- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT07802054
Messages That Motivate: Communicating Alcohol-Related Breast Cancer Risk to Young Adult Women (MEMO)
Visão geral do estudo
Status
Descrição detalhada
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: The Ohio State University Comprehensive Cancer Center
- Número de telefone: 800-293-5066
- E-mail: OSUCCCClinicaltrials@osumc.edu
Locais de estudo
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Ohio
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Columbus, Ohio, Estados Unidos, 43210
- The Ohio State University Comprehensive Cancer Center
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Investigador principal:
- Darren Mays, MPH, PhD
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Contato:
- Darren Mays, MPH, PhD
- Número de telefone: 614-366-2953
- E-mail: Darren.Mays@osumc.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Assigned female at birth
- Age 18-25
- Report drinking alcohol at least once in the past 30 days
- Registered in the United States as a member of the Prolific consumer research platform
- Willing and able to complete procedures in English
Exclusion Criteria:
- Assigned male at birth
- Ages <18 or >25
- Do not report drinking alcohol at least once in the past 30 days
- Not registered in the U.S. as a member of the Prolific consumer research platform
- Not willing or not able to complete procedures
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Arm 1: Risk Only + Industry Deception
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Risk message content
Messages with information about alcohol industry deception
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Experimental: Arm 2: Risk Only + YAW Susceptibility
|
Risk message content
Message content with information about why young adult women are susceptible to breast cancer risk from alcohol consumption
|
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Experimental: Arm 3: Risk Only + Mechanisms
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Risk message content
Message content with information about the mechanism by which alcohol contributes to increased breast cancer risk
|
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Experimental: Arm 4: Efficacy Only + Industry Deception
|
Messages with information about alcohol industry deception
Efficacy Message Content
|
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Experimental: Arm 5: Efficacy Only + YAW Susceptibility
|
Message content with information about why young adult women are susceptible to breast cancer risk from alcohol consumption
Efficacy Message Content
|
|
Experimental: Arm 6: Efficacy Only + Mechanisms
|
Message content with information about the mechanism by which alcohol contributes to increased breast cancer risk
Efficacy Message Content
|
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Experimental: Arm 7: Risk and Efficacy + Industry Deception
|
Risk message content
Messages with information about alcohol industry deception
Efficacy Message Content
|
|
Experimental: Arm 8: Risk and Efficacy + YAW Susceptibility
|
Risk message content
Message content with information about why young adult women are susceptible to breast cancer risk from alcohol consumption
Efficacy Message Content
|
|
Experimental: Arm 9: Risk and Efficacy + Mechanisms
|
Risk message content
Message content with information about the mechanism by which alcohol contributes to increased breast cancer risk
Efficacy Message Content
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Message Perceptions
Prazo: This assessment is administered immediately after participants view study messages on Day 1
|
We will assess message perceptions using a valid, reliable measure with six questions about whether participants thought the messages were worth remembering, grabbed their attention, and were informative, powerful, convincing, and meaningful. Responses are on a five-point Likert scale from 1 (Strongly disagree) to 5 (Strongly agree). For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean. Higher values are considered a better outcome. |
This assessment is administered immediately after participants view study messages on Day 1
|
|
Effect Perceptions
Prazo: This assessment is administered immediately after participants view study messages on Day 1
|
We will capture message effects perceptions using the abbreviated effects perceptions scale.
Items include questions about how much the messages made them feel discouraged to drink alcohol, concerned about drinking alcohol, and made them feel that drinking alcohol is unpleasant on a scale from 1 (Strongly disagree) to 5 (Strongly agree).
For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean.
Higher values are considered a better outcome.
|
This assessment is administered immediately after participants view study messages on Day 1
|
|
Emotional Response
Prazo: This assessment is administered immediately after participants view study messages on Day 1
|
We will capture emotional responses to the messages using a valid, four item scale.
Items are "This message made me angry; irritated; aggravated; and annoyed" with responses on a 5-point Likert scale from 1 (Not likely at all) to 5 (Extremely likely).
For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean.
Higher values are considered a better outcome.
|
This assessment is administered immediately after participants view study messages on Day 1
|
|
Counter-arguing
Prazo: This assessment is administered immediately after participants view study messages on Day 1
|
We will capture counter-arguing, a measure of whether participants cognitively refute messages, with a valid, three item scale that captures whether participants criticize messages, think of points that go against messages, and are skeptical of the messages.
Responses are on a 5-point Likert scale ranging from 1 (Not at all) to 7 (Very much).
For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean.
Lower values are considered a better outcome.
|
This assessment is administered immediately after participants view study messages on Day 1
|
|
Behavioral Intentions
Prazo: This assessment is administered immediately after participants view study messages on Day 1
|
Intentions to reduce alcohol consumption in the future will also be assessed with a valid, multi-item scale capturing whether participants will avoid drinking alcohol completely, reduce the number of occasions when they drink alcohol, and reduce the amount of alcohol they consume on drinking occasions with a 1 (Definitely Will Not) to 4 (Definitely Will) response scale.
For all message response outcomes, we will sum and average responses to the items to create message-level scores, then compute means across both messages within each condition for a grand mean.
Higher values are considered a better outcome.
|
This assessment is administered immediately after participants view study messages on Day 1
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Darren Mays, MPH, PhD, The Ohio State University Comprehensive Cancer Center
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
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
Outros números de identificação do estudo
- OSU-26048
- R01CA311193-01 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CIF
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