Protocolo para o Desenvolvimento e Teste da Eficácia de um Programa Educativo de Autodetecção do Cancro de Pele: Um Ensaio Controlado Aleatório
Protocolo para o Desenvolvimento e Teste da Eficácia de um Programa Educativo de Autodetecção do Cancro da Pele: Um Ensaio Controlado Aleatorizado
Skin cancer is a significant public health concern, even in an Asian society like Singapore where it ranks among the top 10 cancers. This RCT tests the effectiveness of a skin cancer educational intervention to improve skin cancer outcomes among skin-of-color individuals, including the effects of gain versus loss framing.
Visão geral do estudo
Status
Descrição detalhada
Reducing skin cancer related morbidity and mortality involves two broad domains; (1) Identification and early detection of skin cancers and (2) Awareness and behavioral change to reduce modifiable risk factors like UV exposure. Regular self-examination and public education have been shown in RCTs to improve knowledge and identification of skin cancers. However most of these existing studies and the tools they utilise rely on Western-centric photographs and messaging, such as the 'ABCDE rule' for superficial spreading and nodular melanoma. These neglect skin cancers far more common in skin of colour population such as acral lentiginous melanomas, pigmented basal cell and squamous cell carcinomas.
In addition to improving detection, effective behavioural change strategies are needed to encourage protective practices such as regular sunscreen use. Message framing has gained interest as a behavioral change technique: gain-framed messages emphasize the benefits of adopting a behavior, while loss-framed messages highlight the negative consequences of not doing so. Although message framing is widely used in health communication, evidence of its effectiveness in promoting skin cancer-related behaviors is unclear.
Effectiveness of our proposed intervention can help to increase adoption of sun protective behaviours, improve detection rates of skin cancer and allow earlier medical intervention, hence reducing morbidity and mortality of skin cancer.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Ellie Choi, MBBS
- Número de telefone: 65 6908 2222
- E-mail: dermresearchec@nuhs.edu.sg
Locais de estudo
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Singapore, Cingapura, 609783
- Recrutamento
- National University Hospital
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Contato:
- Ellie Choi
- Número de telefone: 67795555
- E-mail: dermresearchec@nuhs.edu.sg
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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:
- Individuals aged 16 and above
- Able to read and converse in English
- Able to provide informed consent
- Having the ability to use and interact with a web server or application.
Exclusion Criteria:
- Individuals who have cognitive impairment or decline to participate. There will be no exclusion criteria based on a previous history of skin cancer.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Comparador de Placebo: Control
Participants will fill up a baseline competency examination and questionnaire, and another at the 4 month mark. Access to the intervention for control group participants will only be provided after the 4-month questionnaire is completed. |
Participants in the control group will gain access to the intervention websites after the 4-month questionnaire is completed. |
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Experimental: Intervention with gain framing
Participants will fill up a baseline competency examination and questionnaire. Afterwards, they will have access to a website with gain-framed messages emphasising benefits of adopting a behaviour. Thereafter, another competency questionnaire will be administered following completion of material. |
This educational website will feature gain-framing messages, emphasizing the benefits of adopting a behavior, utilising positive language and analogies. The interventional domains are (1) Education on skin cancer risk factors and epidemiology, (2) UV Protection Advice, (3) Skin Self-Examination Techniques and (4) Differentiating benign vs malignant skin conditions. |
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Experimental: Intervention with loss framing
Participants will fill up a baseline competency examination and questionnaire. Afterwards, they will have access to a website with loss-framed messages highlighting consequences of failing to adopt a behaviour. Thereafter, another competency questionnaire will be administered following completion of material. |
This educational website will feature loss-framing messages, highlight the consequences of failing to adopt a behavior, utilising negative language and analogies. The interventional domains are (1) Education on skin cancer risk factors and epidemiology, (2) UV Protection Advice, (3) Skin Self-Examination Techniques and (4) Differentiating benign vs malignant skin conditions. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Change in competency scores
Prazo: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Scores measured as percentage of correct questions answered. Range from 0% to 100% with higher score indicating higher ability to differentiate benign from malignant skin lesions. Change in scores will be calculated and compared between
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Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Knowledge of skin cancer, sun protection and skin self-examination
Prazo: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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20 Multiple Choice Questions created based on intervention website. Score range from 0 to 20, with a higher score indicate higher knowledge in risks of skin cancer, appropriate sunscreen use and features of cancerous lesions. |
Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Attitudes toward carrying out sun protection behaviours
Prazo: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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6 questions graded on a 7-point Likert scale, with higher scores indicating better attitudes toward sun protection behaviours |
Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Subjective norms, which refer to participants' perception of whether significant individuals in their lives would support sun protection behaviours
Prazo: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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7 questions graded on a 7-point Likert scale, with higher scores indicating a greater influence of others' perception on their sun protection behaviours |
Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Behavioural outcomes (sun protection behaviour and skin self-examination)
Prazo: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Sun Exposure and Protection Index. 9 questions graded on a 5-point Likert scale assessing sun habits and sun protection behaviour. Lower scores indicate more optimal sun protection behaviours, with an additional adapted question. 11 additional questions regarding participants' sunscreen usage (e.g. type of sunscreen, frequency of reapplication), and skin-self examination, with a lower score indicating more optimal sun protection behaviours. |
Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Intentions of participants toward carrying out skin cancer risk prevention strategies
Prazo: Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Sun Exposure and Protection Index (6 questions with an additional adapted question). Each given response score (0-4) are summed, with scores ranging from 0-24, with higher score indicating a low propensity to increase sun protection. 2 additional questions regarding participants' intentions of conducting a skin-self examination. 7 point Likert Scale (1-7), with higher score indicating higher intentions of conducting a skin-self examination. |
Baseline, immediately post-intervention (for intervention arms), 4 months post-intervention
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Ellie Choi, MBBS, National University Hospital, Singapore
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
Outros números de identificação do estudo
- 2024/00074
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
IPD shared includes de-identified demographics and measures.
Prazo de Compartilhamento de IPD
IPD and supporting information will be available from the time of publication and for four years thereafter.
Critérios de acesso de compartilhamento IPD
Deidentified individual participant data supporting the findings of this study will be available from the corresponding author upon reasonable request. Access will be granted on a case-by-case basis following review and approval of a data access proposal and completion of a data sharing agreement.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- CIF
- ANALYTIC_CODE
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