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
- ISRCTN11523089_PROTOCOL_21Jun2018.docx Uploaded 02/04/2019