Oncología personalizada que promueve la equidad para las vidas de las personas de raza negra
The goal of this observational study is to increase genetic education and genetic testing for hereditary cancer risk among Black cancer survivors. The study will:
- Test the effectiveness of a chatbot intervention (also called relational agent, or RA) vs. enhanced usual care (EUC) on engagement in genetic education and requests for genetic testing.
- Evaluate the impact of the chatbot 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.
- Explore the feasibility of incorporating a Family Sharing Portal (FSP) for participants who receive a positive test result, to facilitate family communication of these test results and genetic testing of first-degree biological relatives after they have received genetic education by the RA.
The main questions this study aims to answer are which group - the chatbot (RA) 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 chatbot (RA) group or EUC group. This means each participant has an equal chance of being placed in either group, just like flipping a coin. Each group will receive genetic education and have an opportunity to request genetic testing. Researchers will compare the chatbot (RA) group and the EUC group to see which may request more GT (genetic testing) and which group engages more with genetic education.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Research Design and Methods:
This study will employ a 2-arm parallel group randomized controlled trial to evaluate the efficacy of the RA intervention compared to EUC among 350 Black 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 RA intervention on psychosocial and decision quality outcomes (Aim 2) and evaluate mediators and moderators of intervention impact (Aim 3). In response to patient identified needs, we will also explore the feasibility of incorporating a Family Sharing Portal (FSP). All participants who receive a positive test result will be input into the FSP (Aim 4).
Research Procedures:
The design for this study is a 2-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) or RA. Randomization will be balanced in a 1:1 ratio - with 175 participants randomized to each arm. Because this study is designed to address the disparity of low genetic testing utilization in Black cancer patients, all study participants will be Black and approximately 10% will be Hispanic.
The investigators will utilize the EHRs at our participating sites to identify cancer survivors who have not been tested despite meeting GT eligibility criteria. Participants will be ascertained from 1) Georgetown Lombardi Comprehensive Cancer Center (LCCC), MedStar Washington Cancer Institute (MWCI) and MedStar Franklin Square Medical Center 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 women and men who self-identify as Black or African American, have a history of breast, ovarian, uterine, colorectal, prostate, or pancreatic 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: Erin Speiser, PhD, MA
- Número de teléfono: 732-675-1668
- Correo electrónico: erin.speiser@rutgers.edu
Copia de seguridad de contactos de estudio
- Nombre: Julie Chapman Greene, PhD, MPH
- Correo electrónico: chapmaje@cinj.rutgers.edu
Ubicaciones de estudio
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District of Columbia
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Washington D.C., District of Columbia, Estados Unidos, 20007
- Reclutamiento
- Georgetown Lombardi Comprehensive Cancer Center
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Contacto:
- Lia Sorgen
- Correo electrónico: lia.sorgen@georgetown.edu
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Investigador principal:
- Marc Schwartz, PhD
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Contacto:
- Isabella Alvarez
- Correo electrónico: ia507@georgetown.edu
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New Jersey
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New Brunswick, New Jersey, Estados Unidos, 08901
- Reclutamiento
- Rutgers Cancer Institute
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Contacto:
- Julie Chapman Greene, PhD, MPH
- Correo electrónico: chapmaje@cinj.rutgers.edu
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Contacto:
- Erin Speiser, PhD, MA
- Correo electrónico: erin.speiser@rutgers.edu
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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:
- 18-80 years of age
- Self-identify as Black or African American
- At least 6-months post diagnosis with any of the following cancers: breast, ovarian, uterine, prostate, colorectal, pancreatic
- 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 |
|---|---|
|
Experimental: Relational Agent (RA)
Participants in the RA arm will receive a clinical letter from the institution's clinical genetics program with a link to the RA. The fully HIPAA-compliant RA 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. For participants who wish to proceed directly to GT, the RA will alert staff to these requests and a GT kit will be mailed to them. 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. |
Consists of clinical letter and engagement with genetic education and uptake of genetic testing for hereditary cancer risk among Black cancer survivors. |
|
Comparador activo: Enhanced Usual Care (EUC)
Participants in the EUC arm will also be mailed a clinical letter signed by the Medical Director of the institution's clinical genetics program. 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. |
Consists of clinical letter and recommendation for genetic testing for hereditary cancer risk among Black cancer survivors. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Uptake of Germline Genetic Testing
Periodo de tiempo: 6-months
|
As captured via internal RedCap form for the number or count of participants who opt for genetic testing, the investigators will test the efficacy of a culturally tailored and interactive electronic relational agent (RA) intervention vs. enhanced usual care (EUC) consisting of clinical letter and genetic recommendation on engagement in genetic testing uptake; |
6-months
|
|
Survey Assessment of Impact of RA vs. EUC
Periodo de tiempo: 1-month and 6-month survey
|
Evaluate the impact of the RA 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. |
1-month and 6-month survey
|
|
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. |
Baseline, 1-month and 6-month surveys
|
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
|
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. |
1-month survey
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Anita Y Kinney, PhD, RN, Director at Rutgers Cancer Institute
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
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
Otros números de identificación del estudio
- Pro2022001513
- R01CA277599 (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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