Condition category
Cancer
Date applied
15/04/2009
Date assigned
29/05/2009
Last edited
25/09/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
The NHS Cervical Screening Programme has a target is to ensure that 4 out of 5 women are screened. However, it has been seen that this is not consistent throughout the population. In recent years, young women (under 30 years) have been showing a greater reluctance to attend for smears, due to fear of the examination.
A screening programme can only be successful if it covers a large proportion of the population coverage. It has been proven that those who do not attend are at higher risk of developing cervical cancer. As a result, any measure which would encourage women to take part would save lives and also would save the National Health Service (NHS) money, due to reduced costs of cancer treatment.

Who can participate?
3000 women, aged 25 – 64 years living in the Westminster Primary Care Trust (PCT) area, who have not responded to two cervical screening invitations.

What does the study involve?
Self−sampling means the woman can perform a test (using a swab, a bit like a long cotton bud) in the comfort
and privacy of her own home. We have already carried out studies which have shown that women of quite different educational levels find this easy to do without supervision, using a leaflet which we developed with the help of psychologists. There are around 16,000 women within Westminster PCT who have not responded to two invitations to come for a smear test. We propose to randomly select 3000 of them: half will just be sent a further invitation for a smear and the other half will be sent a self−sampling kit, together with information. We will compare the response rates, both to the initial screening test, and to follow up investigations, for those who have a positive test. A control group (will not receive a self−sampling kit) will simply be sent a third invitation to attend for a smear.

What are the possible benefits and risks of participating?
As these women have not previously attended for their cervical smears, they may benefit by having an
abnormality discovered before it becomes serious. They may also be reassured by having a normal result.

Where is the study run from?
Centre for Cancer Prevention, Wolfson Institute, Queen Mary University of London

When is study starting and how long is it expected to run for?
The study started in May 2009, and ended in May 2011.

Who is funding the study?
NIHR - Research for Patient Benefit Programme ref: PB-PG-0407-13358

Who is the main contact?
Dr Anne Szarewski
a.szarewski@qmul.ac.uk

Trial website

http://www.screening-study.org.uk

Contact information

Type

Scientific

Primary contact

Dr Anne Szarewski

ORCID ID

Contact details

Cancer Research UK
Centre for Epidemiology
Mathematics and Statistics
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
+44 (0)7831 840529
a.szarewski@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

The potential role of self-sampling in women who do not attend for cervical screening: a randomised controlled trial

Acronym

Study hypothesis

The NHS Cervical Screening Programme has stated that its target is to ensure that 80% of eligible women are screened. Although overall this target is being reached, it is recognised that uptake is not consistent throughout the population. In recent years, young women (aged under 30 years) have been showing a greater reluctance to attend for smears, with fear of the examination being cited as a factor.

A screening programme can only be successful if it achieves high population coverage, and it is well documented that those who do not attend are at higher risk of developing cervical cancer. Therefore any measure which would encourage such women to take part would save lives and also would save the NHS money, in terms of reducing costs of invasive cancer treatment.

Many women find having a cervical smear embarrassing and unpleasant, even among those who are willing to have them done. We know that around a quarter of the women who are invited to have a smear do not go for the test at all. There are various reasons for this, but important ones are the anticipation that the test will be embarrassing, may be performed by a man (they are not aware they can insist on a woman) and may be painful. Far from improving, in recent years attendance for screening appears to be falling, especially among women under 30 years.

Self-sampling means the woman can perform a test (using a swab, a bit like a long cotton bud) in the comfort and privacy of her own home, without the need for a speculum (which is the instrument used to open the vagina and which is responsible for the discomfort which may be felt). We have already carried out studies which have shown that women of quite different educational levels find this easy to do without supervision, using a leaflet which we developed with the help of psychologists. A study in the Netherlands has recently shown that a third of women who had not gone for a smear, did send back a self-sample. If we even got a fifth of women in the UK, who have not gone for their smear, to send in a self-sample, it would save lives and it would save the NHS money (because it costs much more to treat a cancer than to do smears and investigate abnormalities.

Ethics approval

St Mary's Research Ethics Committee (REC) approved on the 1st October 2008 (ref: 08/H0712/88)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Can be found at http://www.screening-study.org.uk/

Condition

Cervical cancer

Intervention

A randomised screening study with two groups allocated either to receive an invitation for a routine cervical smear or human papillomavirus (HPV) self-sampling test.
Control group: sent a further invitation letter for cervical screening and cervical screening survey
Study group: sent a self-sampling test kit and an invitation to take their own HPV sample and return it to the research group for processing. They will also be sent the cervical screening survey.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Comparison of the percentages of women responding to the invitation to return a self-sampling kit versus responding to an invitation for a cervical smear, measured 5 months from the beginning of recruitment.

Secondary outcome measures

1. Response to the invitation for further investigation following a positive test result (colposcopy for women with a smear showing mild dyskaryosis or above, smear +/- colposcopy for those with a positive HPV test), measured 14 months from the beginning of recruitment
2. Response to the request to return a survey regarding demographic information and reasons for previous non-attendance for screening, measured 12 months from the beginning of recruitment

Overall trial start date

15/05/2009

Overall trial end date

01/05/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women aged between 25 - 64 years
2. Eligible for routine cervical screening
3. Have not responded to two invitations to attend for smears

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

3000

Participant exclusion criteria

1. Women who have written to the primary care trust (PCT) to document their refusal to take part in the NHSCSP
2. Women who are not due routine screening as part of the NHSCSP
3. Pregnancy
4. Total abdominal hysterectomy
5. Never been sexually active

Recruitment start date

15/05/2009

Recruitment end date

01/05/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Cancer Research UK
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

18 - 26 Walden Street
Whitechapel
London
E1 2AX
United Kingdom
+44 (0)20 7882 7273
g.collins@qmul.ac.uk

Sponsor type

University/education

Website

http://www.qmul.ac.uk/

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) (ref: PB-PG-0407-13358)

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/21343937

Publication citations

  1. Results

    Szarewski A, Cadman L, Mesher D, Austin J, Ashdown-Barr L, Edwards R, Lyons D, Walker J, Christison J, Frater A, Waller J, HPV self-sampling as an alternative strategy in non-attenders for cervical screening - a randomised controlled trial., Br. J. Cancer, 2011, 104, 6, 915-920, doi: 10.1038/bjc.2011.48.

Additional files

Editorial Notes