Desarrollo de nuevos materiales educativos sobre pruebas genéticas para un grupo diverso de pacientes con cáncer (IMAGINE)
IMAGINE: Mejorar el acceso a la información genética para todos: un ensayo prospectivo de un modelo de integración lingüística y culturalmente apropiado para pruebas de panel de múltiples genes de cáncer hereditario entre diversos pacientes con cáncer
Genetic testing is a type of test that detects changes to the genes-the DNA instructions that are passed on from the mother and father. The results of a genetic test can confirm whether the participant has a genetic disorder, which is a disease caused in whole or in part by changes to the genes. Genetic testing can also help determine a person's chance of getting or passing on a genetic disorder. Genetic tests use a sample of blood, hair, skin, or other tissue, and they can look at one gene or multiple genes at the same time. Genetic testing may change the options for treating people with certain types of cancer. For example, some medications are more helpful for the treatment of cancer in people with certain gene changes (mutations).
The researchers are doing this study to develop new educational materials about genetic testing for people who speak different languages and have diverse cultural and educational backgrounds. During the study, the staff will interview participants with diverse cultural and educational backgrounds and ask them to review a sample of the educational materials that have been developed so far. Participants will give their opinions on these materials, and the researchers will use participants' feedback to improve the materials.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The objective of this proposal is to develop, test and evaluate a mainstreaming (LCAM) model for hereditary cancer multigene panel testing (MGPT) among many different types of cancer patients. The central hypothesis is that this LCAM genetic testing model will lead to better patient decision-making, psychosocial, and behavioral outcomes than a traditional model of genetic services represented by our standard-of-care arm. In Phase 1, the researchers will first conduct formative research including transcreation and cognitive interviewing to adapt our existing educational materials (brochure and video) and clinical communication materials (clinic visit summary and family dissemination messaging) for the LCAM model to be useful for patients of many different backgrounds. In Phase 2, the researchers will conduct a randomized clinical trial (RCT) to test and evaluate effects of the LCAM model for hereditary cancer MGPT as compared to standard-of-care among the patients treated at local community hospitals. Patients diagnosed with breast, colorectal, ovarian, pancreatic, or prostate cancer will be offered hereditary cancer MGPT through either: i) standard-of-care wherein in-depth pre-test and post-test genetic counseling are provided via telegenetics (videoconferencing), or ii) LCAM intervention wherein patients receive adapted pretest educational materials from study staff and/or clinical staff and have testing ordered by their oncologist, followed by post-test genetic counseling via telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials. Participants will be followed prospectively and will complete assessments consisting of validated and investigator-designed measures. Phase 2 primary outcomes include genetic test decision satisfaction and genetic counseling satisfaction. Secondary outcomes include additional decision-making, psychosocial, and behavioral outcomes.
For Phase 2, participants will be recruited from our partnering sites, which include Kings County Hospital Center, Queens Cancer Center, Jamaica Hospital Medical Center, and the MSK Ralph Lauren Center for Cancer Care as well via referrals from underserved community sites through the MSK RLCCC network. Study staff will identify eligible patients from review of clinic lists and patient medical records, and will also receive direct study referrals from clinicians located at the partnering sites. Study staff will approach eligible patients in order to describe the study, screen them for eligibility (including assessing language proficiency via self-report and prior experience with cancer genetic counseling/testing), and obtain informed consent and collect their contact information.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jennifer Hay, PhD
- Número de teléfono: 646-888-0039
Copia de seguridad de contactos de estudio
- Nombre: Jada Hamilton, PhD, MPH
- Número de teléfono: 646-888-0049
- Correo electrónico: hamiltoj@mskcc.org
Ubicaciones de estudio
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New York
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Brooklyn, New York, Estados Unidos, 11203
- Reclutamiento
- Kings County Hopsital Center
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Contacto:
- Jason Gonsky, MD
- Número de teléfono: (718) 245-2847
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Jamaica, New York, Estados Unidos, 11432
- Reclutamiento
- Queens Cancer Center of Queens Hospital
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Contacto:
- Linda Bulone, RN, OCN, CCRC
- Número de teléfono: (718) 883-2958
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New York, New York, Estados Unidos, 10035
- Reclutamiento
- Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
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Contacto:
- Jada Hamilton, PhD, MPH
- Número de teléfono: 646-888-0049
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Richmond Hill, New York, Estados Unidos, 11418
- Reclutamiento
- Jamaica Hospital Medical Center (Data Collection Only)
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Contacto:
- Rosa Nouvini, MD
- Número de teléfono: (718) 206-6000
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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:
Phase 1
- Age ≥ 18 years as per self-report
- Current or previous diagnosis of breast, ovarian, pancreatic, or prostate cancer as per self-report
- Self-identification as Black, Latino, and/or neither Black nor Latino (i.e.,non-Latino, Non black)
- Fluency in English, Haitian Creole, or Spanish as per self-report (for Spanish, we will attempt to recruit a cohort representing a variety of regions where Spanish is spoken, as informed by current data from participating sites, to achieve neutrality in the language) Fluency is defined as an answer of "well" or "very well" on the screening questions for spoken and reading ability.
Phase 2:
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Age ≥ 18 years as per the medical record and/or clinician referral
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Current or previous diagnosis of breast, colorectal, ovarian, pancreatic, or prostate cancer meeting at least one of the applicable criteria for the cancer type as per the medical record and/or clinician referral:
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Breast cancer criteria:
- any diagnosis age 65 or younger;
- diagnosis of triple negative breast cancer at any age;
- multiple primary breast cancers at any age;
- under consideration for PARP therapy;
- any family history (1st, 2nd, or 3rd degree relatives) of ovarian or pancreas cancer, or 1 relative with breast cancer who meets the above criteria, or 2 relatives with breast cancer at any age; or clinician discretion)
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colorectal cancer
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Ovarian cancer criteria:
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invasive ovarian cancer
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Pancreatic cancer criteria:
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pancreatic adenocarcinoma
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Prostate cancer criteria:
- castrate-resistant, metastatic prostate cancer;
- high-risk prostate cancer (pending pathology definition)
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Fluency in English, Haitian Creole, or Spanish as per self-report. Fluency is defined as an answer of "well" or "very well" on the screening questions for spoken ability
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No prior cancer genetic counseling or germline testing for cancer risk as per self-report clinician's note, and/or no clinical documentation
Exclusion Criteria:
Phase 1:
- Individuals of impaired decision-making capacity as per a clinician's or consenting professional's judgment.
- Subjects who indicate level of fluency as "not at all" or "not well".
Phase 2:
- Individuals of impaired decision-making capacity as per a clinician's or consenting professional's judgment.
- Subjects who indicate level of fluency as "not at all" or "not well".
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: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Cognitive interview intervention for Phase 1
There is no treatment or intervention for Phase 1 of this study. Participants will be asked to participate in a cognitive interview. This section will be amended to include the Phase 2 intervention information once the Phase 1 portion of the study is complete. The Phase 1 materials developed, and results obtained, will directly be part of and inform the intervention for Phase 2.Phase 2: participants will be randomized to the standard-of-care arm or the LCAM intervention arm. |
Researchers will use formative methods to adapt our previously-developed mainstreaming pre-genetic test educational materials plus standard post-test clinical communication materials used by the MSK CGS for use with the diverse patients. Specifically, it will adapt these materials to be responsive to patients' linguistic and literacy needs, and sensitive to their cultural diversity. |
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Comparador activo: Standard of care (Phase II only randomization)
Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics |
Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics |
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Comparador activo: LCAM Intervention (Phase II only randomization)
Participants will receive adapted pretest educational materials from study staff and/or clinical staff and have testing ordered by their oncologist, followed by post-test genetic counseling via telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials. |
Participants will receive adapted pretest educational materials from study staff and/or clinical staff and have testing ordered by their oncologist, followed by post-test genetic counseling via telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number of patients who complete the cognitive interview (Phase I)
Periodo de tiempo: 1 year
|
the number of patients who complete the cognitive interview |
1 year
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Genetic test decision (Phase II) satisfaction
Periodo de tiempo: 6 months
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is measured with the validated Satisfaction with Decisions scale. |
6 months
|
|
Genetic counseling satisfaction (Phase II)
Periodo de tiempo: 6 months
|
is measured with the validated Genetic Counseling Satisfaction scale |
6 months
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Test uptake (Phase II)
Periodo de tiempo: 6 months
|
the number of patients who complete multigene panel testing |
6 months
|
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Knowledge (Phase II)
Periodo de tiempo: 6 months
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measured with items from the validated KnowGene scale (scores range from 0 to 6, higher scores indicate greater knowledge) |
6 months
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Empowerment (Phase II)
Periodo de tiempo: 6 months
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measured with the validated Genomics Outcome Scale (scores range from 6 to 30, higher scores indicate greater empowerment) |
6 months
|
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Distress (Phase II)
Periodo de tiempo: 6 months
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measured with the validated Hospital Anxiety and Depression Scale (total scale scores range from 0 to 42, higher scores indicate greater distress) |
6 months
|
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Concerns about genetic testing (Phase II)
Periodo de tiempo: 6 months
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measured with the validated Multidimensional Impact of Cancer Risk Assessment questionnaire (total scale scores range from 0 to 95, higher scores indicate greater concerns about genetic testing) |
6 months
|
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Family communication (Phase II)
Periodo de tiempo: 6 months
|
measured with investigator-designed items |
6 months
|
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Family cascade testing (Phase II)
Periodo de tiempo: 6 months
|
the number of first-degree relatives who complete genetic testing |
6 months
|
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Intentions to adopt risk management behaviors (Phase II)
Periodo de tiempo: 6 months
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measured with items derived from the Behavioral Risk Factor Surveillance System and National Health Interview Survey |
6 months
|
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Long term engagement and understanding (Phase II)
Periodo de tiempo: 6 months
|
measured with investigator-designed items |
6 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Jada Hamilton, PhD, MPH, Memorial Sloan Kettering Cancer Center
Publicaciones y enlaces útiles
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
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Neoplasias Genitales Masculinas
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades Genitales Masculinas
- Enfermedades prostáticas
- Enfermedades urogenitales masculinas
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades intestinales
- Neoplasias Gastrointestinales
- Neoplasias del Sistema Digestivo
- Enfermedades del Sistema Digestivo
- Enfermedades Gastrointestinales
- Neoplasias Intestinales
- Enfermedades Rectales
- Enfermedades Genitales Femeninas
- Neoplasias de glándulas endocrinas
- Enfermedades pancreáticas
- Enfermedades del Colon
- Enfermedades Ováricas
- Enfermedades anexiales
- Neoplasias Genitales Femeninas
- Trastornos gonadales
- Enfermedades de la piel
- Enfermedades de los senos
- Enfermedades de la piel y del tejido conectivo
- Neoplasias prostáticas
- Neoplasias colorrectales
- Neoplasias Ováricas
- Neoplasias de mama
- Neoplasias pancreáticas
- Administración de Servicios de Salud
- Calidad, acceso y evaluación de la atención médica
- Calidad de la atención médica
- Indicadores de calidad, atención médica
- Estándar de cuidado
Otros números de identificación del estudio
- 20-458
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Información sobre medicamentos y dispositivos, documentos del estudio
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