Condition category
Cancer
Date applied
28/02/2017
Date assigned
28/02/2017
Last edited
16/10/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Public

Primary contact

Ms Kristina Londakova

ORCID ID

Contact details

The Behavioural Insights Team
4 Matthew Parker Street
London
SW1H 9NP
United Kingdom
+44 7729 016501
kristina.londakova@bi.team

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2017014

Study information

Scientific title

Behaviorally informed invitation letters potential to increase cervical screening attendance

Acronym

Study hypothesis

The aim of this study is to assess whether a behaviourally-informed invitation letter, compared to standard letters, could increase attendance of routine cervical screening appointments.

Ethics approval

Not provided at time of registration

Study design

Single-centre four-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

No participant information sheet available

Condition

Cervical cancer screening

Intervention

Women who are due to receive a letter will be randomly assigned to one of the three arms of the trial, based on the random middle three digits of each invitees’ NHS number. This process will be undertaken by CDIS, a department of Capita pls., specialising in the printing and distribution of postal communications the invitation letters on behalf of Primary Care Support England. Women will receive either the standard invitation letters that is currently sent or one of the three new behaviourally informed letters. All the intervention letters will be simplified to include only the key information (NB. the standard leaflets detailing the pros and cons will be attached). All the intervention letters will also include a visually attractive tear-off slip to encourage women’s planning, based the the successful experience from the ‘First Invitations to Breast Screen Victoria’ trial conducted by BIT in Australia.

The first intervention letter will contain loss-framed message and present the cervical screening as a detection behaviour.This is motivated by behavioural research showing when faced with a risky situation (such as illness detection), people may be more sensitive to a message stressing the potential losses associated with not performing a behaviour (e.g. ‘A failure to detect prostate cancer can cost a man his life’).

The second intervention letter will contain gain-framed message and present the cervical screening as a prevention behaviour. Behavioural research suggests that when faced with a riskless situation (sunscreen use, physical exercise), a gain framed message focussing on potential benefits of a behaviour may be more effective (e.g. ‘Regular exercise can help you prevent heart disease and stroke’).

The third intervention letter will contain an enhanced active choice message. The aim of active choice approach is to encourage people to actively make a decision in a binary choice. In other words, the idea is to remove the ease of inaction by presenting a lack of action as an active choice, as well. ‘Enhanced active choice’ method goes one step further - it not only reframes a situation as requiring an active choice but also makes the consequences (benefits and losses) of the options more salient.

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

Attendance rates at cervical screening appointments will be used to assess whether those who received the adapted letters (treatment groups) were more likely to attend their appointments, compared to those who received the standard
letter.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Attendance rate within 18 weeks of receiving an invitation letter of routine cervical screening appointments is assessed through medical record review.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

20/03/2017

Overall trial end date

01/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women
2. Aged between 25 and 64
3. Registered with a GP in Greater Manchester
4. Who are due to be invited for a breast screening appointment during the period of the trial

Participant type

All

Age group

Adult

Gender

Female

Target number of participants

125000

Participant exclusion criteria

1. Registered with a GP outside of Greater Manchester
2. In Greater Manchester who are not due to be screened during the period of the trial or not registered with a GP practice
3. Under 25 years old or over 64
4. Already diagnosed with cancer and are currently undergoing treatment

Recruitment start date

20/03/2017

Recruitment end date

31/07/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Greater Manchester Health and Social Care Partnership
3 Piccadilly Place
Manchester
M1 3BN
United Kingdom

Sponsor information

Organisation

Greater Manchester Health & Social Care Partnership

Sponsor details

3 Piccadilly Place
Manchester
M1 3BN
United Kingdom
+44 113 825 5346
siu-ann.pang@nhs.net

Sponsor type

Other

Website

Funders

Funder type

Other

Funder name

Greater Manchester Health and Social Care Partnership

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in an internal report, on BIT's website and potentially, in a high-impact peer reviewed journal, in 2018.

IPD Sharing plan:
For evaluation purposes, researchers will receive anonymised data from the screening centres, based on a mutual data sharing agreement. The data will not include information on patients' names, addresses, date of births or any information on medical conditions. During the study personal identifiable data will remain within GP practice and screening centre records (Capita on behalf of the Primary Care Support England). Personal data for the trial purposes will be collected and stored by the screening centre, in charge of sending letters and recording attendance at appointments. The researchers will only receive non-personal data, to be stored on secure hard drives accessible only to the staff of the Behavioural Insights Team (BIT).

Intention to publish date

31/12/2018

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

15/09/2017: Internal review. 06/06/2017: Internal review