- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02002468
Follow-up of Abnormal and Inadequate Smear-test Results
Follow-up of Abnormal and Inadequate Test Results in the Danish Cervical Cancer Screening Program.
Denmark has a higher incidence of cervical cancer than other Nordic countries, although all Danish women (aged 23-65) are screened regularly to identify possible cervical dysplasia or asymptomatic invasive cancer.
Annually 40 000 women receives an abnormal or inadequate test result and a follow-up recommendation.
However problems with delayed follow-up may threaten the effectiveness of the Danish Cervical Cancer Screening Program, as 20% of women are delayed and dysplasia potentially can progress into cancer.
Delayed follow-up is found in situations where women either consciously or unconsciously postpone follow-up, or because of organizational aspects of the screening program, where communication regarding test results can fail either in content or with delay.This study will evaluate two interventions designed to increase follow-up:
- A letter with the test result and potential recommendation for follow up will be sent to the women (RCT). The intention is to ensure that all women will be notified about the test result, quickly, homogenously and in layman's written language, still with the opportunity to contact or be contacted by the general practitioner, if there is special needs. Furthermore, it is assumed that general practitioner consultations regarding delivery of normal test results will decrease, so that cost savings is a potential side benefit
- Electronic reminder to the general practitioner if women have not had the recommended follow up, giving the general practioner´s an opportunity to remind the women (retro perspective cohort study).
The results will be of great importance to the future organisation of cervical and colorectal cancer screening programmes in Denmark, but will also have international interest because of their similar challenges.
연구 개요
상태
정황
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Central Denmark Region
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Aarhus, Central Denmark Region, 덴마크, 8000
- University of Aarhus
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- woman with a pap-smear test
Exclusion Criteria:
- less than 23 years
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 |
|---|---|
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실험적: Test result sent by letter
The pap-smear test result is sent by letter directly to the women.
Women in need of follow up are in the letter recommended to contact their general practitioner.
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활성 비교기: Test result conveyed by general practitioners
In Denmark it is a standard procedure that general practitioners convey the pap-smear test results to the women.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of women with timely follow-up
기간: 1½ year
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The proportion of women followed up will be calculated as cumulated incidence proportions according to four timeframes (undesirable early, as recommended, late, very late), and be compared by relative risks.
The results will be presented in totals and separately depending on the test result (normal/inadequate/Bethesda classification 2001/HPV).
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1½ year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of general practitioner contacts (consultations/telephone calls /e-mails) regarding conveying the smear test result.
기간: Three months after the smear test.
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The two randomisation groups will be compared with respect to contacts with general practitioner after the smear test the first days, weeks, months after the general practitioner is notified of the screening result.
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Three months after the smear test.
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공동 작업자 및 조사자
수사관
- 연구 책임자: Peter Vedsted, Center for Research in Cancer Diagnosis in Primary Care - (CaP), Aarhus University
- 연구 책임자: Flemming Bro, The Research Unit of General Practice in Aarhus, Aarhus University
- 연구 책임자: Berit S Andersen, The Department of Public Health Programmes at Regional Hospital Randers
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
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
추가 관련 MeSH 약관
기타 연구 ID 번호
- Cervix cancer screening
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