Plain English Summary
Background and study aims
Screening programmes have become widespread in developed countries, but how to improve uptake is an understudied area especially in deprived regions. This study aims to test whether it is possible to increase attendance rates for cervical and bowel screening in the deprived area of East and West Marsh, Grimsby, North East Lincolnshire by sending a behaviourally-informed reminder letter from GP practices to non-attenders and by entering people into a lottery, if they get screened.
Who can participate?
All patients of the recruited GP patients can participate if they are eligible for the relevant screening programmes (cervical or bowel cancer). Participants must have not booked and attended a previous screening appointment in the previous twelve months after being sent a letter.
What does the study involve?
Participants will be randomly assigned to one of three groups - either the control group, the letter group and the lottery and letter group. The control group will not receive any intervention. The letter group will receive a behaviourally informed letter. The lottery and letter group will receive the same letter, and will be offered the chance to win a lottery if they get screened. GP practices will then report back about who attended screenings following the study.
What are the possible benefits and risks of participating?
The benefits and risks are the same for the screening programmes themselves, and are discussed in more detail here: https://www.nhs.uk/conditions/bowel-cancer-screening/ and here: https://www.nhs.uk/conditions/cervical-screening/. There are no new benefits or risks to participants taking part in this study
Where is the study run from?
The study is run from the Behavioural Insights Team in London and will take place in 8 GP practices in North East Lincolnshire (UK)
When is the study starting and how long is it expected to run for? (what is the anticipated start date and the approximate duration of the trial?)
February 2018 to August 2019
Who is funding the study?
North East Lincolnshire (UK)
Who is the main contact?
Helen Brown (an advisor at the Behavioural Insights Team)
helen.brown@bi.team.
Trial website
Contact information
Type
Scientific
Primary contact
Mr Daniel Gibbons
ORCID ID
http://orcid.org/0000-0001-7869-5218
Contact details
4 Matthew Parker Street
London
SW1H 9NP
United Kingdom
07490219701
daniel.gibbons@bi.team
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2018123
Study information
Scientific title
Encouraging compliance with bowel and cervical cancer screening in previously non-compliant adults in the North Lincolnshire Area using a Behavioural Letter and a Letter and Lottery Combination
Acronym
Study hypothesis
We want to test the two following hypotheses:
1. In the context of deprived communities, a behaviourally-informed self-referral letter incorporating anticipated regret messaging is effective at promoting previous non-attenders to complete screening
2. In the context of deprived communities, incentivisation using a regret lottery with a behaviourally-informed self-referral letter incorporating anticipated regret messaging is effective at encouraging the uptake of screening
We will analyse these separately for bowel and cervical cancer, for a total of four primary study hypotheses.
We will also test the treatment arms against each other, which constitute 2 secondary hypotheses:
1. In the context of deprived communities, incentivisation using a regret lottery with a behaviourally-informed self-referral letter incorporating anticipated regret messaging is more effective at encouraging the uptake of cervical cancer screening than just a behaviourally-informed self-referral letter
2. In the context of deprived communities, incentivisation using a regret lottery with a behaviourally-informed self-referral letter incorporating anticipated regret messaging is more effective at encouraging the uptake of bowel cancer screening than just a behaviourally-informed self-referral letter
Ethics approval
The following ethics committees have been submitted to:
1. NHS Research Ethics Committee
2. Health Research Authority
3. PHE Screening Programmes Bowel Research Advisory Committee
4. PHE Cervical Research Advisory Committee
5. PHE Office for Data Release
Study design
Interventional three-armed randomised 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 contact details to request a participant information sheet.
Condition
Compliance with mass cancer screening programmes
Intervention
All participants will have either not attended a cervical cancer screening appointment, or not sent a bowel screening test back in the previous 12 months. Participants will be randomly allocated to one of three groups: the control arm which will receive no additional intervention, a letter-only arm who will receive a behavioural science informed letter and a lottery arm who will receive the same basic letter and be entered into a regret lottery.
Randomisation will be individual and will be a simple randomisation. Randomisation will be conducted by GP practices.
For all arms, we will monitor whether they book and attend an appointment (cervical cancer screening patients) or send back the screening kit (bowel cancer screening patients) 12 weeks after the letter is sent out (both arms receiving letters will be sent on the same day). There will be no follow-up.
GP practices are responsible for informing the investigators which people send their bowel cancer screening kits back, and which individuals attend a cervical cancer screening. Participants will be blind to the condition they are in, though GP practices will maintain a record of who is in what arm as they will be sending the letters to households.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Attendance at cervical cancer screening appointments within 12 weeks of the letter being sent for the cervical cancer group, measured using the date of booking and attending the appointment and reported by GP practices (if any)
2. Ordering and sending back a bowel cancer screening kit within 12 weeks of the letter being sent for the bowel cancer group and reported by GP practices (measured using the date of sending back the kit (if any)
Secondary outcome measures
N/A
Overall trial start date
01/02/2018
Overall trial end date
31/08/2019
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Eligible and sent a letter for but not attended a cervical cancer screening appointment OR not sent a bowel cancer screening test back in the previous twelve months.
2. Aged 18 years or older
3. Attending North Lincolnshire practices
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
3000
Participant exclusion criteria
N/A
Recruitment start date
01/04/2018
Recruitment end date
30/04/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
DR P SURESH BABU
Ladysmith Road North
Grimsby
DN32 9EF
United Kingdom
Trial participating centre
Open Door
Albion Street
Grimsby
DN32 7DL
United Kingdom
Trial participating centre
QUAYSIDE MEDICAL CENTRE
Albion St
Grimsby
DN32 7DY
United Kingdom
Trial participating centre
STIRLING MEDICAL CENTRE (MATHEWS)
Stirling Street
Grimsby
DN31 3AE
United Kingdom
Trial participating centre
HUMBERVIEW SURGERY
Stirling Medical Centre/Stirling St
Grimsby
DN31 3AE
United Kingdom
Trial participating centre
PELHAM MEDICAL GROUP
Church View Health Centre
Grimsby
DN31 1QZ
United Kingdom
Trial participating centre
THE ROXTON PRACTICE
Pilgrim Primary Care Centre, Pelham Road
Grimsby
DN40 1JW
United Kingdom
Trial participating centre
THE CHANTRY HEALTH GROUP
Church View Medical Centre, Cartergate
Grimsby
DN31 1QZ
United Kingdom
Sponsor information
Organisation
Behavioural Insights Team
Sponsor details
4 Matthew Parker Street
Westminster
London
SW1H 9NP
United Kingdom
07490219701
daniel.gibbons@bi.team
Sponsor type
Industry
Website
Funders
Funder type
Government
Funder name
Local Government Authority
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
North East Lincolnshire Council
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to publish the results only on the above hypotheses in a healthcare journal article.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are not expected to be made available as this is sensitive, personal data and we would not be able to get relevant permissions from GP clinics
Intention to publish date
31/12/2019
Participant level data
Not expected to be available
Basic results (scientific)
Publication list