Expanding Genetic Access for Prostate Cancer Survivors (ENGAGE)
Expanding Genetic Access and Guided Education for Prostate Cancer Survivors
The goal of this study is to increase genetic education and genetic testing for hereditary cancer risk among prostate cancer survivors. The study will:
Test the effectiveness of a digital guide (DG+) vs. print guide (Print+) vs. enhanced usual care (EUC) on engagement in genetic education and uptake of genetic testing.
Evaluate the impact of the DG+ vs. Print+ vs. EUC on the process that participants use to make decisions and evaluate effects on well-being (also called psychosocial outcomes).
Explore the ways (methods) that influence how participants experience the intervention.
The main questions this study aims to answer are: which group - the digital guide (DG+) group, print (Print+) group or the EUC group - is more likely to request genetic testing and which group is more likely to get (engage with) genetic education.
Participants will be randomly assigned to either the digital guide (DG+) group, the print guide (Print+) group or EUC group. Each group will receive genetic education and have an opportunity to request genetic testing. Researchers will compare the three groups to determine which is most most likely to complete genetic testing (GT) and which group engages more with genetic education.
Descripción general del estudio
Estado
Descripción detallada
Research Design and Methods:
This study will employ a 3-arm parallel group randomized controlled trial to evaluate the efficacy of the DG+ and Print+ interventions compared to EUC among 500 prostate cancer survivors who meet the National Comprehensive Cancer Network's guidelines for genetic referral. Primary outcomes will be engagement with genetic education and uptake of genetic testing (Aim 1). The investigators will also evaluate the impact of the interventions on psychosocial and decision quality outcomes (Aim 2) and evaluate mediators and moderators of intervention impact (Aim 3).
Research Procedures:
The design for this study is a 3-arm parallel group trial. Randomization is at the patient level. The investigators will recruit eligible cancer survivors who will be randomized by computer to enhanced usual care (EUC), DG+ or Print+ in a 1:2:2 ratio - with 100 participants randomized to EUC (control) arm and 200 randomized the each of the intervention arms (DG+ and Print+).
The investigators will utilize the EHRs at our participating sites to identify prostate cancer survivors who have not been tested despite meeting GT eligibility criteria. Participants will be ascertained from 1) Georgetown Lombardi Comprehensive Cancer Center (LCCC) and MedStar Washington Cancer Institute (MWCI) in DC and 2) Rutgers' Cancer Institute (in New Brunswick and at University Hospital Newark) including RWJ Barnabas Health community oncology sites. Participants will be men who have a history of prostate cancer, are at least six-months post-diagnosis, and have received care at one of the participating sites in the prior five years. There is no limit on the years since diagnosis as genetic testing (GT) can guide treatment decisions and provide opportunities for cascade testing to guide screening and prevention in at-risk relatives.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Marc Schwartz
- Número de teléfono: 202-687-0185
- Correo electrónico: schwartm@georgetown.edu
Ubicaciones de estudio
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20007
- Georgetown University Medical Center/Lombardi Comprehensive Cancer Center
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08903
- Rutgers University/Rutgers Cancer Institute
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Contacto:
- Anita Kinney, PhD
- Número de teléfono: 732-675-1937
- Correo electrónico: anita.kinney@rutgers.edu
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Investigador principal:
- Anita Kinney, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- 18-80 years of age
- At least 6-months post diagnosis with prostate cancer
- Have not had genetic testing for hereditary cancer
- Have received care at one of the participating sites in the prior five years
- Meet National Comprehensive Cancer Network criteria for germline GT
- Able to read and speak in English
- Capable of providing informed consent
- Have internet access (via smartphone, tablet or computer)
- Comfortable using a computer or mobile phone independently to access information
Exclusion Criteria:
- Do not speak English
- Unable to access the Internet
- Have previously undergone germline genetic testing for hereditary cancer risk or previously had genetic counseling (GC) and declined genetic testing (GT)
- Are unable to provide informed consent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Enhanced Usual Care (EUC)
Participants in the EUC arm will be mailed a clinical letter.
The letter sent to EUC participants will inform them of their own and their family's potential risk for carrying a pathogenic variant (PV) related to hereditary cancer.
The letter will emphasize their eligibility for GT, include a recommendation to consider scheduling a GC appointment to obtain more information, and include a link to the Rutgers Cancer Institute or LCCC high-risk clinic website.
The study team will help facilitate GT when requested by the participant.
Results will be shared with the participant, their oncologist and tailored per the result.
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Consists of clinical letter and recommendation/referral to schedule a genetic counseling session.
Otros nombres:
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Experimental: Print Genetic Education plus Streamlined Genetic Testing (Print+)
Participants in the Print+ arm will receive a clinical letter from the institution's clinical genetics program along with a copy of the print education guide and a genetic testing kit.
The print guide provides detailed information regarding risk for hereditary cancer and options for genetic testing comparable to the information conveyed in traditional genetic counseling (GC).
Information is conveyed through a combination of text, infographics, and images.
Print+ participants who wish to proceed directly to GT can request an out-of-pocket cost estimate and then return the GT kit directly to the testing lab.
Results will be shared with the participant, their oncologist and tailored per the result.
Participants who indicate that they are unsure or do not want GT will be encouraged to discuss their risk and GT options with their oncology provider and to schedule a GC appointment with the clinic.
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Consists of clinical letter, genetic testing kit, and a print genetic education guide along with streamlined access to genetic testing for hereditary cancer risk.
Otros nombres:
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Experimental: Digital Guide Genetic Education Plus Streamlined Genetic Testing (DG+)
Participants in the DG+ arm will receive a clinical letter from the institution's clinical genetics program with a link to the RA along with a genetic testing kit.
The fully HIPAA-compliant DG will provide comparable educational information to traditional genetic counseling (GC) but in a streamlined and tailored manner including video, education and decision support, patient testimonial and answers to questions in real-time.
Participants will be informed that they may speak to a genetic risk specialist free of charge.
Participants who wish to proceed directly to GT can indicate this within the DG.
They will be provided with a GT out-of-pocket cost estimate before returning the GT kit.
Results will be shared with the participant, their oncologist and tailored per the result.
Participants who indicate that they are unsure or do not want GT will be encouraged by RA to discuss their risk and GT options with their oncology provider and to schedule a GC appointment with the clinic.
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Consists of clinical letter, genetic testing kit, and access to a genetic education digital guide along with streamlined access to genetic testing for hereditary cancer risk.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Uptake of Germline Genetic Testing
Periodo de tiempo: 6-Months
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As captured via internal RedCap form for the number or count of participants who opt for genetic testing during the six-month study period.
The investigators will compare the three study arms to evaluate efficacy of the DG+ and Print+ interventions compared to EUC and to each other.
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6-Months
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Survey Assessment of Impact of DG+ vs. Print+ vs. EUC
Periodo de tiempo: 1-Month and 6-Month surveys
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Evaluate the impact of the DG+ vs. Print+ vs. EUC on informed decision-making and psychosocial outcomes via survey measures of related constructs at 1-month and 6-month surveys.
Multiple scales are used to measure this outcome and each scale has a unique scoring system.
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1-Month and 6-Month surveys
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Survey Assessment of Mediators and Moderators of Efficacy
Periodo de tiempo: Baseline, 1-Month and 6-Month surveys
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Explore potential mechanisms by assessing mediators and moderators of efficacy via survey measures of related constructs at baseline, 1-month and 6-month surveys.
Multiple scales are used to measure this outcome and each scale has a unique scoring system.
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Baseline, 1-Month and 6-Month surveys
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Survey Assessment of Engagement with Genetic Education
Periodo de tiempo: 1-Month Survey
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Engagement with genetic education/counseling via survey measures of related constructs at 1-month survey.
Multiple scales are used to measure this outcome and each scale has a unique scoring system.
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1-Month Survey
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
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
- Enfermedades urogenitales
- Enfermedades Genitales
- Neoplasias Genitales Masculinas
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades Genitales Masculinas
- Enfermedades prostáticas
- Enfermedades urogenitales masculinas
- Neoplasias prostáticas
- Organización y administración
- Administración de Servicios de Salud
- Técnicas de investigación
- Métodos epidemiológicos
- Estadísticas como tema
- Biometría
- Biometric Identification
- Security Measures
- Dermatoglyphics
Otros números de identificación del estudio
- 25-08-272
- R01CA296911 (Subvención/contrato del NIH de EE. UU.)
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.
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