Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Self-sampling vs. reminder letter: A randomised controlled trial to investigate the effects on cervical cancer screening attendance and coverage
Acronym
Study hypothesis
Self-sampling is more efficient than a written reminder letter in improving cervical cancer screening attendance and coverage among current non-attendees
Ethics approval
This study was approved by the Ethical Committee in Hospital District of Helsinki and Uusimaa in March 2008 (ref: 430/E9/07 HUS). It was also approved by the City of Espoo.
Study design
Randomised open label controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Screening
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet.
Condition
Cervical cancer screening
Intervention
All non-participants after the primary cervical cancer screening invitation in the city of Espoo in years 2008 and 2009 received either a high-risk (hr) Human Papillomavirus (HPV) self-sampling test or a written reminder letter.
Both arms received an information letter on the study, information pamphlet on cervical cancer screening and HPV.
Participants in the self-sampling arm also received an informed consent sheet, Pantarhei Screener® self-sampling device (Panterhei Devices, Netherlands) and user instruction sheet on the use of the self-sampling test. Women to be screened were asked to use the sample within 2 weeks of its arrival and mail the sample within 24 hours of sample taking. Results of the screening test were promised within 2 months of the return.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Increase in attendance and coverage of cervical cancer screening
Secondary outcome measures
1. Prevalence of hrPV-infections higher among those women that do not participate cervical cancer screening after the primary invitation.
2. Feasibility, usability and acceptance of self-testing among women
Overall trial start date
01/11/2008
Overall trial end date
31/05/2010
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Women, ages 30-65, living in the city of Espoo who received an invitation to cervical cancer screening but did not take part.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
approximately 9000
Participant exclusion criteria
Address information for non-participants was updated from the Population Register Centre before the interventions were sent and women who had no address information available, were dead or living outside Espoo were excluded.
Recruitment start date
01/11/2008
Recruitment end date
31/05/2010
Locations
Countries of recruitment
Finland
Trial participating centre
Pieni Roobertinkatu 9
Helsinki
00130
Finland
Sponsor information
Organisation
Finnish Cancer Organisations (Finland)
Sponsor details
Pieni Roobertinkatu 9
Helsinki
00130
Finland
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Finnish Cancer Organisations (Finland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21752985
Publication citations
-
Results
Virtanen A, Nieminen P, Luostarinen T, Anttila A, Self-sample HPV tests as an intervention for nonattendees of cervical cancer screening in Finland: a randomized trial., Cancer Epidemiol. Biomarkers Prev., 2011, 20, 9, 1960-1969, doi: 10.1158/1055-9965.EPI-11-0307.