Condition category
Not Applicable
Date applied
05/10/2015
Date assigned
26/10/2015
Last edited
26/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Cervical screening, also called a smear test, is test used to check the health of the cervix (the neck of the womb). The test is used to detect any abnormal cells which could lead to cervical cancer if left untreated. In the UK, the NHS offers regular cervical screening to all women aged between 25 and 64. Women receive a letter from their local health service which invites them to book an appointment to have their cervical screening. Recent studies have shown that since the introduction of the cervical screening programme, there has been a reduction in the amount of women who develop cervical cancer. Unfortunately, many women do not attend the screening appointments especially in socially disadvantaged groups. A possible reason for this may be that the current invitation letter is over-complicated and unclear. The aim of this study is to find out whether simplified invitation letters could encourage more women to attend cervical screening.

Who can participate?
Women who live in the inner North East London region that are due to have cervical screening within the study period.

What does the study involve?
Participants are randomly allocated into three groups who receive a different letter inviting them for cervical screening. Those in the first group receive the current cervical screening invitation letter, which has been adapted from the national template for the local area. This letter contains a lot of background information, which is also included in the accompanying information leaflet, and does not include clear instructions about what the recipient needs to do. Those in the second group receive a shortened and simplified letter, which states exactly how the recipient needs to proceed. This letter also includes a fact about the risks of not having cervical screening (loss framed message). Those in the third group receive the same letter as in group 2, however instead of the loss framed message it includes a fact about the benefits of attending screening (gain framed message). Three months after the letters are sent, the amount of women who have attended a cervical screening appointment is recorded.

What are the possible benefits and risks of participating?
There are no specific benefits of participating although the shortened letter may encourage more women to attend cervical screening appointments. There are no risks of participating in the study.

Where is the study run from?
NHS Shared Business Service for North East London (UK)

When is the study starting and how long is it expected to run for?
April 2015 to June 2016

Who is funding the study?
Department of Health (UK)

Who is the main contact?
Miss Sarah Honeywell

Trial website

Contact information

Type

Scientific

Primary contact

Miss Sarah Honeywell

ORCID ID

Contact details

Department of Health
Richmond House
79 Whitehall
London
SW1A 2NS
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Does use of an invitation letter optimised based on behavioural insights increase uptake of cervical screening appointments? A randomised controlled trial study amongst women in North East London

Acronym

Study hypothesis

The aim of this study is to investigate whether changing the content of the cervical screening invitation letters increases take up of cervical screening.

Ethics approval

Cambridgeshire and Hertfordshire NRES Committee, 29/09/15, ref: 15/EE/0375

Study design

Single-centre randomised controlled trial with three arms.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Condition

Cervical cancer screening

Intervention

Participants are randomly allocated into three groups, who will each receive a different letter inviting them for cervical cancer screening.

Group 1 (Letter A): The control letter will be the current cervical screening invitation letter which is based on the national template and which has been adapted for the local area. The letter is quite long and contains a lot of contextual information, which is also provided in the information leaflet sent out alongside the letter. This means that the action that the woman who receives the letter needs to take (i.e. booking a cervical screening appointment) is not particularly clear.

Groups 2 (Letter B): The intervention letter has been shortened and simplified to only include essential information and to be more action-focused (i.e. focusing on prompting women to book a screening appointment). It also includes a loss framed message. Drawing attention to potential future losses can make the risks of a particular behaviour (i.e. not attending screening) more salient to an individual. The message in the letter is: "Every year over 700 women die in the UK from cervical cancer."

Group 3 (Letter C): The intervention letter has also been shortened and simplified as with Intervention 1, and this letter contains a gain framed message. Gain framed messages draw individual’s attentions to the potential gains of a particular behaviour (i.e. attending screening) making it appear more attractive. The message in the letter is: "Cervical screening saves 4,500 lives in England every year."

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The rate of attendance at a cervical screening appointment is measured using Exeter data system which records women’s attendance at cervical screening appointments three months after the letters are sent.

Secondary outcome measures

Whether demographics (age and deprivation) are related to attendance at a cervical screening appointment three months after the letters are sent. Age will be measured by date of birth and deprivation measured using the first half of the postcode and the Index of Multiple Deprivation (IMD) at lower super output area.

Overall trial start date

27/04/2015

Overall trial end date

17/06/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women of screening age (24.5-64)
2. Who live in the inner North East London region (which covers Newham, City and Hackney and Tower Hamlets)
3. Who are due for screening during the 9 week period of the trial as determined by their date of birth (for first screening appointment aged 24/25) or based upon the date of the previous screening (for all subsequent screening appointments)

Participant type

Mixed

Age group

Adult

Gender

Female

Target number of participants

Just under 27,000 women will be involved in the trial, and this will be split across the three conditions as follows: Control: 8,938 women, Intervention 1: 8,938 women, Intervention 2: 8,938 women

Participant exclusion criteria

1. Women not due a screening during the 9 week trial period
2. Women who have opted out of cervical screening by informing their GP
3. Women who have previously had a full hysterectomy or have informed their GP
4. Women living in other regions of London and England

Recruitment start date

19/10/2015

Recruitment end date

18/12/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Shared Business Service for North East London
8th Floor, 6 Mitre Passage Greenwich Peninsula
London
SE10 0ER

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NS
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Department of Health

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results will be shared with the local area NHS SBS and CCGs once data analysis is completed. Findings will also be published in a an academic journal.

Intention to publish date

31/12/2016

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes