Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer

Prostate Cancer Clinical Trial

— PROSHADE  

Official title:

Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05187949
• Other study ID #: PI20/01334
• Status: Not yet recruiting
• Start date: July 2022
• Est. completion date: December 2023

Study information

• Verified date: May 2022
• Source: Universidad Miguel Hernandez de Elche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1781
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Decision Making, Shared
• Prostate Cancer
• Prostate-Specific Antigen
• Prostatic Neoplasms

Intervention

Other:
• Mixed-method approach
Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Universidad Miguel Hernandez de Elche	Consorcio Centro de Investigación Biomédica en Red, M.P., Hospital de Sant Pau, Hospital General Universitario de Alicante, Hospital Universitario San Juan de Alicante, Universidad Católica San Antonio de Murcia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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