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Behavioural Science Messages in Breast Cancer Screening

Investigating the Use of Behavioural Science Informed Messages to Facilitate Attendance at Breast Cancer Screening

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05395871
Enrollment
34047
Registered
2022-05-27
Start date
2022-07-15
Completion date
2023-01-15
Last updated
2025-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Breast Cancer Screening, Behavioural Science, Mobile Messaging, Behavioural Interventions, Healthcare Inequalities

Brief 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. 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.

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.

Interventions

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

BEHAVIORALBehavioural Message + Video

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

Sponsors

NHS England
CollaboratorOTHER_GOV
Imperial College London
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Caregiver)

Masking description

The screening services will not have access to the allocation of participants and will be masked. They will not be able to determine which messages are being sent to different women being invited to screen, as allocation will be undertaken by the third party messaging company following provision of a screening invitation list by the service.

Intervention model description

3 arm randomised controlled trial

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
No. of Participants Taking up Breast Cancer Screening at Three Months- Intention to Treat3 monthsPercentage uptake of breast cancer screening, three months after the initial invitation letter- intention to treat.
No. of Participants Taking up Breast Cancer Screening at Three Months- Per Protocol3 monthsNo. of participants taking up breast cancer screening, three months after the initial invitation letter- per protocol

Secondary

MeasureTime frameDescription
No. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Amongst Those From Sociodemographic Groups (Deprivation, Ethnicity)3 monthsNo. 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).
No. of Participants Taking up Uptake of Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those Given Different Invitation Types.3 monthsNo. of participants taking up 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 With Different Screening History3 monthsNo. of participants taking up breast cancer screening, three months after the initial invitation letter, amongst those with different screening history

Countries

United Kingdom

Participant flow

Participants by arm

ArmCount
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. Usual Care Message: Standard usual care message involving link to non-behavioural science informed video
11,748
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. Behavioural Message: Messaging involving increased salience, increasing positive emotions and information on health consequences
11,047
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. Behavioural Message + Video: Messaging as above. The video also includes information on emotional consequences, problem solving, anticipated regret, reducing negative emotions and credible source techniques.
11,252
Total34,047

Baseline characteristics

CharacteristicUsual CareTotalBehavioural Message + VideoBehavioural Message
Age, Customized
Open
58 years58 years57 years58 years
Age, Customized
Timed
59 years59 years59 years59 years
IMD Decile
IMD 1
160 Participants549 Participants214 Participants175 Participants
IMD Decile
IMD 10
625 Participants1732 Participants550 Participants557 Participants
IMD Decile
IMD 2
1108 Participants3108 Participants1008 Participants992 Participants
IMD Decile
IMD 3
1335 Participants3843 Participants1344 Participants1164 Participants
IMD Decile
IMD 4
1512 Participants4405 Participants1438 Participants1455 Participants
IMD Decile
IMD 5
1465 Participants4284 Participants1383 Participants1436 Participants
IMD Decile
IMD 6
1555 Participants4585 Participants1511 Participants1519 Participants
IMD Decile
IMD 7
1446 Participants4060 Participants1302 Participants1312 Participants
IMD Decile
IMD 8
1383 Participants3992 Participants1318 Participants1291 Participants
IMD Decile
IMD 9
1136 Participants3405 Participants1151 Participants1118 Participants
IMD Decile
Not stated
23 Participants84 Participants33 Participants28 Participants
Invitation Type (open/timed)
Open
8654 Participants25020 Participants8271 Participants8095 Participants
Invitation Type (open/timed)
Timed
3094 Participants9027 Participants2981 Participants2952 Participants
Race/Ethnicity, Customized
Ethnicity
Asian
1401 Participants4088 Participants1359 Participants1328 Participants
Race/Ethnicity, Customized
Ethnicity
Black
810 Participants2354 Participants786 Participants758 Participants
Race/Ethnicity, Customized
Ethnicity
Mixed
133 Participants391 Participants132 Participants126 Participants
Race/Ethnicity, Customized
Ethnicity
Not stated
5044 Participants14585 Participants4822 Participants4719 Participants
Race/Ethnicity, Customized
Ethnicity
Other
360 Participants1007 Participants335 Participants312 Participants
Race/Ethnicity, Customized
Ethnicity
White
4000 Participants11622 Participants3818 Participants3804 Participants
Region of Enrollment
United Kingdom
11748 participants34047 participants11252 participants11047 participants
Sex: Female, Male
Female
11748 Participants34047 Participants11252 Participants11047 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 11,7480 / 11,0470 / 11,252
other
Total, other adverse events
0 / 11,7480 / 11,0470 / 11,252
serious
Total, serious adverse events
0 / 11,7480 / 11,0470 / 11,252

Outcome results

Primary

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

Population: Timed invitation

ArmMeasureValue (NUMBER)
Usual CareNo. of Participants Taking up Breast Cancer Screening at Three Months- Intention to Treat2225 participants
Behavioural MessageNo. of Participants Taking up Breast Cancer Screening at Three Months- Intention to Treat2064 participants
Behavioural Message + VideoNo. of Participants Taking up Breast Cancer Screening at Three Months- Intention to Treat2137 participants
Primary

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

Population: Timed Appointments

ArmMeasureValue (NUMBER)
Usual CareNo. of Participants Taking up Breast Cancer Screening at Three Months- Per Protocol2073 participants
Behavioural MessageNo. of Participants Taking up Breast Cancer Screening at Three Months- Per Protocol1899 participants
Behavioural Message + VideoNo. of Participants Taking up Breast Cancer Screening at Three Months- Per Protocol1977 participants
Secondary

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

Population: Timed appointments

ArmMeasureGroupValue (NUMBER)
Usual CareNo. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Amongst Those From Sociodemographic Groups (Deprivation, Ethnicity)White1379 participants
Usual CareNo. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Amongst Those From Sociodemographic Groups (Deprivation, Ethnicity)Non- White1206 participants
Behavioural MessageNo. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Amongst Those From Sociodemographic Groups (Deprivation, Ethnicity)White1276 participants
Behavioural MessageNo. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Amongst Those From Sociodemographic Groups (Deprivation, Ethnicity)Non- White1194 participants
Behavioural Message + VideoNo. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Amongst Those From Sociodemographic Groups (Deprivation, Ethnicity)White1303 participants
Behavioural Message + VideoNo. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Amongst Those From Sociodemographic Groups (Deprivation, Ethnicity)Non- White1243 participants
Secondary

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

Population: Timed Appointment

ArmMeasureGroupValue (NUMBER)
Usual CareNo. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those With Different Screening HistoryFirst Time Invitee406 participants
Usual CareNo. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those With Different Screening HistoryNot First Time Invitee1820 participants
Behavioural MessageNo. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those With Different Screening HistoryFirst Time Invitee379 participants
Behavioural MessageNo. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those With Different Screening HistoryNot First Time Invitee1686 participants
Behavioural Message + VideoNo. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those With Different Screening HistoryFirst Time Invitee394 participants
Behavioural Message + VideoNo. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those With Different Screening HistoryNot First Time Invitee1743 participants
Secondary

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

Population: Open Invitations

ArmMeasureValue (NUMBER)
Usual CareNo. of Participants Taking up Uptake of Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those Given Different Invitation Types.4104 participants
Behavioural MessageNo. of Participants Taking up Uptake of Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those Given Different Invitation Types.3909 participants
Behavioural Message + VideoNo. of Participants Taking up Uptake of Breast Cancer Screening, Three Months After the Initial Invitation Letter, Amongst Those Given Different Invitation Types.3978 participants

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026