An interventional study of Behavioural Message and Behavioural Message + Video in Breast Cancer, sponsored by Imperial College London. Completed at 1 site in United Kingdom. Open to female participants aged 50 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Imperial College London · Not applicable, Interventional, and 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.
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.
12,815 studies on the registry are indexed under Breast Neoplasms; 2,920 are open to participants now.
This study's enrollment of 34,047 is above the median of 72 across 9,494 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Imperial College London is the lead sponsor of 842 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
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:
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:
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.
Other: Usual Care 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.
Behavioral: Behavioural Message
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.
Behavioral: Behavioural Message + Video
Messaging involving increased salience, increasing positive emotions and information on health consequences
Messaging as above. The video also includes information on emotional consequences, problem solving, anticipated regret, reducing negative emotions and credible source techniques.
Standard usual care message involving link to non-behavioural science informed video
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.
Time frame: 3 months
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
Time frame: 3 months
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).
Time frame: 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.
No. of participants taking up 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 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
Time frame: 3 months
| Milestone | Usual Care | Behavioural Message | Behavioural Message + Video |
|---|---|---|---|
| Started | 11748 | 11047 | 11252 |
| Completed | 11748 | 11047 | 11252 |
| Not completed | 0 | 0 | 0 |
Percentage uptake of breast cancer screening, three months after the initial invitation letter- intention to treat.
| participants | Usual Care | Behavioural Message | Behavioural Message + Video |
|---|---|---|---|
| No. of Participants Taking up Breast Cancer Screening at Three Months- Intention to Treat | 2225 | 2064 | 2137 |
No. of participants taking up breast cancer screening, three months after the initial invitation letter- per protocol
| participants | Usual Care | Behavioural Message | Behavioural Message + Video |
|---|---|---|---|
| No. of Participants Taking up Breast Cancer Screening at Three Months- Per Protocol | 2073 | 1899 | 1977 |
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).
| participants | Usual Care | Behavioural Message | Behavioural Message + Video |
|---|---|---|---|
| White | 1379 | 1276 | 1303 |
| Non- White | 1206 | 1194 | 1243 |
No. of participants taking up breast cancer screening, three months after the initial invitation letter, amongst those given different invitation types.
| participants | Usual Care- Open | Behavioural Message- Open | Behavioural Message + Video- Open |
|---|---|---|---|
| No. of Participants Taking up Uptake of Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those Given Different Invitation Types. | 4104 | 3909 | 3978 |
No. of participants taking up breast cancer screening, three months after the initial invitation letter, amongst those with different screening history
| participants | Usual Care | Behavioural Message | Behavioural Message + Video |
|---|---|---|---|
| First Time Invitee | 406 | 379 | 394 |
| Not First Time Invitee | 1820 | 1686 | 1743 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | 0/11,748 (0%) | 0/11,748 (0%) | 0/11,748 (0%) |
| Behavioural Message | 0/11,047 (0%) | 0/11,047 (0%) | 0/11,047 (0%) |
| Behavioural Message + Video | 0/11,252 (0%) | 0/11,252 (0%) | 0/11,252 (0%) |
| Age, Customized(years) | Usual Care | Behavioural Message | Behavioural Message + Video | Total |
|---|---|---|---|---|
| Timed | 59 (53 to 64) | 59 (54 to 64) | 59 (54 to 64) | 59 (54 to 64) |
| Open | 58 (52 to 63) | 58 (53 to 63) | 57 (52 to 63) | 58 (52 to 63) |
| Sex: Female, Male(Participants) | Usual Care | Behavioural Message | Behavioural Message + Video | Total |
|---|---|---|---|---|
| Female | 11748 | 11047 | 11252 | 34047 |
| Male | 0 | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Usual Care | Behavioural Message | Behavioural Message + Video | Total |
|---|---|---|---|---|
| Ethnicity — White | 4000 | 3804 | 3818 | 11622 |
| Ethnicity — Black | 810 | 758 | 786 | 2354 |
| Ethnicity — Asian | 1401 | 1328 | 1359 | 4088 |
| Ethnicity — Mixed | 133 | 126 | 132 | 391 |
| Ethnicity — Other | 360 | 312 | 335 | 1007 |
| Ethnicity — Not stated | 5044 | 4719 | 4822 | 14585 |
| Region of Enrollment(participants) | Usual Care | Behavioural Message | Behavioural Message + Video | Total |
|---|---|---|---|---|
| United Kingdom | 11748 | 11047 | 11252 | 34047 |
| IMD Decile(Participants) | Usual Care | Behavioural Message | Behavioural Message + Video | Total |
|---|---|---|---|---|
| IMD 1 | 160 | 175 | 214 | 549 |
| IMD 2 | 1108 | 992 | 1008 | 3108 |
| IMD 3 | 1335 | 1164 | 1344 | 3843 |
| IMD 4 | 1512 | 1455 | 1438 | 4405 |
| IMD 5 | 1465 | 1436 | 1383 | 4284 |
| IMD 6 | 1555 | 1519 | 1511 | 4585 |
| IMD 7 | 1446 | 1312 | 1302 | 4060 |
| IMD 8 | 1383 | 1291 | 1318 | 3992 |
| IMD 9 | 1136 | 1118 | 1151 | 3405 |
| IMD 10 | 625 | 557 | 550 | 1732 |
| Not stated | 23 | 28 | 33 | 84 |
| Invitation Type (open/timed)(Participants) | Usual Care | Behavioural Message | Behavioural Message + Video | Total |
|---|---|---|---|---|
| Timed | 3094 | 2952 | 2981 | 9027 |
| Open | 8654 | 8095 | 8271 | 25020 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jul 2022 to primary completion in Jan 2023, 6 months.
Results were first posted in Jan 2025, 2 years after primary completion.
Of 2,272 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 69. This study's 6 months is below that.
Counting every sponsor, half of 2,345 studies reached it within 34 months; a quarter within 16 and three quarters within 69.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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