Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer (PROSHADE)
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Prostate cancer (PC) screening using Prostate Specific Antigen (PSA) has led to a reduction in advanced disease and disease-specific mortality. However, screening with PSA can also cause harm and is associated with false-positive results and overdiagnosis.
Shared-decision making (SDM) has been defined as the key to successful patient-centered care. The promotion SDM when deciding on PSA screening will have proximal effects such as the development of collaborative deliberation between clinicians and patients, resulting in well-informed patients and in preference-based decisions. As long term effects, it will result in safer, cost-effective, patient-aligned healthcare, and its distant effects will include improvements in resource use, planning processes and improved health outcomes.
The project includes a mixed-method approach. The investigators will perform a quantitative survey (cross-sectional design) to evaluate the population, patients' and clinicians' knowledge about the benefits and risks derived from the PSA determination and the available recommendations.
The investigators will apply qualitative analysis through focus groups, to explore the challenges patients and clinicians face to deep in a prostate screening discussion and to assess the adequacy of different implementation strategies.
The investigators will carry out a user-testing design based on mix-methods (questionnaire and semi-structured review) to evaluate the prototype of the initial decision-aid.
Finally, the investigators will carry out a cluster randomised controlled trial, to assess the results derived from the application of the decision-aid, together with a process evaluation using a combination of both qualitative and quantitative methods to monitor the fidelity of the intervention, the clusters' and patients' response to the intervention as well as the mechanisms of adaptation and change at the intervention.
Tipo de estudo
Inscrição (Antecipado)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Group 1 (patients): Men living in the Valencian Community, Spain. Group 2 (general practitioners): Primary care doctors working in the Valencian Community, Spain.
Group 3 (urologists): Urologists working in the Valencian Community, Spain.
Descrição
Inclusion Criteria:
Patients:
- Men >40 years old
- Men who have not had prostate cancer
General practitioners:
- Primary care doctors working in the Valencian Community, Spain.
Urologists:
- Urologists working in the Valencian Community, Spain.
Exclusion Criteria:
- Patients: None
- General practitioners: None
- Urologists: None
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Outro
- Perspectivas de Tempo: Transversal
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
|
Patients
Quantitative study: Surveys: 1,067 out of a total of 1,389,725 people of residents of the Valencian Community, Spain. Three groups with quota control: proportional to age (40-50; 50-70; > 70 years) of men aged 40 and over who have not had prostate cancer from each stratum (geographical area and population habitat). Qualitative study: general population focus groups: 3 |
Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)
|
|
General Practitioners
Quantitative study: 369 General Practitioners working in two Health Departments in the Valencian Community, Spain (Dept of Health Alicante, General Hospital 19, 255,439 habitants) and (Dept of Health Alicante, S Juan Alicante 17, 233,115 habitants). Qualitative study: general practitioners focus groups: 2. |
Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)
|
|
Urologists
Quantitative study: 345 Urologists working in Valencian Community, Spain Qualitative study: urologists focus groups: 1.
|
Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Patients' and clinicians' knowledge on PSA test questionnaire developed by the investigators
Prazo: December 2022
|
Quantitative questionnaire to evaluate the target population and clinicians' knowledge about the PSA benefits/risks and the available recommendations.
The investigators will develop an ad hoc questionnaire which will be validated through the Delphi Method.
|
December 2022
|
|
Patients' and clinicians' opinions on PSA test
Prazo: March 2023
|
Focus groups to explore qualitatively the challenge patients and clinicians face when discussing prostate cancer screening and to assess their preferences about different designs and implementation strategies.
|
March 2023
|
|
Number of patients who participated in a shared-decision making with their clinicians when receiving a PSA test
Prazo: December 2023
|
The investigators will assess the number of patients who participate in a shared- decision making with their clinicians when receiving a PSA test.
To assess it, the investigators, through a randomized clinical trial, will apply a new decision-aid developed to a group of patients which will be compared with another group which will have normal care.
|
December 2023
|
Colaboradores e Investigadores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Antecipado)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
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
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- PI20/01334
Informações sobre medicamentos e dispositivos, documentos de estudo
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