Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer (PROSHADE)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Prostate Cancer; Prostate-Specific Antigen; Decision Making, Shared
• Intervention / Treatment: Other: Mixed-method approach

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.

• Study Type: Observational
• Enrollment (Anticipated): 1781

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Other: Mixed-method approach; 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.	Other: Mixed-method approach; 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.	Other: Mixed-method approach; Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)

What is the study measuring?

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2022
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 9, 2021
• First Submitted That Met QC Criteria: December 24, 2021
• First Posted (Actual): January 12, 2022

Study Record Updates

• Last Update Posted (Actual): May 17, 2022
• Last Update Submitted That Met QC Criteria: May 16, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PI20/01334

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No