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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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注册号：

Registration number：

 ChiCTR2100052120 

最近更新日期：

Date of Last Refreshed on：

 2021-10-19 03:49:45 

注册时间：

Date of Registration：

 2021-10-19 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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.

Public title：

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.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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.

Scientific title：

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.

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

FUNG WING YEE 

研究负责人：

FUNG WING YEE 

Applicant：

FUNG WING YEE 

Study leader：

FUNG WING YEE 

申请注册联系人电话：

Applicant telephone：

 +852 54233461

研究负责人电话：

Study leader's
telephone：

+852 54233461

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 fung_wingyee@yahoo.com.hk

研究负责人电子邮件：

Study leader's E-mail：

 fung_wingyee@yahoo.com.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

FLAT D, 9/F, BLOCK 1, WALDORF GARDEN, TUEN MUN, Hong Kong, China

研究负责人通讯地址：

FLAT D, 9/F, BLOCK 1, WALDORF GARDEN, TUEN MUN, Hong Kong, China

Applicant address：

FLAT D, 9/F, BLOCK 1, WALDORF GARDEN, TUEN MUN, Hong Kong, China

Study leader's address：

FLAT D, 9/F, BLOCK 1, WALDORF GARDEN, TUEN MUN, Hong Kong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2021.413

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-09-29 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓1樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35053935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

Nil

Primary sponsor：

NIL

研究实施负责（组长）单位地址：

Nil

Primary sponsor's address：

NIL

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Nil

Source(s) of funding：

nil

研究疾病：

Cervical cancer  

Target disease：

Cervical cancer

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

The study consists of 3 phases. In Phase I, the intervention in the study is designed for Chinese immigrant women, based on literature review findings, with the intervention consisting of two main components: (1) health talk led by a lay health worker (LHW) and(2) monthly telephone follow-up with navigation assistance. A health talk will be delivered by a LHW. Each participant can join a health talk once according to their availability. A PowerPoint is prepared for a health talk delivery. During the explanation of the Pap test procedure, the participants will be asked to watch a 4-minute video clip to know about the procedure in detail. A booklet will be distributed to each participant. The booklet contains a copy of all the information presented in the health talk. The lay health workers will carry out monthly telephone follow up to encourage them to have a Pap test. Navigation assistance will be offered by lay health workers to overcome the barriers of accessing to service and increase the Pap test uptake. The duration of telephone follow-up 2 months is adopted in current study. In Phase II, the investigator will recruit 6 LHWs from 3 community centers or association located at Sham Shui Po, Kwun Tong and Yuen Long. Chinese immigrant women who are members of community centers or graduate from high school and fulfill the criteria will be recruited to train as LHW. The eligible LHW will attend 2-days online training and 2-hours onsite visit or online workshop before delivering intervention to Chinese immigrant women. The time and the date of training and workshop will be finalized under mutual agreement. The effectiveness of the training programme will be evaluated by knowledge of cervical cancer and screening and competence of LHWs. For the knowledge of cervical cancer and screening, a 20 multiple choice questions in the written test will be used as pre-test and post-test. The passing mark is 16, 80% of total score. For competence evaluation, there are two parts for assessment including health talk and telephone follow-up. An author-developed checklist will be used. LHWs need to returndemonstrate how to deliver a health talk and telephone follow-up. LHWs require achieving at least 80% items in the checklist.Moreover, LHWs will be asked to complete an author-developed satisfactory survey after completion of training programme. In Phase III, a pilot wait-list randomized controlled study will be adopted. The feasibility and acceptability of the intervention and the preliminary effect of intervention on knowledge level, screening intention and Pap test uptake rate among Chinese immigrant women will be evaluated. The design of current pilot study is taking 40 participants in total sample size. Thus, 20 participants per group is a result. The eligible participants will be randomly assigned to either the intervention group or control group. The participants in the intervention group receive intervention first while participants in the wait-list control group receive delayed intervention after completion of data collection. The study will be conducted in three different community centers or associations where is the same centers of LHWs. Participants in this study will be recruited by convenience samplings. After screening the eligibility of applicants, research assistant 1 (RA1) will make appointment with participants to provide information sheet, sign written consent form and complete baseline data collection in person. RA1 communicates with LHWs and participants (intervention group) in the same center to arrange a health talk. LHWs will conduct 1 hour health talk and monthly telephone follow-up with navigation support for 2 months. Research assistant 2 (RA 2) will collect relevant data at T1 (1 month after delivering a health talk) and at T2 (3 months after post intervention received by intervention group) for all participants by using phone contact. All data or information will be collected by using a structured questionnaire in Simplified Chinese version or Traditional Chinese version. The parameters on feasibility such as screened potential participants, eligibility rate, consent rate, withdrawal rate and attrition rate among Chinese immigrant women will be calculated. The acceptability of intervention among participants will be evaluated by using author-developed satisfactory survey. To measure Pap test uptake rate among Chinese immigrant women, participants will be asked whether they have taken a Pap test within six months. Knowledge level of participants regarding cervical cancer and screening will be evaluated by using Cervical Cancer Screening Knowledge Scale. Screening intention will be evaluated by using a 5-point Likert Scale, from extremely unlikely to extremely likely. Data will be entered into IBM SPSS version 26.0 for analysis. 

Description for medicine or protocol of treatment in detail：

The study consists of 3 phases. In Phase I, the intervention in the study is designed for Chinese immigrant women, based on literature review findings, with the intervention consisting of two main components: (1) health talk led by a lay health worker (LHW) and(2) monthly telephone follow-up with navigation assistance. A health talk will be delivered by a LHW. Each participant can join a health talk once according to their availability. A PowerPoint is prepared for a health talk delivery. During the explanation of the Pap test procedure, the participants will be asked to watch a 4-minute video clip to know about the procedure in detail. A booklet will be distributed to each participant. The booklet contains a copy of all the information presented in the health talk. The lay health workers will carry out monthly telephone follow up to encourage them to have a Pap test. Navigation assistance will be offered by lay health workers to overcome the barriers of accessing to service and increase the Pap test uptake. The duration of telephone follow-up 2 months is adopted in current study. In Phase II, the investigator will recruit 6 LHWs from 3 community centers or association located at Sham Shui Po, Kwun Tong and Yuen Long. Chinese immigrant women who are members of community centers or graduate from high school and fulfill the criteria will be recruited to train as LHW. The eligible LHW will attend 2-days online training and 2-hours onsite visit or online workshop before delivering intervention to Chinese immigrant women. The time and the date of training and workshop will be finalized under mutual agreement. The effectiveness of the training programme will be evaluated by knowledge of cervical cancer and screening and competence of LHWs. For the knowledge of cervical cancer and screening, a 20 multiple choice questions in the written test will be used as pre-test and post-test. The passing mark is 16, 80% of total score. For competence evaluation, there are two parts for assessment including health talk and telephone follow-up. An author-developed checklist will be used. LHWs need to returndemonstrate how to deliver a health talk and telephone follow-up. LHWs require achieving at least 80% items in the checklist.Moreover, LHWs will be asked to complete an author-developed satisfactory survey after completion of training programme. In Phase III, a pilot wait-list randomized controlled study will be adopted. The feasibility and acceptability of the intervention and the preliminary effect of intervention on knowledge level, screening intention and Pap test uptake rate among Chinese immigrant women will be evaluated. The design of current pilot study is taking 40 participants in total sample size. Thus, 20 participants per group is a result. The eligible participants will be randomly assigned to either the intervention group or control group. The participants in the intervention group receive intervention first while participants in the wait-list control group receive delayed intervention after completion of data collection. The study will be conducted in three different community centers or associations where is the same centers of LHWs. Participants in this study will be recruited by convenience samplings. After screening the eligibility of applicants, research assistant 1 (RA1) will make appointment with participants to provide information sheet, sign written consent form and complete baseline data collection in person. RA1 communicates with LHWs and participants (intervention group) in the same center to arrange a health talk. LHWs will conduct 1 hour health talk and monthly telephone follow-up with navigation support for 2 months. Research assistant 2 (RA 2) will collect relevant data at T1 (1 month after delivering a health talk) and at T2 (3 months after post intervention received by intervention group) for all participants by using phone contact. All data or information will be collected by using a structured questionnaire in Simplified Chinese version or Traditional Chinese version. The parameters on feasibility such as screened potential participants, eligibility rate, consent rate, withdrawal rate and attrition rate among Chinese immigrant women will be calculated. The acceptability of intervention among participants will be evaluated by using author-developed satisfactory survey. To measure Pap test uptake rate among Chinese immigrant women, participants will be asked whether they have taken a Pap test within six months. Knowledge level of participants regarding cervical cancer and screening will be evaluated by using Cervical Cancer Screening Knowledge Scale. Screening intention will be evaluated by using a 5-point Likert Scale, from extremely unlikely to extremely likely. Data will be entered into IBM SPSS version 26.0 for analysis. 

纳入标准：

Inclusion criteria

排除标准：

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

Exclusion criteria：

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

研究实施时间：

Study execute time：

从 From 2021-09-05 00:00:00至 To 2022-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-10-25 00:00:00 至 To 2022-02-28 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 40

Group：

Two groups

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

HONG KONG

单位(医院)：

 Community centers 

单位级别：

  

Institution
hospital：

Community centers

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Pap test uptake

指标类型：

主要指标

Outcome：

Pap test uptake

Type：

Primary indicator

测量时间点：

before intervention, after health talk, 3 months after 2nd telephone follow up

测量方法：

questionnaire

Measure time point of outcome：

before intervention, after health talk, 3 months after 2nd telephone follow up

Measure method：

questionnaire

指标中文名：

Screening intention

指标类型：

次要指标

Outcome：

Screening intention

Type：

Secondary indicator

测量时间点：

before intervention, after health talk, 3 months after 2nd telephone follow up

测量方法：

questionnaire

Measure time point of outcome：

before intervention, after health talk, 3 months after 2nd telephone follow up

Measure method：

questionnaire

指标中文名：

Cervical cancer screening knowledge

指标类型：

次要指标

Outcome：

Cervical cancer screening knowledge

Type：

Secondary indicator

测量时间点：

before intervention, after health talk, 3 months after 2nd telephone follow up

测量方法：

questionnaire

Measure time point of outcome：

before intervention, after health talk, 3 months after 2nd telephone follow up

Measure method：

questionnaire

指标中文名：

Feasibility of the study

指标类型：

次要指标

Outcome：

Feasibility of the study

Type：

Secondary indicator

测量时间点：

after data collection

测量方法：

calculation

Measure time point of outcome：

after data collection

Measure method：

calculation

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

nil

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 25 岁 years
最大 Max age 100 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

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

Randomization Procedure (please state who generates the random number sequence and by what method)：

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

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

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.

Blinding：

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.

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

Nil

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

NIL

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

All information will be kept confidential all the time and only the research team can access to the encrypted data file in a password-locked personal computer. All hard copies of documents will be kept in a cabinet with a lock and will be destroyed within five years after completion of study. The electronic data will be deleted within five years after completion of study.Principal investigator and research team will be responsible for safekeeping of personal data during the after the study.All the personal data will be deleted and be threw in to confidential box.

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

All information will be kept confidential all the time and only the research team can access to the encrypted data file in a password-locked personal computer. All hard copies of documents will be kept in a cabinet with a lock and will be destroyed within five years after completion of study. The electronic data will be deleted within five years after completion of study.Principal investigator and research team will be responsible for safekeeping of personal data during the after the study.All the personal data will be deleted and be threw in to confidential box.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2021-10-19 03:49:45
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