- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00929097
Implementation of Guidelines on Hereditary or Familial Colorectal Cancer (RISCO)
Implementation of Guidelines on Hereditary or Familial Colorectal Cancer Risk Calculation and Risk Communication
연구 개요
상세 설명
Regular colonoscopy is effective in reducing morbidity and mortality due to colorectal cancer (CRC) in patients at increased familial CRC risk. Currently, the majority of these at-risk individuals are not properly referred for increased surveillance by colonoscopy or genetic counselling. In 2008, a national multidisciplinary evidence-based guideline on familial and hereditary CRC was launched in the Netherlands. Clinicians have new tasks in familial CRC risk calculation, interpretation and communication. A clustered randomized controlled trial including an effect, process and cost evaluation will be conducted in eighteen Dutch hospitals to determine the most cost effective way to implement these new guidelines.
Surgeons and gastroenterologists in both the intervention group and the control group will receive background information on familial colorectal cancer risk and the guidelines. Patients and clinicians in the intervention group will receive an additional intervention strategy.
The effect evaluation is done by assessing the number of CRC patients for whom correct risk calculation, interpretation and communication is performed, as well as patients' uptake of the recommended follow up policy. The actual exposure to the different elements of the implementation procedure and the experiences of users will be assessed in the process evaluation. The costs of the implementation procedure will be determined by means of a cost evaluation.
연구 유형
등록 (예상)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Clinical diagnosis of colorectal cancer before the age of 70
- Diagnosed in one of the participating hospitals
- Able to read and understand Dutch
Exclusion Criteria:
- Previous referral for genetic counseling
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 건강 서비스 연구
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
활성 비교기: 제어
|
Dissemination of guidelines
|
실험적: Implementation aids
|
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
The number of colorectal cancer patients following the most optimal follow up program according to the guidelines.
기간: 1 year
|
1 year
|
2차 결과 측정
결과 측정 |
기간 |
---|---|
The number of patients for whom MSI testing was performed based on the MIPA criteria
기간: 1 year
|
1 year
|
The number of CRC patients for whom a correct familial CRC risk is calculated by clinicians (as compared to formally calculated risks)
기간: 1 year
|
1 year
|
The number of CRC patients for whom a calculated familial CRC risk is correctly interpreted by clinicians
기간: 1 year
|
1 year
|
The number of CRC patients with whom a calculated familial CRC risk and/or follow up policy is communicated by clinicians
기간: 1 year
|
1 year
|
Patients' uptake of the follow up policy
기간: 1 year
|
1 year
|
Actual exposure to the different elements of the implementation strategy
기간: 1 year
|
1 year
|
Experiences of clinicians and patients with the different elements of the implementation strategy
기간: 1 year
|
1 year
|
Costs of the implementation procedure
기간: 1 year
|
1 year
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Nicoline Hoogerbrugge, MD, PhD, Radboud University Medical Center
- 수석 연구원: Rosella PMG Hermens, PhD, Radboud University Medical Center
간행물 및 유용한 링크
일반 간행물
- Dekker N, Hermens RP, Nagengast FM, van Zelst-Stams WA, Hoogerbrugge N; RISCO study group. Familial colorectal cancer risk assessment needs improvement for more effective cancer prevention in relatives. Colorectal Dis. 2013 Apr;15(4):e175-85; discussion p.e185. doi: 10.1111/codi.12117.
- Dekker N, Hermens RP, Elwyn G, van der Weijden T, Nagengast FM, van Duijvendijk P, Salemink S, Adang E, van Krieken JH, Ligtenberg MJ, Hoogerbrugge N. Improving calculation, interpretation and communication of familial colorectal cancer risk: protocol for a randomized controlled trial. Implement Sci. 2010 Jan 28;5:6. doi: 10.1186/1748-5908-5-6.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- ZonMw 80-82315-98-09005
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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