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临床试验/NCT05362669
NCT05362669Unknown不适用

SMS Messaging for Invitation in the HPV-based Cervical Cancer Screening Programme in Catalonia (CERCA-SMS Study)

Institut Català d'Oncologia2 个研究点 分布在 1 个国家目标入组 450 人开始时间: 2021年11月8日最近更新:
适应症

试验速览

阶段
不适用
入组人数
450
试验地点
2
主要终点
Participation in cervical cancer screening program

研究概览

简要总结

A study on two different methods of invitation to participate to the cervical cancer screening programme will be conducted within a demonstration project to switch from cytology-based screening to HPV-based screening using self-sampling delivered through the network of pharmacy offices among regular screening attendants in the Barcelona Metropolitana Sud Area, in Catalonia.

At the moment, eligible women are invited to participate to cervical cancer screening via a telephone call invitation explaining the new self-sampling method. Invitation via SMS containing a link to a webpage with information on most frequent questions might be an adequate alternative method that would save costs and workload on human resources.

The aim of this study is to assess the impact on cervical cancer screening participation of an invitation method based on text messaging (SMS).

The invitation method will be evaluated through an interventional trial, in which we will compare the invitation to cervical cancer screening using SMS versus a telephone call invitation explaining the new self-sampling method.

详细描述

Main Hypothesis:

The use of direct SMS without an explanatory call for cervical cancer screening invitation is an acceptable option to invite women if the participation obtained is more than 70% and not less than 15% of the call (current practice).

Specific Hypothesis:

  • Participation in cervical cancer screening programme using SMS invitation is non-inferior to 70%.
  • Participation in cervical cancer screening programme using telephone call is non-inferior to 70%.
  • Participation using SMS invitation is non-inferior to participation using telephone call invitation, considering that an absolute difference less than 15% may not be clinically relevant.

Sample size calculation:

研究设计

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

入排标准

年龄范围
35 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Eligible women for cervical cancer screening aged 30 to 65 years of age.
  • Registered at the Health Care Database (RCA).

排除标准

  • Individuals without a mobile phone number registered at the RCA.

结局指标

主要结局

Participation in cervical cancer screening program

时间窗: 12 weeks

Participation (no/yes) in cervical cancer screening program will be gathered prospectively 12 weeks after sending the screening invitation (day 0).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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