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临床试验/NCT02750124
NCT02750124Unknown不适用

IT-system Development for Individualization of Cervix Cancer Screening and Implementation of New Strategies to Reach Non-attenders

Karolinska Institutet0 个研究点目标入组 8,000 人开始时间: 2016年3月14日最近更新:
适应症

试验速览

阶段
不适用
入组人数
8,000
主要终点
Proportion of women responding (either by and HPV test or a Pap test)

研究概览

简要总结

The main purpose is to develop and test an IT-infrastructure to provide more individualized ways of inviting and reaching women who have not participated, despite having been invited with annual reminders, in cervix cancer screening program during a ten year period.

详细描述

BACKGROUND Non-participation in the screening program is the main risk factor for cervical cancer (Andrae et al JNCI, 2008). Therefore it is important to reduce barriers to screening and facilitate participation in the screening program for cervical cancer. Offering self-sampling kits for human papillomavirus (HPV) testing has been examined in several research studies as a way to reach women who have not responded to screening invitations.

Results from a population-based, randomized study in western Sweden concluded that by offering HPV self-sampling kits to screening non-attendees, 17% of cervical cancer cases could be avoided. Offering self-sampling kits to women who have not attended screening in the organized program, can lead to greater participation without substantial increases in the overall health care costs. While there is a growing body of evidence supporting the use of self-sampling, it is unclear how this strategy can be implemented effectively in the context of an organized screening program. An alternative is to offer women the chance to speak with a coordinating midwife who can answer questions and address concerns regarding screening. It is unclear how the results of different research studies should be put into practical use within an organized screening program. Currently, women who have not attended screening are sent an annual reminder invitation. We want to examine whether these alternative strategies (self-sampling and contact with a midwife) may work as well, or better, than current strategy of reminder invitations to non-attenders.

AIM The aim of this randomized health services study is therefore both to test the feasibility of providing alternative strategies instead of the customary reminder invitations to women in Stockholm (so-called feasibility study, primary aim), and whether such strategies will increase overall participation in screening (secondary aim).

STUDY DESIGN AND METHODOLOGY A new IT infrastructure for ordering a self-sampling kit has been developed by LabMed, KI. This in conjunction with the screening database, will be used to identify and invite women who are long-term non-participants in cervical screening. Women who have not participated for ten years, despite annual reminder invitations, will be identified and randomized to one of four strategies.

  1. A validated HPV self-sampling kit will be sent directly to women with a study invitation letter and instructions.
  2. An invitation to order an HPV self-sampling kit through an online application will be sent.
  3. An invitation to call the coordinating midwife with questions and concerns regarding screening will be sent.
  4. The standard annual reminder invitation will be sent (control, routine practice)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
33 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Non-participants in cervical cancer screening during a 10 year period

排除标准

  • Active refusers

结局指标

主要结局

Proportion of women responding (either by and HPV test or a Pap test)

时间窗: From recruitment until end of study on December 31st 2016 (average 8 months)

Participation rate in screening

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joakim Dillner

Professor

Karolinska Institutet

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