Condition category
Cancer
Date applied
06/07/2020
Date assigned
04/08/2020
Last edited
04/08/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Annually, around 20% of new cervical cancer diagnoses in the UK occur in women aged 65 and over, and around 50% of the deaths. Most of these cases occur in women who are not adequately screened when aged 50-64. Smear tests can become uncomfortable with ageing and after the menopause and this can put some women off coming for cervical screening (previously known as ‘smear tests’). This is a problem because women who are not screened regularly are at higher risk of developing cervical cancer. One of the main causes of discomfort during a smear test is the speculum (the instrument used to hold the walls of the vagina open). There is another (newer) way we can do cervical screening which is by testing for the virus that causes cervical cancer; known as human papillomavirus (HPV) testing. HPV testing has introduced the possibility of new cervical screening approaches that are likely to be more acceptable to older women, as sampling from the cervix is not necessary and therefore samples can be collected without a speculum. In this study the researchers are offering two different options for non-speculum testing. The first option is a ‘speculum-free clinician test' taken by a practice nurse or GP. The second option is ‘self-test’ which the woman can collect herself in the comfort of her own home. Studies have shown that good quality samples are taken by both of these options and we believe that samples taken by either of these options will be as accurate as a standard screening test. The researchers want to find out if offering women the choice of having a cervical screening test without a speculum will increase screening uptake. They also want to find out how acceptable these tests are to women.

Who can participate?
Women aged 50-64 who are eligible for cervical screening who are at least 12 months overdue but have been screened at least once in the past 15 years according to their GP records (i.e. lapsed attenders at least 1 year overdue screening).

What does the study involve?
Women randomised to the intervention arm who choose to have a non-speculum vaginal sample by their GP or nurse will contact their GP practice to book an appointment where they will have the sample taken. Depending on the preferences of the GP practice, women will be able to book appointments in at least one of the following ways; by calling the practice (an EMIS alert will be set up to prompt the reception staff about the study), online via EMIS Web ‘Patient Access’ and by text messaging. Participants will also be asked to complete a short questionnaire to assess the acceptability of non-speculum sampling (non-speculum clinician sampling and self-testing) and future screening preferences. Women who are randomised to the control arm will receive the usual cervical screening reminder letter.

What are the possible benefits and risks of participating?
The benefit of taking part is that participants will have the opportunity to have cervical screening without a speculum. Women will also be contributing to research that will help improve cervical screening in the future. The researchers do not anticipate any risks associated with taking part in this study. Vaginal samples are routinely collected in the NHS.

Where is the study run from?
King's College London (UK)

When is the study starting and how long is it expected to run for?
May 2017 to November 2019

Who is funding the study?
Cancer Research UK

Who is the main contact?
Jane Rigney
jane.rigney@kcl.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Jane Rigney

ORCID ID

Contact details

King's College London
Faculty of Life Sciences & Medicine
London
SE1 9RT
United Kingdom
+44 (0)2078485494
jane.rigney@kcl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CPMS 38979, IRAS 242943

Study information

Scientific title

A pilot study to assess the feasibility and acceptability of offering cervical screening without a speculum to increase uptake in lapsed attenders aged 50-64

Acronym

SHOW2

Study hypothesis

Offering women the choice of having a cervical screening test without a speculum will increase screening uptake and is acceptable to women.

Ethics approval

Approved 17/07/2018, London - Stanmore Research Ethics Committee, Ground Floor (NRES/HRA, 80 London Road, London, SE1 6LH, UK; +44 (0)20 7972 2561; stanmore.rec@hra.nhs.uk), REC ref: 18/LO/1175

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

Cervical screening

Intervention

This is a pilot study in primary care which will involve 10-12 GP practices within the Barts Health Catchment area. Eligible women are randomised by the GP practice using computer-generated random numbers (provided by the study team) in a ratio of 1:1 to either the intervention or control arm:
1. Intervention arm - a letter offering the choice of:
1.1. Booking an appointment with their GP or nurse for a non-speculum clinician sample or
1.2. Ordering a self-sampling kit
OR
2. Control arm - Usual cervical screening reminder letter

There is another (newer) way we can do cervical screening which is by testing for the virus that causes cervical cancer; known as human papillomavirus (HPV) testing. HPV testing has introduced the possibility of new cervical screening approaches that are likely to be more acceptable to older women, as sampling from the cervix is not necessary and therefore samples can be collected without a speculum.

In this study the researchers are offering two different options for non-speculum testing. The first option is a ‘speculum-free clinician test' taken by a practice nurse or GP. The second option is ‘self-test’ which the woman can collect herself in the comfort of her own home. Studies have shown that good quality samples are taken by both of these options and we believe that samples taken by either of these options will be as accurate as a standard screening test.

The researchers want to find out if offering women the choice of having a cervical screening test without a speculum will increase screening uptake. They also want to find out how acceptable these tests are to women. Duration of follow up was 12 months

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Cervical screening uptake: the proportion of women screened (according to GP records) at 4 months from randomisation

Secondary outcome measures

1. Cervical screening uptake measured using GP records at 12 months (i.e. long-term cervical screening coverage)
2. Acceptability of non-speculum sampling approaches for cervical screening among women aged 50-64 who are lapsed attendees, assessed using a patient questionnaire data at the time they take the sample
3. The proportion of women who undergo clinician-taken sampling without a speculum versus the proportion who request and return a self-sample, measured using data received from the lab (the number who undergo clinician-taken sampling without a speculum and number who return a self-sample) and coordinating centre data (the number who request a kit) at the end of the study (once data is collected and clean).
4. The proportion of eligible women who test HPV positive and a) attend for follow up (cytology or colposcopy) within 6 months of testing HPV positive on a non-speculum sample and b) who are treated for CIN2+, measured using GP record data at end of the study (once data is collected and clean).
5. Acceptability of non-speculum sampling for cervical screening among the clinical staff who took non-speculum samples from eligible women at GP practices participating in this study, assessed using a swab-taker questionnaire at the end of the study (once recruitment is complete)

Overall trial start date

01/05/2017

Overall trial end date

15/11/2019

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Lapsed cervical screening attenders (i.e. at least 12 months overdue but have attended at least once in the past 15 years)

Participant type

Patient

Age group

Other

Gender

Female

Target number of participants

700

Participant exclusion criteria

Women unable to provide informed consent

Recruitment start date

15/08/2018

Recruitment end date

15/11/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

XX Place Health Centre
Alderney Building Mile End Hospital Site Bancroft Road
London
E1 4DG
United Kingdom

Trial participating centre

Blithehale Medical Centre
22 Dunbridge St
London
E2 6JA
United Kingdom

Trial participating centre

Albion Health Centre
333 Whitechapel Rd Shadwell
London
E1 1BU
United Kingdom

Sponsor information

Organisation

King's College London

Sponsor details

Faculty of Life Sciences & Medicine
London
SE1 9RT
United Kingdom
+44 (0)2078485494
jane.rigney@kcl.ac.uk

Sponsor type

University/education

Website

http://www.kcl.ac.uk/index.aspx

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

Funding Body Type

unknown

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The researchers are currently preparing a manuscript for peer-reviewed publication.

IPD sharing statement
The datasets generated during and/or analysed during the current study are not expected to be made available. The dataset will be held at KIng's College London for 6 years after the study has finished.

Intention to publish date

01/12/2020

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/08/2020: Uploaded protocol (not peer reviewed) Version 3.0 18 Mar 2019. 21/07/2020: Trial's existence confirmed by London - Stanmore Research Ethics Committee.