- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05395871
Behavioural Science Messages in Breast Cancer Screening
Investigating the Use of Behavioural Science Informed Messages to Facilitate Attendance at Breast Cancer Screening
Breast cancer is the most common cancer in the United Kingdom, with 1 in 8 women affected during their lifetime. Whilst survival rates are high, the 5-year survival rate is 72% higher with the earliest stage breast cancer, compared to the latest disease stage. The National Health Service Breast Screening Programme invites women aged 50 to 70 years old every three years to a mammogram. By enabling earlier detection, it is estimated that the National Health Service Breast Screening Programme saves 1300 lives per year.
Despite the potential benefits of breast cancer screening, attendance is falling. Behavioural Science is a field of study concerning understanding the processes underpinning human action. Behavioural theories, such as the Capability Opportunity Motivation-Behaviour model. Recent studies have shown the application of behavioural science to screening may also facilitate uptake of invitations. However, the use of plain text messages limits which behavioural determinants can be feasibly addressed, and what techniques can be used. Video messages can allow for more complex and a broader range of behavioural change techniques to be incorporated, and therefore have greater impact upon attendance.
Whilst behavioural science-informed messages have previously been trialed by groups to facilitate breast screening attendance, their effectiveness has been variable. One of the reasons for this, is that text messages are of limited length and formatting capability, thus restricting the number of behavioural change techniques that can be included. Moreover, some behavioural techniques are more complex than others, and plain text can limit the extent to which these can be feasibly incorporated. Video messaging provides a delivery mechanism that may enable more complex, and different combinations to be trialed. There is however, a paucity of data regarding the impact of sending a video-based behavioural science message upon attendance rates at breast cancer screening programmes. This study looks to investigate the impact of a video-message, compared to behavioural science-based text messages and standard reminder messages.
The primary object is to determine the impact of behavioural science informed (1) video and (2) text messages compared to usual care, upon uptake of breast cancer screening. Secondary objectives involve how this impact on attendance differs between population subgroups including people from differing demographic groups.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study will be conducted as a randomised control trial in the London screening region of the National Health Service Breast Screening Programme. The study will last over 6 months. The administrative hub for the National Health Service Breast Screening Programme. in London is based at the Royal Free Hospital, who will oversee invitation scheduling, message delivery and outcome data collation through their existing delivery systems.
Participants will be randomised using simple randomisation method in a 1:1:1 fashion to either intervention arm or usual care. Randomisation will utilise a computerised system in which each participant who is due for screening in the study period is randomly allocated a number corresponding to the message they will receive. This will be undertaken by the screening hub, and will be passed on to the message delivery service who will ensure the correct template is sent.
Written invitations are sent, as standard practice, by the National Health Service Breast Screening Programme. to invite women to either (1) an appointment at a set time, date and location (so-called timed invitations) or (2) to call and book an appointment (or open invitation). Following this, as part of usual care, those selected for open invitations will receive a first text message 7 days post written invitation. They will then receive two text message reminders, 7 days and 2 days prior to the appointment, once it has been booked. Those who receive timed invitations will just receive the two reminder messages, 7 and 2 days prior to the appointment. The decision to offer an individual a timed or open invitation is made by the screening service based on their pandemic recovery process, and will not be altered by this project.
This randomised controlled trial will involve randomising participants to receive the usual care messages (according to the timings outlined above), a plain text message incorporating or the behavioural message with a new link to a video incorporating more behavioural techniques.
The content of the intervention messages, and the video have been developed through extensive Patient and Public Involvement and Engagement work including 10 interviews, 2 focus groups and 2 co-design workshops. Members of the public have been consulted throughout the process, especially regarding the representations of individuals in the video, and the message content. The feedback received has been used to alter the materials, and further feedback received. Through this iterative approach we have ensured content is appropriate. We have also sought feedback from members of community groups working in mental health services specifically for African Caribbean and Arabic Speaking adults, and trans-led organisation to improve the quality of life of trans people, to ensure individuals from these groups are happy with representations. Screening commissioners at National Health Service England have also approved this content. The National Health Service Identity team have provided approvals for the use of National Health Service logos/branding, and the team at London Northwest Healthcare National Health Service Trust approved the use of their name.
The video will be hosted on a private page on the Imperial College London website, which will be available only to those who have been sent the link. The video will be translated into several languages, with voice overs also available in different languages, to ensure people from a diverse background are able to understand the content.
After 3 months from the initial written invitations, data will be collated from the breast screening hub regarding whether an individual attended an appointment and whether the messages were successfully sent. This will be repeated at 6 months corresponding to the key performance indicator of the service.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
London
-
Edgware, London, United Kingdom
- NHS Breast Screening Hub
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
The inclusion criteria will match those used by the National Health Service Breast Screening Programme, as all invitations will come directly from the programme, as per usual care. These include:
- Aged between 50 to 70 at the time of invitation
- Lives within London screening region
- Registered as female with primary care physician
The exclusion criteria will match those used by the National Health Service Breast Screening Programme, as all invitations will come directly from the programme, as per usual care. These include:
- Previous attendance at breast screening in the current (3-year cycle)
- Opted out of receiving text messages
- Opted out of screening
- Previous bilateral mastectomy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Usual Care
A text message sent 7 days prior then 48 hours before a booked/timed appointment.
The content of the message will be the 'usual care' content that is currently sent by the London Breast Cancer Screening Programme.
This includes a link to a YouTube hosted video.
|
Standard usual care message involving link to non-behavioural science informed video
|
|
Experimental: Behavioural Message
A text message sent 7 days prior then 48 hours before a booked/timed appointment.
The content of the message has been informed by previous co-design work, and incorporate behavioural change techniques.
This will include the same link to a YouTube hosted video, as the usual care arm.
|
Messaging involving increased salience, increasing positive emotions and information on health consequences
|
|
Experimental: Behavioural Message + Video
An text message sent 7 days prior then 48 hours before a booked/timed appointment.
The content of the message will be the same as the Behavioural text, however the link will be replaced with a weblink to an animated video.
This video has been designed through an extensive co-design process involving several behavioural change techniques designed to overcome barriers highlighted in this qualitative work.
|
Messaging as above.
The video also includes information on emotional consequences, problem solving, anticipated regret, reducing negative emotions and credible source techniques.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
No. of Participants Taking up Breast Cancer Screening at Three Months- Intention to Treat
Time Frame: 3 months
|
Percentage uptake of breast cancer screening, three months after the initial invitation letter- intention to treat.
|
3 months
|
|
No. of Participants Taking up Breast Cancer Screening at Three Months- Per Protocol
Time Frame: 3 months
|
No. of participants taking up breast cancer screening, three months after the initial invitation letter- per protocol
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
No. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Amongst Those From Sociodemographic Groups (Deprivation, Ethnicity)
Time Frame: 3 months
|
No. of participants taking up breast cancer screening, three months after the initial invitation letter amongst those from sociodemographic groups (ethnicity) Note there remain 3 trial arms (usual care, behavioural message, behavioural message + video), data represents subgroup analysis dichotomising these arms into white v. non white ethnicity). |
3 months
|
|
No. of Participants Taking up Uptake of Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those Given Different Invitation Types.
Time Frame: 3 months
|
No. of participants taking up breast cancer screening, three months after the initial invitation letter, amongst those given different invitation types.
|
3 months
|
|
No. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those With Different Screening History
Time Frame: 3 months
|
No. of participants taking up breast cancer screening, three months after the initial invitation letter, amongst those with different screening history
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ara Darzi, FRCS, Imperial College London
Publications and helpful links
General Publications
- Kerrison RS, Shukla H, Cunningham D, Oyebode O, Friedman E. Text-message reminders increase uptake of routine breast screening appointments: a randomised controlled trial in a hard-to-reach population. Br J Cancer. 2015 Mar 17;112(6):1005-10. doi: 10.1038/bjc.2015.36.
- Acharya A, Sounderajah V, Ashrafian H, Darzi A, Judah G. A systematic review of interventions to improve breast cancer screening health behaviours. Prev Med. 2021 Dec;153:106828. doi: 10.1016/j.ypmed.2021.106828. Epub 2021 Oct 5.
- Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.
- NHS Digital. Breast Screening Programme, England 2019-20 [Internet]. 2021 [cited 2021 Jun 14]. Available from: https://digital.nhs.uk/data-and-information/publications/statistical/breast-screening-programme/england---2019-20
- Huf S, Kerrison RS, King D, Chadborn T, Richmond A, Cunningham D, Friedman E, Shukla H, Tseng FM, Judah G, Darzi A, Vlaev I. Behavioral economics informed message content in text message reminders to improve cervical screening participation: Two pragmatic randomized controlled trials. Prev Med. 2020 Oct;139:106170. doi: 10.1016/j.ypmed.2020.106170. Epub 2020 Jun 29.
- Acharya A, Ashrafian H, Cunningham D, Ruwende J, Darzi A, Judah G. Evaluating the impact of a novel behavioural science informed animation upon breast cancer screening uptake: protocol for a randomised controlled trial. BMC Public Health. 2022 Jul 19;22(1):1388. doi: 10.1186/s12889-022-13781-x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22IC7498
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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