- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT05187949
Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer (PROSHADE)
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
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.
Typ studiów
Zapisy (Oczekiwany)
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Metoda próbkowania
Badana populacja
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.
Opis
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Inny
- Perspektywy czasowe: Przekrojowe
Kohorty i interwencje
Grupa / Kohorta |
Interwencja / Leczenie |
|---|---|
|
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)
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Patients' and clinicians' knowledge on PSA test questionnaire developed by the investigators
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
|
Współpracownicy i badacze
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Oczekiwany)
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PI20/01334
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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