Condition category
Cancer
Date applied
13/02/2010
Date assigned
06/04/2010
Last edited
10/04/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Ahti Anttila

ORCID ID

Contact details

Pieni Roobertinkatu 9
Helsinki
00130
Finland

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 measures

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

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

http://www.cancer.fi

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21752985

Publication citations

  1. 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.

Additional files

Editorial Notes