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
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
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