Desenvolvimento de novos materiais educativos sobre testes genéticos para um grupo diversificado de pacientes com câncer (IMAGINE)
IMAGINE: Melhorando o acesso à informação genética para todos - um teste prospectivo de um modelo de integração lingüística e culturalmente apropriado para testes de painéis multigênicos de câncer hereditário entre diversos pacientes com câncer
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jennifer Hay, PhD
- Número de telefone: 646-888-0039
Estude backup de contato
- Nome: Jada Hamilton, PhD, MPH
- Número de telefone: 646-888-0049
- E-mail: hamiltoj@mskcc.org
Locais de estudo
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New York
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Brooklyn, New York, Estados Unidos, 11203
- Recrutamento
- Kings County Hopsital Center
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Contato:
- Jason Gonsky, MD
- Número de telefone: (718) 245-2847
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Jamaica, New York, Estados Unidos, 11432
- Recrutamento
- Queens Cancer Center of Queens Hospital
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Contato:
- Linda Bulone, RN, OCN, CCRC
- Número de telefone: (718) 883-2958
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New York, New York, Estados Unidos, 10035
- Recrutamento
- Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
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Contato:
- Jada Hamilton, PhD, MPH
- Número de telefone: 646-888-0049
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Richmond Hill, New York, Estados Unidos, 11418
- Recrutamento
- Jamaica Hospital Medical Center (Data Collection Only)
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Contato:
- Rosa Nouvini, MD
- Número de telefone: (718) 206-6000
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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".
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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. |
|
Comparador Ativo: 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 |
|
Comparador Ativo: 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. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of patients who complete the cognitive interview (Phase I)
Prazo: 1 year
|
the number of patients who complete the cognitive interview |
1 year
|
|
Genetic test decision (Phase II) satisfaction
Prazo: 6 months
|
is measured with the validated Satisfaction with Decisions scale. |
6 months
|
|
Genetic counseling satisfaction (Phase II)
Prazo: 6 months
|
is measured with the validated Genetic Counseling Satisfaction scale |
6 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Test uptake (Phase II)
Prazo: 6 months
|
the number of patients who complete multigene panel testing |
6 months
|
|
Knowledge (Phase II)
Prazo: 6 months
|
measured with items from the validated KnowGene scale (scores range from 0 to 6, higher scores indicate greater knowledge) |
6 months
|
|
Empowerment (Phase II)
Prazo: 6 months
|
measured with the validated Genomics Outcome Scale (scores range from 6 to 30, higher scores indicate greater empowerment) |
6 months
|
|
Distress (Phase II)
Prazo: 6 months
|
measured with the validated Hospital Anxiety and Depression Scale (total scale scores range from 0 to 42, higher scores indicate greater distress) |
6 months
|
|
Concerns about genetic testing (Phase II)
Prazo: 6 months
|
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
|
|
Family communication (Phase II)
Prazo: 6 months
|
measured with investigator-designed items |
6 months
|
|
Family cascade testing (Phase II)
Prazo: 6 months
|
the number of first-degree relatives who complete genetic testing |
6 months
|
|
Intentions to adopt risk management behaviors (Phase II)
Prazo: 6 months
|
measured with items derived from the Behavioral Risk Factor Surveillance System and National Health Interview Survey |
6 months
|
|
Long term engagement and understanding (Phase II)
Prazo: 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
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Doenças do Sistema Endócrino
- Neoplasias Genitais Masculinas
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Genitais, Masculino
- Doenças prostáticas
- Doenças Urogenitais Masculinas
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Doenças Intestinais
- Neoplasias gastrointestinais
- Neoplasias do Aparelho Digestivo
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Neoplasias Intestinais
- Doenças retais
- Doenças Genitais Femininas
- Neoplasias das Glândulas Endócrinas
- Doenças pancreáticas
- Doenças do cólon
- Doenças ovarianas
- Doenças anexiais
- Neoplasias Genitais Femininas
- Distúrbios Gonadais
- Doenças de pele
- Doenças da mama
- Doenças da Pele e do Tecido Conjuntivo
- Neoplasias prostáticas
- Neoplasias Colorretais
- Neoplasias ovarianas
- Neoplasias da Mama
- Neoplasias Pancreáticas
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Qualidade de assistência médica
- Indicadores de qualidade, assistência médica
- Padrão de atendimento
Outros números de identificação do estudo
- 20-458
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
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