Improving Health Literacy in African-American Prostate Cancer Patients
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Investigators propose an observational interview study to explore how patients understand treatment conversations with their physicians within the framework of health literacy. The study team will test whether patients' understanding of treatment options and side effects can be improved when patients receive a low literacy educational supplement after meeting with their urologist. Investigators will interview a group of newly diagnosed, early stage, African American prostate cancer patients.
Investigators hypothesize that the delivery of a scripted, tailored, low literacy educational supplement will result in a statistically significant decrease in decisional conflict, and a statistically significant improvement in comprehension of cancer treatment and its side effects compared to standard practice.
The study team will measure patients' comprehension of treatment options and side effects, as well as decisional conflict; after standard practice, and again after exposure to the educational supplement. Investigators will compare the urologists' assessment of patients' 1) health literacy 2) preferences for side effects 3) stage of decision making, 4) treatment choice or predisposition toward treatment choice. 5) preference for role in decision making (active, passive, or shared with physician); to measures obtained from patients. These comparisons will allow investigators to quantify the potential benefit to the physician of information obtained through the interview and low literacy educational supplement.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Georgia
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Atlanta, Georgia, Estados Unidos, 30303
- Grady Memorial Hospital
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Atlanta, Georgia, Estados Unidos, 30342
- Emory Saint Joseph's Hospital
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Atlanta, Georgia, Estados Unidos, 30322
- Emory University
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Atlanta, Georgia, Estados Unidos, 30033
- Atlanta VA Medical Center
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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:
- Patients who have undergone pathology review of their prostate biopsy at Emory University, Grady Memorial Hospital, Saint Joseph's Hospital, and Atlanta VA Medical Center with AJCC clinical stage T1-T2 prostate cancer by physical exam
Exclusion Criteria:
- RN or MD degree
- History of head injury or dementia
- History of cognitive impairment
- Unable to undergo the informed consent process and the study interview in English per the judgment of the primary urologist or urological provider
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Educational Supplement
Participants diagnosed with prostate cancer will receive education for treatment options and treatment side effects.
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Participants will receive education about prostate cancer and treatments using models and props during a face-to-face interview.
During the interview, participants will also be asked about medical terms and treatments regarding prostate cancer.
The interview will last 45 to 60 minutes.
Participants will receive traditional standard of care education regarding prostate cancer treatments and side effects provided by their physician.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in Decisional Conflict Scale Score
Periodo de tiempo: Baseline, Post-Intervention (Up to 6 Weeks)
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The decisional conflict scale measures personal perceptions of : a) uncertainty in choosing options; b) modifiable factors contributing to uncertainty such as feeling uninformed, unclear about personal values and unsupported in decision making; and c) effective decision making such as feeling the choice is informed, values-based, likely to be implemented and expressing satisfaction with the choice.
Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict).
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Baseline, Post-Intervention (Up to 6 Weeks)
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Change in Comprehension of Treatment Options Score assessed by Interview
Periodo de tiempo: Baseline, Post-Intervention (Up to 6 Weeks)
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Comprehension of treatment options will be scored as dichotomous variables, correct or incorrect.
The changes in the proportion of patients who correctly understand treatment after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.
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Baseline, Post-Intervention (Up to 6 Weeks)
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Change in Comprehension of Side Effects Score assessed by Interview
Periodo de tiempo: Baseline, Post-Intervention (Up to 6 Weeks)
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Comprehension of side effects will be scored as dichotomous variables, correct or incorrect.
The changes in the proportion of patients who correctly understand side effects after standard practice compared to the proportion who correctly understand treatment after the low literacy supplement will be analyzed.
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Baseline, Post-Intervention (Up to 6 Weeks)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Rapid Estimate of Adult Literacy in Medicine (REALM) Score
Periodo de tiempo: Baseline
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The REALM is a screening instrument to assess an adult patient's ability to read common medical words and lay terms for body parts and illnesses. Scores are assessed on an education grade equivalent; 0-18 = 3rd Grade and Below Will not be able to read most low literacy materials; will need repeated oral instructions, materials composed primarily of illustrations, or audio or video tapes 19-44 = 4th to 6th Grade Will need low literacy materials; may not be able to read prescription labels 45-60 = 7th to 8th Grade Will struggle with most patient education materials 61-66 = High School Will be able to read most patient education materials |
Baseline
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Change in the Stage of Decision Making Scale Score
Periodo de tiempo: Baseline, Post-Intervention (Up to 6 Weeks)
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Stage of decision making refers to individual's readiness to engage in decision making, progress in making a choice, and receptivity to considering or re-considering options.
This tool is not scored.
However, the categories can be used to determine co-variation in decisional conflict (tends to be higher in earlier stages) and success of interventions (success higher among those in active deliberation stage).
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Baseline, Post-Intervention (Up to 6 Weeks)
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Kerry Kilbridge, MD, Dana-Farber Cancer Institute
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
- IRB00091879
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
producto fabricado y exportado desde los EE. UU.
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Ensayos clínicos sobre Cancer de prostata
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Fundacao ChampalimaudTerminado
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University of Colorado, DenverColorado State UniversityRetiradoRealidad virtual | Diagnóstico por imagen | Educación del paciente | Paciente con cancerEstados Unidos
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Dana-Farber Cancer InstituteTerminadoCancer de RIÑON | Cancer de prostata | Cáncer genitourinarioEstados Unidos
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Rabin Medical CenterReclutamiento
Ensayos clínicos sobre Educational Supplement
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