Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer

Study Overview
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Brief Summary
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In this project, the investigators aim to evaluate the most appropriate design and implementation strategy of a decision-aid to promote shared-decision making in prostate cancer screening.

Detailed Description
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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.

Official Title
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Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer

Conditions
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Decision Making, Shared, Prostate-Specific Antigen, Prostate Cancer

Intervention / Treatment
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* Other: Mixed-method approach


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>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 | Other: Mixed-method approach<br>* Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)<br>|
| General Practitioners<br>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. | Other: Mixed-method approach<br>* Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)<br>|
| Urologists<br>Quantitative study: 345 Urologists working in Valencian Community, Spain Qualitative study: urologists focus groups: 1. | Other: Mixed-method approach<br>* Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' and clinicians' knowledge on PSA test questionnaire developed by the investigators | 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 | 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 | 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 |