Condition category
Cancer
Date applied
17/01/2020
Date assigned
23/01/2020
Last edited
23/01/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting
Publication status
Results overdue

Plain English Summary

Background and study aims
Cervical cancer is a highly preventable disease. To not attend an organized cervical cancer screening program increases the risk for cervical dysplasia and cervical cancer. The aim is to investigate the participation rate in three different intervention groups for non- attendees in the Swedish national program for cervical screening.

Who can participate?
Women who have not participated in the cervical cancer screening programme during the last six years if aged 30-49 and the last eight years if aged 50-64.

What does the study involve?
Women participating in the study are offered different methods for cervical cancer screening; a visit to a midwife for a Pap smear or an HPV self-test.

What are the possible benefits and risks of participating?
If women participate and dysplasia is detected it can be treated before it develops into cervical cancer.
We can not identify any risk of great importance.

Where is the study run from?
Faculty of Medicine and Health Sciences, Linköping University, Sweden.

When is the study starting and how long is it expected to run for?
April 2016 to December 2017.

Who is funding the study?
ALF Grants Region Östergötland, Sweden.

Who is the main contact?
Dr Caroline Lilliecreutz
caroline.lilliecreutz@regionostergtoland.se

Trial website

Contact information

Type

Scientific

Primary contact

Dr Caroline Lilliecreutz

ORCID ID

http://orcid.org/0000-0001-9491-9728

Contact details

Department of Obstetric and Gynaecology
Womens clinic
Plan 14
Universitets sjukhuset Linköping
Linköping
58185
Sweden
+46 708731124
caroline.lilliecreutz@regionostergtoland.se

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Participation in interventions and recommended follow-up for non-attendees in cervical cancer screening- taking the women's own preferred test method into account - a Swedish randomised controlled trial

Acronym

Study hypothesis

The participation rate will increase if the non-attendees can choose between different test methods presented by a midwife in a telephone call (an HPV self-test or Pap Smear in the clinic) or if they receive an HPV self-test directly by post for sampling rather than yearly invitations (routine procedure)

Ethics approval

Approved 12/04/2016, Regional Ethical Review Board in Linköping, Sweden (Etikprövningsmyndigheten, Box 2110, 750 02, Uppsala, Sweden; +46 10-475 08 00; registrator@etikprovning.se), ref: Dnr 2015/480-31

Study design

Single centre Interventional randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Not available in web format, please use contact detalis to request participant information sheet

Condition

Cervical cancer and cervix dysplasia

Intervention

Non-attendees are defined as women who had not participated in the cervical cancer screening programme during the last six years if aged 30 - 49, and the last eight years if aged 50 - 64. This strategy was in accordance with the Swedish age-differentiated screening intervals at that time. The population was defined as non-attendees living in the region of Östergötland, Sweden on March 8th 2016. Data are extracted from the Swedish national cervical cancer screening registry (NKCx) which has almost 100% coverage of invitations. The results of Pap smears and biopsies and variables can be extracted from the unique national social security number for each individual. The results from the HPV self-tests are extracted from a local registry in the clinic. Data concerning follow-up results are obtained until the 31st of December 2017 when the study period will end. The non-attendees’ addresses are obtained from the Swedish Population Register (SPR). The trial was not registered before the enrolment of participants started because it was not recommended by the Ethical board.

The non-attendees are randomly, 1:1:1, assigned to one of three different groups: telephone, HPV self-test, or control with no intervention except for the yearly invitations (routine procedure). The study groups are computer randomised and adjusted for area code and age by a statistician uninvolved in the study. All three groups received the yearly invitations. The first analysed sample, Pap smear or HPV test, in all groups is referred to as the index sample. We will consider that the different interventions had an effect if an HPV self-test is ever returned during the study period or a Pap smear is analysed within six months from the date a study invitation letter is sent. Non-attendees randomised to the telephone group are offered a choice of different sampling options. Invitation letters are posted between April 1st 2016 and 31st May 2017 (telephone) and September 30th 2017 (HPV self-test).

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Participation rate measured using patient records at six months after invitations were sent

Secondary outcome measures

1. Choice of intervention measured using patient records at the end of the study
2. Cytological diagnoses found in the index Pap smear at the time of analysis

Overall trial start date

08/03/2016

Overall trial end date

31/12/2017

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Non- attendees (defined as women who had not participated in the cervical cancer screening programme during the last six years if aged 30-49 and the last eight years if aged 50-64)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

10,614

Total final enrolment

10614

Participant exclusion criteria

All women 30-64 years old that had participated after the last invitation as recommended in the cervical cancer screening program

Recruitment start date

01/04/2016

Recruitment end date

30/09/2017

Locations

Countries of recruitment

Sweden

Trial participating centre

Linköping University
Department of Obstetrics and Gynaecology Division of Children's and Women's Health Faculty of Medicine and Health Sciences
Linköping
58185
Sweden

Sponsor information

Organisation

Linköping University Hospital

Sponsor details

Womens clinic plan 14
University Hospital
Linköping
581 85
Sweden
+46 70 5086031
elizabeth.nedstrand@regionostergotland.se

Sponsor type

Research organisation

Website

http://www.regionostergotland.se/

Funders

Funder type

Government

Funder name

ALF Grants Region Östergötland

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Publication in scientific paper during 2020. Presentation in congress and for staff.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request.

Intention to publish date

31/12/2020

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/01/2020: Trial’s existence confirmed by Regional Ethical Review Board in Linköping, Sweden