- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05187949
Promoting Shared-decision Making in Opportunistic Screening for Prostate Cancer (PROSHADE)
연구 개요
상세 설명
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.
연구 유형
등록 (예상)
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
Inclusion Criteria:
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.
Exclusion Criteria:
- Patients: None
- General practitioners: None
- Urologists: None
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 다른
- 시간 관점: 단면
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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 |
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. |
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.
|
Quantitative survey (cross-sectional design) and qualitative analysis (focus groups)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Patients' and clinicians' knowledge on PSA test questionnaire developed by the investigators
기간: December 2022
|
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
기간: March 2023
|
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
기간: December 2023
|
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
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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