Condition category
Mental and Behavioural Disorders
Date applied
01/09/2016
Date assigned
06/09/2016
Last edited
24/11/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Lay summary under review with external organisation

Trial website

Contact information

Type

Public

Primary contact

Ms Isabelle Andresen

ORCID ID

Contact details

The Behavioural Insights Team
4 Matthew Parker Street
London
SW1H 9NP
United Kingdom

Type

Scientific

Additional contact

Mr Michael Sanders

ORCID ID

Contact details

The Behavioural Insights Team
4 Matthew Parker Street
London
SW1H 9NP
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2016065

Study information

Scientific title

Behaviorally informed invitation letters potential to increase breast screening attendance

Acronym

Study hypothesis

The purpose of trial is to address behavioural patient-centred barriers to breast screening uptake – such as insufficient knowledge about the test, underestimation of the risk of developing cancer, inertia and forgetfulness, or negative feelings associated with the test (fear of pain, of embarrassment, of positive results, etc.).

The key assumption is that a behaviourally- informed invitation letter, compared to standard letters, could increase attendance of routine breast screening appointments. Crucially, the proposed intervention does not interfere with women being able to make free informed choice of whether or not to get screened; it only aims to facilitate the attendance for those who already wish to do so, by removing behavioral obstacles.

Ethics approval

East Midlands Nottingham 1, ref: 16/EM/0413

Study design

Multi-centre three-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

No participant information sheet available.

Condition

Behavioural patient-centered barriers

Intervention

The intervention consists of adapting the invitation letter for routine breast cancer screening appointments sent to eligible women, registered at GP practices in the Greater Manchester area.

Randomization: Women who are due to receive a letter will be randomly assigned to one of the three arms of the trial, based on the middle three digits of each invitees’ NHS number. This process will be undertaken by Synertec, the company in charge of printing and sending out the invitation letters on behalf of the screening centres. Women will receive either the standard invitation letters that is currently sent by the screening services or one of the two new behaviourally informed letters.

The first intervention letter includes the cost to the NHS of missing a breast screening appointment and encourages women to let the screening service know if they cannot make their appointment. This is motivated by behavioural research showing that people are very sensitive to framing of particular outcome as a loss. In previous trials, including the cost of missed appointment to the NHS in text message reminders helped to significantly reduce non-attendance.

The second intervention letter includes a message which states the date that women from a particular GP practice are being booked appointments until. Behavioural research shows people are sensitive to the feeling of scarcity and limited time availability. Moreover, it has been shown that using a clear deadline helps solve procrastination and self-control problems.

The screening invitation contains all the relevant information about the appointment and of the three letters will be sent alongside the national breast screening leaflet which details the benefits and risks of breast screening, as well as any other information routinely send out by each of the screening services.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

The proportion of women who received appointment letters who go on to attend their appointments at the specified appointment date, time, and location, between when the trial commences and concludes.

Secondary outcome measures

The proportion of women who received appointment letters who go on to rearrange their appointments during the duration of trial

Overall trial start date

01/08/2016

Overall trial end date

01/06/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women
2. Aged between 50 and 70
3. Registered with a GP in the four above-mentioned Greater Manchester areas
4. Who are due to be invited for a breast screening appointment during the period of the trial
5. The trial also includes some women who are 48 and 49 or over 70. This is because some women within this age range are currently being invited to breast screening appointments, as part of a separate nationwide trial that is being run to test the value for money of screening for these other age groups

Participant type

Other

Age group

Adult

Gender

Female

Target number of participants

55000

Participant exclusion criteria

1. Women registered with a GP outside of one of the four Greater Manchester areas
2. Women in GM who are not due to be screened during the period of the trial or not registered with a GP practice
3. Women under 50 years old or over 70 (with the above-mentioned exception of those included within the other NHS trial to test age ranges)
4. Women already diagnosed with cancer and are currently undergoing treatment

Recruitment start date

25/09/2016

Recruitment end date

04/04/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

East Cheshire Trust
Victoria Rd
Macclesfield
SK10 3BL
United Kingdom

Trial participating centre

University Hospital of South Manchester
Southmoor Rd
Manchester
M23 9LT

Trial participating centre

Withington, Wigan, and Leigh Foundation Trust
Wigan Ln
Wigan
WN1 2NN
United Kingdom

Trial participating centre

Royal Bolton Foundation Trust
Minerva Rd
Bolton
BL4 0JR
United Kingdom

Sponsor information

Organisation

Greater Manchester Health & Social Care Partnership

Sponsor details

4th Floor
Three Piccadilly Place
Manchester
M1 3BN
United Kingdom

Sponsor type

Other

Website

Funders

Funder type

Government

Funder name

Greater Manchester Health & Social Care Partnership

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Results will be first summarized in a Internal Report. Eventually, these will be further disseminated via Conference Presentation, Publication on Website, Peer reviewed scientific journals.

Intention to publish date

01/05/2017

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/11/2016: Internal review.