Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer

NCT ID: NCT05187949

Last Updated: 2022-05-17

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 1781 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-31
• Study Completion Date: 2023-12-31

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.

Conditions

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

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

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

Mixed-method approach

Intervention Type: OTHER

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.

Mixed-method approach

Intervention Type: OTHER

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.

Mixed-method approach

Intervention Type: OTHER

Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)

Interventions

Mixed-method approach

Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)

Intervention Type: OTHER

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Consorcio Centro de Investigación Biomédica en Red (CIBER)

OTHER_GOV

Sponsor Role: collaborator

Hospital de Sant Pau

OTHER

Sponsor Role: collaborator

Hospital Universitario San Juan de Alicante

OTHER

Sponsor Role: collaborator

Universidad Católica San Antonio de Murcia

OTHER

Sponsor Role: collaborator

Hospital General Universitario de Alicante

OTHER

Sponsor Role: collaborator

Universidad Miguel Hernandez de Elche

OTHER

Sponsor Role: lead

Responsible Party

Blanca Juana Lumbreras Lacarra

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PI20/01334

Identifier Type: -

Identifier Source: org_study_id