Condition category
Pregnancy and Childbirth
Date applied
26/11/2017
Date assigned
25/06/2018
Last edited
22/06/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
In Taiwan, the Pap smear test for cervical cancer screening has been implemented since 1995, and previous research has shown that it can substantially decrease cervical cancer incidence and mortality (death) rates. However, the triennial participation rate has never reached 70% since this policy started in 1995, indicating that the methods of inviting people to attend the Pap smear test still have room to improve. The aim of this study is to evaluate the effectiveness of different invitation strategies.

Who can participate?
Women aged 30-69 who have not attended cervical cancer screening in the last three years

What does the study involve?
Participants are randomly allocated to receive either no intervention, a postcard invitation, a telephone call (reminding only), or a telephone call with scheduling appointment. The number of participants undergoing the Pap smear test within four months after the invitation is measured.

What are the possible benefits and risks of participating?
This program is expected to increase participation in cervical cancer screening. There are no risks of taking part in the study.

Where is the study run from?
Changhua County Public Health Bureau (Taiwan)

When is the study starting and how long is it expected to run for?
July 2008 to April 2009

Who is funding the study?
Health Promotion Administration, Ministry of Health and Welfare (Taiwan)

Who is the main contact?
Dr Sherry Yueh-Hsia Chiu

Trial website

Contact information

Type

Public

Primary contact

Dr Sherry Yueh-Hsia Chiu

ORCID ID

http://orcid.org/0000-0002-7207-7088

Contact details

Department of Health Care Management
College of Management
Chang Gung University
No. 259
Wen-Hwa 1st Road
333 Kwei-Shan
Tao-Yuan
333
Taiwan

Type

Public

Additional contact

Dr Yen-Po Yeh

ORCID ID

Contact details

No.162
Sec. 2
Jhongshan Rd
Changhua
500
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DOH97-HP-1505

Study information

Scientific title

Evaluating the community-based invitation strategies for cervical cancer screening participation: a randomised controlled trial

Acronym

Study hypothesis

The aim of this study is to evaluate the effectiveness of different invitation strategies on cervical screening participation based on a community-based approach.

Ethics approval

Ethics Committee of Chang Gung Memorial Hospital, 15/02/2016, ref: 104-9946B

Study design

Stratified randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Community

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Women aged 30-69 and pap smear screening overdue >=3 years

Intervention

Based on clinic visiting records in 2006 as hospital affiliation indicator, eligible women were stratified into three levels, including no record, 1-3 times, and 4 times or more of clinic visits in 2006, and then randomised by computer-generated random numbers to one of four invitation strategies for cervical cancer screening:
1. Non-invitation
2. Postcard
3. Telephone call reminding only
4. Telephone call with scheduling appointment

Outcomes are measured within 4 months since first date of invitation or sending postcard.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Number of women who participate in cervical screening within 4 months starting from first date of invitation, ascertained using the National Cervical Cancer Screening Registry System

Secondary outcome measures

There are no secondary outcome measures

Overall trial start date

01/07/2008

Overall trial end date

30/04/2009

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Women aged 30-69 lived in Changhua County
2. With/without pap smear screening overdue >=3 years

Participant type

Other

Age group

Adult

Gender

Female

Target number of participants

10000 women

Participant exclusion criteria

Women took pap smear within 3 years since last screening participation

Recruitment start date

01/10/2008

Recruitment end date

15/01/2009

Locations

Countries of recruitment

Taiwan

Trial participating centre

Changhua County Public Health Bureau
No.162, Sec. 2, Jhongshan Rd.
Changhua
500
Taiwan

Sponsor information

Organisation

Health Promotion Administration Ministry of Health and Welfare

Sponsor details

No.36
Tacheng Street
Datong Dist.
Taipei
103
Taiwan
+886 (0)2 25220888
yeh.leego@gmail.com

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Health Promotion Administration, Ministry of Health and Welfare, Taiwan (DOH97-HP-1505)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The trialists intend to publish this study on 30/10/2018.

IPD sharing statement
The current data with anonymization can be requested based on ethical committee review and approval.

Intention to publish date

30/10/2018

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes