Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer

NCT05187949 | Unknown

• 1 other identifier: PI20/01334
• Study Type: observational
• Target: 1,781
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

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

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

Urologists

Quantitative study: 345 Urologists working in Valencian Community, Spain Qualitative study: urologists focus groups: 1.

Other: Mixed-method approach

Interventions

Mixed-method approach OTHER

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

General Practitioners; Patients; Urologists

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Patients: None
• General practitioners: None
• Urologists: None

Sponsors & Collaborators

• Universidad Miguel Hernandez de Elche: lead
• Consorcio Centro de Investigación Biomédica en Red (CIBER): collaborator
• Hospital de Sant Pau: collaborator
• Hospital Universitario San Juan de Alicante: collaborator
• Universidad Católica San Antonio de Murcia: collaborator
• Hospital General Universitario de Alicante: collaborator

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 9, 2021
• First Posted: January 12, 2022
• Study Start: July 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: May 17, 2022

Record last verified: 2022-05