- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01672944
Evaluating Biobanking Educational Tools
The purpose of this study is to evaluate English and Spanish language educational materials that inform the community about a type of cancer research that involves the collection, storage, and processing of biospecimens. Part A of this study involved creating surveys about biospecimen donation and research. Now, a randomized controlled trial (RCT) will begin to evaluate education materials about biospecimen donation and research.
Phase II consists of two independent randomized controlled trials. Each trial is being conducted independently to test English and Spanish language materials (75 subjects each).
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Florida
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Tampa, Florida, Estados Unidos, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
English Language RCT Inclusion Criteria:
- scheduled for an appointment at Lifetime Cancer Screening (LCS)
- able to read and speak English
- able to provide informed consent
Spanish Language RCT Inclusion Criteria:
- receiving care at a participating clinic from the Suncoast Community Health Centers network
- able to read and speak Spanish
- able to provide informed consent
Exclusion Criteria:
- previously diagnosed with cancer
- previously participated in a biobank
- participated in another TBCCN-related study entitled "community perceptions on biobanking"
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Experimental: TBCCN-developed educational materials
Biobanking educational DVD and booklet kit developed by the Tampa Bay Community Network (TBCCN) Center.
English kit is entitled "Biobanking Hope for a Cancer Cure", and Spanish kit is entitled "Biobanco: Una esperanza de cura para el cancer."
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Participants will be asked to view the educational materials developed by TBCCN, in either English or Spanish depending on the RCT in which they are enrolled.
These materials include a DVD and a booklet that were developed to enhance community members' understanding and awareness of biospecimen collection and biobanking from healthy individuals.
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Outro: Control Group
Biobanking educational Brochure developed by the National Cancer Institute.
English brochure is entitled "Providing your Tissue for Research: What you need to Know", Spanish brochure is entitled "Lo que usted debe saber antes de dar sus tejidos para investigación médica."
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Participants will be asked to view the English biobanking educational Brochure entitled "Providing your Tissue for Research: What you need to Know", or Spanish brochure entitled "Lo que usted debe saber antes de dar sus tejidos para investigación médica."
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
BANKS-Knowledge Scale
Prazo: Average of 28 days
|
Administered at baseline and between 7 and 28 days after enrollment.
Description: A validated 16-item questionnaire measuring knowledge about biobanking.
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Average of 28 days
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BANKS-Attitudes Scale
Prazo: Average of 28 days
|
Administered at baseline and between 7 and 28 days after enrollment.
Description: A validated 15-item questionnaire measuring attitudes toward biobanking.
|
Average of 28 days
|
BANKS-Self-Efficacy Scale
Prazo: Average of 28 days
|
Administered at baseline and between 7 and 28 days after enrollment.
Description: A validated 12-item questionnaire measuring self-efficacy in regards to donating a biospecimen to a biobank.
|
Average of 28 days
|
BANKS-Intentions
Prazo: Average of 28 days
|
Administered at baseline.
Description: A single item measuring intentions to donate a biospecimen to a biobank.
|
Average of 28 days
|
Decisional Self-Efficacy
Prazo: Average of 28 days
|
Administered at follow-up (between 7 and 28 days after enrollment).
Description: A validated 11-item questionnaire measuring participant's confidence in making a decision about donating a biospecimen (O'Connor M.A. Decision Self-efficacy Scale.
1995; www.ohri.ca/decisionaid).
|
Average of 28 days
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
BANKS-Trust Scale
Prazo: Average of 28 days
|
Administered at baseline and between 7 and 28 days after enrollment.
Description: A validated 10-item questionnaire measuring trust related to organizations, facilities, and people that may be involved in research.
|
Average of 28 days
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Clement Gwede, PhD, MPH, RN, H. Lee Moffitt Cancer Center and Research Institute
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
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
Outros números de identificação do estudo
- MCC-16448
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