【ChiCTR2100052120】The effect of educational intervention on knowledge level of cervical cancer and screening, screening intention and Pap test uptake among Chinese immigrant women: A pilot study.

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基本信息

登记号

ChiCTR2100052120

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2021-10-19

临床申请受理号

靶点

适应症

Cervical cancer

试验通俗题目

The effect of educational intervention on knowledge level of cervical cancer and screening, screening intention and Pap test uptake among Chinese immigrant women: A pilot study.

试验专业题目

The effect of educational intervention on knowledge level of cervical cancer and screening, screening intention and Pap test uptake among Chinese immigrant women: A pilot study.

申办单位信息

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

1. To develop an evidence-based educational intervention with navigation assistance for Chinese immigrant women. 2. To develop a training programme for Chinese LHWs and evaluate its effect on improving knowledge and competency of taking up the role of LHWs. 3. To evaluate the feasibility and acceptability of an evidence-based educational intervention with navigation assistance among Chinese immigrant women. 4. To preliminarily evaluate the effect of an evidence-based educational intervention on knowledge level of cervical cancer and screening, cervical cancer screening intention and Pap test uptake among Chinese immigrant women.

试验分类

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试验类型

随机平行对照

试验分期

探索性研究/预试验

随机化

Randomization allocation will be performed by a computer-generated random schedule (www.randomization.com). The study uses block randomization with a block size of four and a 1:1 allocation. Then, an independent statistician will get the random number. The group assignment number card will be put into opaque sealed

盲法

Blinding lay health workers is not possible because they know when they deliver the intervention due to the group allocation. Research assistant 1 who helps to recruit participants, collect baseline data at T0 (T0, before randomization), and allocate participants randomly will not be blinded. Research assistant 2 who collect data at 1 month after a health talk before 1st telephone follow up (T1) and after 3 months post intervention received by intervention group (T2) will be blinded to participants allocation.

试验项目经费来源

Nil

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-09-05

试验终止时间

2022-12-31

是否属于一致性

入选标准

To be included in the study, the inclusion criteria are Chinese immigrants aged 25 years or older who have a history of sexual activity, have not attend cervical cancer screening in the past 3 years; reside in Hong Kong less than 7 years, have not been previously diagnosed with cervical cancer; have not attend any intervention or educational programme related to cervical cancer screening within 1 year; and are able to communicate in Mandarin or Cantonese and read Traditional or Simplified Chinese.；

排除标准

The exclusion criteria are women whose origin is not Mainland; are mentally unfit and cannot give valid consent.；

研究者信息

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试验机构

Nil

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研究负责人邮编