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Breast CancerNCT05395871

Behavioural Science Messages in Breast Cancer Screening

A study testing Behavioural Message and Behavioural Message + Video in people with Breast Cancer, run by Imperial College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 50 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Cancer
What is being tested?
Behavioural Message and Behavioural Message + Video
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34,047 participants
Where
1 siteUnited Kingdom
Study dates
15 Jul 2022to 15 Jan 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • NHS Breast Screening Hub

    Edgware, London

Other trials in United Kingdom

About this study

Official title: 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.

Read more

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.

Read the 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.

Conditions
Breast Cancer
Being tested
Behavioural Message, Behavioural Message + Video, Usual Care Message
Keywords
Breast Cancer Screening, Behavioural Science, Mobile Messaging, Behavioural Interventions, Healthcare Inequalities
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioural MessageBehavioural

    Messaging involving increased salience, increasing positive emotions and information on health consequences

  • Behavioural Message + VideoBehavioural

    Messaging as above. The video also includes information on emotional consequences, problem solving, anticipated regret, reducing negative emotions and credible source techniques.

  • Usual Care MessageOther

    Standard usual care message involving link to non-behavioural science informed video

Study groups in NCT05395871
Study groupRoleWhat they receive
Usual CareActive comparatorA 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.
Receives: Other: Usual Care Message
Behavioural MessageExperimentalA 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.
Receives: Behavioral: Behavioural Message
Behavioural Message + VideoExperimentalAn 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.
Receives: Behavioral: Behavioural Message + Video

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. No. of Participants Taking up Breast Cancer Screening at Three Months- Intention to Treat

    Percentage uptake of breast cancer screening, three months after the initial invitation letter- intention to treat.

    Measured: 3 months

  2. No. of Participants Taking up Breast Cancer Screening at Three Months- Per Protocol

    No. of participants taking up breast cancer screening, three months after the initial invitation letter- per protocol

    Measured: 3 months

Secondary outcomes (3)
  1. No. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Amongst Those From Sociodemographic Groups (Deprivation, Ethnicity)

    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).

    Measured: 3 months

  2. No. of Participants Taking up Uptake of Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those Given Different Invitation Types.

    No. of participants taking up breast cancer screening, three months after the initial invitation letter, amongst those given different invitation types.

    Measured: 3 months

  3. No. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those With Different Screening History

    No. of participants taking up breast cancer screening, three months after the initial invitation letter, amongst those with different screening history

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2022
  2. Study start15 Jul 2022
  3. Primary completion15 Jan 2023
  4. Study completion15 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Randomised
Intervention model
Parallel groups
Model description
3 arm randomised controlled trial
Masking
Single blind
Who is masked
Care provider
Enrolment
34,047 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05395871
Sponsor's protocol ID
22IC7498
Status last verified
Jan 2025
First submitted
24 May 2022
Last updated
30 Jan 2025
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 25668008
  • 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.

    PubMed 34624390
  • 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.

    PubMed 21513547
  • 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.

    PubMed 32610059
  • Acharya A, Darzi A, Judah G. An SMS and animated video intervention to increase uptake of breast cancer screening: a randomised controlled trial. Lancet. 2023 Nov;402 Suppl 1:S17. doi: 10.1016/S0140-6736(23)02133-5.

    PubMed 37997056
  • 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.

    PubMed 35854267

Questions about this trial

What is this clinical trial studying?

A study testing Behavioural Message and Behavioural Message + Video in people with Breast Cancer, run by Imperial College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

No. of Participants Taking up Breast Cancer Screening at Three Months- Intention to Treat (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05395871, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.

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