Self-sampling vs. reminder letter: effects on cervical cancer screening attendance and coverage
| ISRCTN | ISRCTN25346540 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25346540 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/02/2010
- Registration date
- 06/04/2010
- Last edited
- 10/04/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ahti Anttila
Scientific
Scientific
Pieni Roobertinkatu 9
Helsinki
00130
Finland
Study information
| Study design | Randomised open label controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet. |
| Scientific title | Self-sampling vs. reminder letter: A randomised controlled trial to investigate the effects on cervical cancer screening attendance and coverage |
| Study objectives | Self-sampling is more efficient than a written reminder letter in improving cervical cancer screening attendance and coverage among current non-attendees |
| Ethics approval(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/11/2008 |
| Completion date | 31/05/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | approximately 9000 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 31/05/2010 |
Locations
Countries of recruitment
- Finland
Study participating centre
Pieni Roobertinkatu 9
Helsinki
00130
Finland
00130
Finland
Sponsor information
Finnish Cancer Organisations (Finland)
Research organisation
Research organisation
Pieni Roobertinkatu 9
Helsinki
00130
Finland
| Website | http://www.cancer.fi |
|---|---|
"ROR" |
https://ror.org/05pgg4z49 |
Funders
Funder type
Research organisation
Finnish Cancer Organisations (Finland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2011 | Yes | No |
