Condition category
Not Applicable
Date applied
23/10/2018
Date assigned
20/12/2018
Last edited
11/01/2019
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

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

BIT

Sponsor details

4 Matthew Parker Street
Westminster
London
SW1H 9NP
United Kingdom
07490219701
daniel.gibbons@bi.team

Sponsor type

Industry

Website

https://www.behaviouralinsights.co.uk/

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

Publication citations

Additional files

Editorial Notes

11/01/2019: Internal review.