Clinical trial NCT05187949: Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer
Official title: Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Decision Making, Shared
Prostate-Specific Antigen
Prostate Cancer
Lead sponsor: Universidad Miguel Hernandez de Elche
Sponsor class: OTHER
Collaborators: name: Consorcio Centro de Investigación Biomédica en Red (CIBER)
name: Hospital de Sant Pau
name: Hospital Universitario San Juan de Alicante
name: Universidad Católica San Antonio de Murcia
name: Hospital General Universitario de Alicante
First posted: 2022-01-12
Enrollment: 1781
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. Patients:

   * Men \>40 years old
   * Men who have not had prostate cancer
2. General practitioners:

   * Primary care doctors working in the Valencian Community, Spain.
3. Urologists:

   * Urologists working in the Valencian Community, Spain.

Exclusion Criteria:

1. Patients: None
2. General practitioners: None
3. Urologists: None

Primary outcomes:
measure: Patients' and clinicians' knowledge on PSA test questionnaire developed by the investigators
timeFrame: December 2022
measure: Patients' and clinicians' opinions on PSA test
timeFrame: March 2023
measure: Number of patients who participated in a shared-decision making with their clinicians when receiving a PSA test
timeFrame: December 2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: