- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT03200366
Comparing Interventions to Increase Colorectal Cancer Screening
Comparing Interventions to Increase Colorectal Cancer Screening in Low-Income and Minority Patients
The purpose of this study is to test different approaches to help people understand the purpose of colorectal cancer (CRC) screening, two screening test options available, and the barriers to screening so they can make informed decisions about CRC screening. Participants will be randomly assigned to one of three groups: (1) one group will receive a tailored digital video disc (DVD) in the mail; (2) another group will receive the mailed DVD plus telephone calls from a patient navigator; and (3) the third group will receive the care normally provided by the healthcare system's endoscopy department.
The investigators hypothesize the following: (1) participants who receive the tailored DVD plus the patient navigation intervention will have higher rates of CRC screening with the fecal immunochemical test (FIT), colonoscopy, or either screening test compared to those who receive the tailored DVD alone; (2) participants who receive either intervention (DVD only or DVD plus patient navigation) will have higher rates of CRC screening with FIT, colonoscopy, or either screening test than those who receive usual care; and (3) participants who receive either intervention who complete colonoscopy will have better quality of bowel preparation, less anxiety about the procedure, and greater satisfaction with the colonoscopy experience than those who receive usual care.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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-
Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Eskenazi Health
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Nursing
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Referred for a screening colonoscopy that was not done (i.e, canceled or no show)
Exclusion Criteria:
- Unable to speak, read, and write English
- Personal history of CRC or polyps
- Personal history of conditions that place participants at high risk for CRC such as ulcerative colitis, Crohn's disease, or known hereditary syndromes such as familial adenomatous polyposis or hereditary nonpolyposis colorectal cancer
- Family history of CRC which increases the participant's risk for CRC
- Advised by a health care provider to not have a colonoscopy due to the participant's health
- Speech impairment
- Hearing impairment
- Cognitive impairment
- Vision impairment
Plan de estudios
¿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: Tailored DVD
Tailored digital video disc (DVD)
|
A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants.
It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.
|
Comparador activo: Tailored DVD + Patient Navigation
Tailored digital video disc (DVD) plus Patient Navigation by a population health nurse in the healthcare system
|
A 20 minute tailored DVD titled "Approaches to Colon Testing" is viewed by participants.
It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed.
Participants talk by telephone with a Patient Navigator who is a trained nurse.
The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content.
The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support.
|
Sin intervención: Usual Care
Care normally provided by a nurse in the endoscopy department of the healthcare system
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Participants Completing CRC Screening Per Electronic Medical Record Documentation
Periodo de tiempo: 12 months post-baseline interview
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Number of participants completing CRC screening by any test (defined as colonoscopy or FIT) is measured by electronic medical record review.
Dates that participants had a colonoscopy and dates of FIT analysis are extracted from the electronic medical record.
|
12 months post-baseline interview
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Participants Completing Colonoscopy Per Electronic Medical Record Documentation
Periodo de tiempo: 12 months post-baseline interview
|
Number of participants completing a colonoscopy is measured by electronic medical record review (EMR).
Dates that participants completed a colonoscopy are extracted from the EMR.
|
12 months post-baseline interview
|
Bowel Preparation Quality Rating Using Boston Bowel Preparation Scale
Periodo de tiempo: 12 months post-baseline interview
|
Participants quality of bowel preparation is measured by the endoscopist during their colonoscopy procedure using the Boston Bowel Preparation Scale (BBPS).
BBPS scores the total quality on a 10 point scale from 0-9.
Higher scores indicate better quality of bowel preparation.
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12 months post-baseline interview
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Participants With Adequate Quality of Bowel Preparation Per Modified Aronchick Rating Scale
Periodo de tiempo: 12 months post-baseline interview
|
Participants quality of bowel preparation is measured by the endoscopist during their colonoscopy using a modification of the Aronchick rating scale.
The Aronchick scale rates quality as 1=excellent, 2=good, 3=fair, or 4=poor.
Some endoscopists choose to grade quality more generally as adequate vs. inadequate.
To accommodate this variation, bowel preparation ratings have been dichotomized into adequate (excellent, good, fair, or adequate ratings) vs. inadequate (poor or inadequate ratings).
Adequate is scored as 1 and indicates better quality of bowel preparation than inadequate which is scored as 0.
|
12 months post-baseline interview
|
Colonoscopy-Related Procedural Anxiety for Participants Completing a Colonoscopy
Periodo de tiempo: 12 months post-baseline interview
|
Colonoscopy-related procedural anxiety is measured by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory.
Each item is scored from 1 to 4 (1=not at all; 4=very much so) with higher scores indicating greater anxiety.
|
12 months post-baseline interview
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Satisfaction With Colonoscopy Experience
Periodo de tiempo: 12 months post-baseline interview
|
Satisfaction with the colonoscopy experience is measured by self-report using a single item developed by the research team.
Satisfaction is rated from 1 to 4 where 1=not at all satisfied, 2=a little satisfied, 3=mostly satisfied, and 4=completely satisfied.
Scores range from 1 to 4 with higher scores indicating greater satisfaction.
|
12 months post-baseline interview
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Participants Completing a Fecal Immunochemical Test (FIT) Per Electronic Medical Record Documentation
Periodo de tiempo: 12 months post-baseline interview
|
Number of participants completing a FIT is measured by electronic medical record review (EMR).
Dates of FIT analysis are extracted from the EMR.
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12 months post-baseline interview
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Participants Who Self-Reported Completing CRC Screening
Periodo de tiempo: 6-9 months post-baseline interview
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Number of participants who reported completing CRC screening by any test (defined as colonoscopy or FIT) during the 6 or 9 month post-baseline telephone interview.
|
6-9 months post-baseline interview
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Participants Who Self-Reported Completing a Colonoscopy
Periodo de tiempo: 6-9 months post-baseline interview
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Number of participants who reported completing a colonoscopy during the 6 or 9 month post-baseline telephone interview.
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6-9 months post-baseline interview
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Participants Who Self-Reported Completing a Fecal Immunochemical Test (FIT)
Periodo de tiempo: 6-9 months post-baseline interview
|
Number of participants who reported completing a FIT during the 6 or 9 month post-baseline telephone interview.
|
6-9 months post-baseline interview
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Change in Knowledge of CRC and Screening
Periodo de tiempo: 6 months post-baseline interview
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Change from baseline in knowledge of CRC and screening is measured at 6 months by self-report using a 9-item multidimensional scale.
Each item is scored as 1=correct or 0=incorrect and summed to yield a scale score.
Scores range from 0 to 9 with higher summated scores indicating greater knowledge of CRC and screening tests.
The mean of the 9 items is calculated at baseline and 6 months post-baseline.
Change from baseline equals the mean at 6 months minus the mean at baseline.
Change can range from -9 to 9 with positive values indicating an increase in knowledge.
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6 months post-baseline interview
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Change in Perceived Risk for CRC
Periodo de tiempo: 6 months post-baseline interview
|
Change from baseline in perceived risk for CRC is measured by self-report at 6 months using a 3-item scale.
We ask participants how likely it is that they will get colon cancer sometime during their lifetime, within the next 10 years, and within the next 5 years.
Each item is scored from 1 to 4 (1=very unlikely; 4=very likely).
Higher scores indicate a higher perceived risk for getting CRC.
The mean of the 3 items is calculated at baseline and 6 months.
Change in perceived risk equals the mean at 6 months minus the mean at baseline.
Change can range from -3 to 3 with positive values indicating an increase in perceived risk for getting CRC.
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6 months post-baseline interview
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Change in Colonoscopy-Related Procedural Anxiety Regardless of Whether or Not Participants Had a Colonoscopy
Periodo de tiempo: 6 months post-baseline interview
|
Change from baseline in colonoscopy-related procedural anxiety is measured at 6 months by self-report using the 6-item short form of the State Anxiety Scale of the State-Trait Anxiety Inventory.
Each item is scored from 1 to 4 (1=not at all; 4=very much so) with higher scores indicating greater anxiety.
The mean of the 6 items is calculated at baseline and 6 months post-baseline.
Change from baseline is the mean at 6 months minus the mean at baseline.
Change can range from -3 to 3 with positive values indicating an increase in anxiety.
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6 months post-baseline interview
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Change in Perceived Benefits of CRC Screening by Colonoscopy
Periodo de tiempo: 6 months post-baseline interview
|
Change from baseline in perceived benefits of CRC screening by colonoscopy is measured at 6 months by self-report using a 4-item scale.
Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 4 items calculated.
Higher mean scores indicate greater perceived benefits of screening by colonoscopy.
Change in perceived benefits equals the mean at 6 months minus the mean at baseline.
Change can range from -3 to 3 with positive values indicating an increase in perceived benefits of screening by colonoscopy.
|
6 months post-baseline interview
|
Change in Perceived Barriers to CRC Screening by Colonoscopy
Periodo de tiempo: 6 months post-baseline interview
|
Change from baseline in perceived barriers to CRC screening by colonoscopy is measured at 6 months by self-report using a 16-item scale.
Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 16 items calculated.
Higher mean scores indicate greater perceived barriers to screening by colonoscopy.
Change in perceived barriers equals the mean at 6 months minus the mean at baseline.
Change can range from -3 to 3 with negative values indicating a decrease in perceived barriers to screening by colonoscopy.
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6 months post-baseline interview
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Change in Perceived Self-Efficacy for CRC Screening by Colonoscopy
Periodo de tiempo: 6 months post-baseline interview
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Change from baseline in perceived self-efficacy for colonoscopy is measured at 6 months by self-report using an 11-item scale.
Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 11 items calculated.
Higher mean scores indicate greater perceived self-efficacy for screening by colonoscopy.
Change in perceived self-efficacy equals the mean at 6 months minus the mean at baseline.
Change can range from -3 to 3 with positive values indicating an increase in perceived self-efficacy for screening by colonoscopy.
|
6 months post-baseline interview
|
Change in Perceived Benefits of CRC Screening by FIT
Periodo de tiempo: 6 months post-baseline interview
|
Change from baseline in perceived benefits of CRC screening by FIT is measured at 6 months by self-report using a 3-item scale.
Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 3 items calculated.
Higher mean scores indicate greater perceived benefits of screening by FIT.
Change in perceived benefits equals the mean at 6 months minus the mean at baseline.
Change can range from -3 to 3 with positive values indicating an increase in perceived benefits for screening by FIT.
|
6 months post-baseline interview
|
Change in Perceived Barriers to CRC Screening by FIT
Periodo de tiempo: 6 months post-baseline interview
|
Change from baseline in perceived barriers to CRC screening by FIT is measured at 6 months by self-report using a 10-item scale.
Each item is scored from 1 to 4 (1=strongly disagree; 4=strongly agree) and the mean of the 10 items calculated.
Higher mean scores indicate greater perceived barriers to screening by FIT.
Change in perceived barriers equals the mean at 6 months minus the mean at baseline.
Change can range from -3 to 3 with negative values indicating a decrease in perceived barriers to screening by FIT.
|
6 months post-baseline interview
|
Change in Perceived Self-Efficacy for CRC Screening by FIT
Periodo de tiempo: 6 months post-baseline interview
|
Change from baseline in perceived self-efficacy for CRC screening by FIT is measured at 6 months by self-report using a 7-item scale.
Each item is scored from 1 to 4 (1=not at all sure; 4=very sure) and the mean of the 7 items calculated.
Higher mean scores indicate greater perceived self-efficacy for screening by FIT.
Change in perceived self-efficacy equals the mean at 6 months minus the mean at baseline.
Change can range from -3 to 3 with positive values indicating an increase in perceived self-efficacy for screening by FIT.
|
6 months post-baseline interview
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Susan M Rawl, PhD,RN, Indiana University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1605880142
- IHS-1507-31333 (Otro número de subvención/financiamiento: Patient-Centered Outcomes Research Institute (PCORI))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Marco de tiempo para compartir IPD
Criterios de acceso compartido de IPD
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA 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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