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Follow-up of Abnormal and Inadequate Smear-test Results

2016年9月14日 更新者:University of Aarhus

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:

  1. 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
  2. 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.

研究概览

研究类型

介入性

注册 (预期的)

125000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Central Denmark Region
      • Aarhus、Central Denmark Region、丹麦、8000
        • University of Aarhus

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

23年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • woman with a pap-smear test

Exclusion Criteria:

  • less than 23 years

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:卫生服务研究
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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.
有源比较器: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Proportion of women with timely follow-up
大体时间:1½ year
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).
1½ year

次要结果测量

结果测量
措施说明
大体时间
Frequency of general practitioner contacts (consultations/telephone calls /e-mails) regarding conveying the smear test result.
大体时间:Three months after the smear test.
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.
Three months after the smear test.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任:Peter Vedsted、Center for Research in Cancer Diagnosis in Primary Care - (CaP), Aarhus University
  • 研究主任:Flemming Bro、The Research Unit of General Practice in Aarhus, Aarhus University
  • 研究主任:Berit S Andersen、The Department of Public Health Programmes at Regional Hospital Randers

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2012年10月1日

初级完成 (实际的)

2014年10月1日

研究完成 (预期的)

2017年2月1日

研究注册日期

首次提交

2013年11月29日

首先提交符合 QC 标准的

2013年11月29日

首次发布 (估计)

2013年12月5日

研究记录更新

最后更新发布 (估计)

2016年9月15日

上次提交的符合 QC 标准的更新

2016年9月14日

最后验证

2015年12月1日

更多信息

与本研究相关的术语

其他研究编号

  • Cervix cancer screening

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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