Strategies for cervical cancer screening invitation

ISRCTN	ISRCTN11523089
DOI	https://doi.org/10.1186/ISRCTN11523089
Secondary identifying numbers	DOH97-HP-1505

Submission date: 26/11/2017
Registration date: 25/06/2018
Last edited: 02/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

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

Contact information

Dr Sherry Yueh-Hsia Chiu
Public

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

ORCID ID	0000-0002-7207-7088

Dr Yen-Po Yeh
Public

No.162, Sec. 2, Jhongshan Rd
Changhua
500
Taiwan

Study information

Study design	Stratified randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Evaluating the community-based invitation strategies for cervical cancer screening participation: a randomised controlled trial
Study objectives	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(s)	Ethics Committee of Chang Gung Memorial Hospital, 15/02/2016, ref: 104-9946B
Health condition(s) or problem(s) studied	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
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 study start date	01/07/2008
Completion date	30/04/2009

Eligibility

Participant type(s)	Other
Age group	Adult
Sex	Female
Target number of participants	10000 women
Key inclusion criteria	1. Women aged 30-69 lived in Changhua County 2. With/without pap smear screening overdue >=3 years
Key exclusion criteria	Women took pap smear within 3 years since last screening participation
Date of first enrolment	01/10/2008
Date of final enrolment	15/01/2009

Locations

Countries of recruitment

Taiwan

Study participating centre

Changhua County Public Health Bureau

No.162, Sec. 2, Jhongshan Rd.
Changhua
500
Taiwan

Sponsor information

Health Promotion Administration Ministry of Health and Welfare
Government

No.36
Tacheng Street
Datong Dist.
Taipei
103
Taiwan

Phone	+886 (0)2 25220888
Email	yeh.leego@gmail.com
"ROR"	https://ror.org/024w0ge69

Funders

Funder type

Government

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

No information available

Results and Publications

Intention to publish date	30/10/2018
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The trialists intend to publish this study on 30/10/2018.
IPD sharing plan	The current data with anonymization can be requested based on ethical committee review and approval.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol file		21/06/2018	02/04/2019	No	No

Additional files

ISRCTN11523089_PROTOCOL_21Jun2018.docx: Uploaded 02/04/2019

Editorial Notes

02/04/2019: Uploaded protocol (not peer reviewed).