The Westminster self-sampling study for women who do not attend for cervical screening
| ISRCTN | ISRCTN40182307 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40182307 |
| ClinicalTrials.gov (NCT) | NCT00977392 |
| Protocol serial number | 1 |
| Sponsor | Queen Mary University of London (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) (ref: PB-PG-0407-13358) |
- Submission date
- 15/04/2009
- Registration date
- 29/05/2009
- Last edited
- 14/02/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
Cancer Research UK
Centre for Epidemiology, Mathematics and Statistics
Wolfson Institute of Preventive Medicine
Charterhouse Square
London
EC1M 6BQ
United Kingdom
| Phone | +44 (0)7831 840529 |
|---|---|
| a.szarewski@qmul.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | The potential role of self-sampling in women who do not attend for cervical screening: a randomised controlled trial |
| Study objectives | 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(s) | St Mary's Research Ethics Committee (REC) approved on the 1st October 2008 (ref: 08/H0712/88) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
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 |
| Completion date | 01/05/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 3000 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/05/2009 |
| Date of final enrolment | 01/05/2011 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
EC1M 6BQ
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 15/03/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/02/2020: ClinicalTrials.gov number added.
