-income African Americans in primary care: Results of a randomized trial. Prev Med. 2021 Apr;145:106449. doi: 10.1016/j.ypmed.2021.106449. Epub 2021 Feb 4.
- Christy SM, Perkins SM, Tong Y, Krier C, Champion VL, Skinner CS, Springston JK, Imperiale TF, Rawl SM. Promoting colorectal cancer screening discussion: a randomized controlled trial. Am J Prev Med. 2013 Apr;44(4):325-329. doi: 10.1016/j.amepre.2012.11.032.
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
1 de enero de 2008
Finalización primaria (Actual)
1 de abril de 2012
Finalización del estudio (Actual)
1 de abril de 2012
Fechas de registro del estudio
Enviado por primera vez
3 de mayo de 2008
Primero enviado que cumplió con los criterios de control de calidad
3 de mayo de 2008
Publicado por primera vez (Estimar)
6 de mayo de 2008
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de agosto de 2013
Última actualización enviada que cumplió con los criterios de control de calidad
16 de agosto de 2013
Última verificación
1 de agosto de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- IUSN-0604-01B
- CDR0000584262 (Identificador de registro: PDQ (Physician Data Query))
- 5R01CA115983-05 (Subvención/contrato del NIH de EE. UU.)
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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