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Behavioural Science Messages in Breast Cancer Screening

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Behavioural Message
Behavioural Message + Video
Usual Care Message
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring Breast Cancer Screening, Behavioural Science, Mobile Messaging, Behavioural Interventions, Healthcare Inequalities

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • NHS Breast Screening Hub

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Usual Care

Behavioural Message

Behavioural Message + Video

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Percentage uptake of 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.
Percentage uptake of breast cancer screening at three months- Per Protocol
Percentage uptake of breast cancer screening, three months after the initial invitation letter- per protocol

Secondary Outcome Measures

Percentage uptake of breast cancer screening, six months after the initial invitation letter
Percentage uptake of breast cancer screening, six months after the initial invitation letter both per protocol and intention-to-treat
Percentage uptake of breast cancer screening, three months after the initial invitation amongst those from sociodemographic groups (deprivation, ethnicity)
Percentage uptake of breast cancer screening, three months after the initial invitation letter amongst those from sociodemographic groups (deprivation, ethnicity)
Percentage uptake of breast cancer screening, three months after the initial invitation letter, amongst those given different invitation types.
Percentage uptake of breast cancer screening, three months after the initial invitation letter, amongst those given different invitation types.
Percentage uptake of breast cancer screening, three months after the initial invitation letter, amongst those with different screening history
Percentage uptake of breast cancer screening, three months after the initial invitation letter, amongst those with different screening history (non attendee, recurrent attendee, first-time invitee)

Full Information

First Posted
May 24, 2022
Last Updated
March 2, 2023
Sponsor
Imperial College London
Collaborators
NHS England (NHSE/I) London
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1. Study Identification

Unique Protocol Identification Number
NCT05395871
Brief Title
Behavioural Science Messages in Breast Cancer Screening
Official Title
Investigating the Use of Behavioural Science Informed Messages to Facilitate Attendance at Breast Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
July 15, 2022 (Actual)
Primary Completion Date
January 15, 2023 (Actual)
Study Completion Date
January 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
NHS England (NHSE/I) London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 trialled 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 channge 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 trialled. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Breast Cancer Screening, Behavioural Science, Mobile Messaging, Behavioural Interventions, Healthcare Inequalities

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
3 arm randomised controlled trial
Masking
Care Provider
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.
Allocation
Randomized
Enrollment
34047 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Behavioural Message
Arm Type
Experimental
Arm Description
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.
Arm Title
Behavioural Message + Video
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Behavioural Message
Intervention Description
Messaging involving increased salience, increasing positive emotions and information on health consequences
Intervention Type
Behavioral
Intervention Name(s)
Behavioural Message + Video
Intervention Description
Messaging as above. The video also includes information on emotional consequences, problem solving, anticipated regret, reducing negative emotions and credible source techniques.
Intervention Type
Other
Intervention Name(s)
Usual Care Message
Intervention Description
Standard usual care message involving link to non-behavioural science informed video
Primary Outcome Measure Information:
Title
Percentage uptake of breast cancer screening at three months- Intention to Treat
Description
Percentage uptake of breast cancer screening, three months after the initial invitation letter- intention to treat.
Time Frame
3 months
Title
Percentage uptake of breast cancer screening at three months- Per Protocol
Description
Percentage uptake of breast cancer screening, three months after the initial invitation letter- per protocol
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Percentage uptake of breast cancer screening, six months after the initial invitation letter
Description
Percentage uptake of breast cancer screening, six months after the initial invitation letter both per protocol and intention-to-treat
Time Frame
6 months
Title
Percentage uptake of breast cancer screening, three months after the initial invitation amongst those from sociodemographic groups (deprivation, ethnicity)
Description
Percentage uptake of breast cancer screening, three months after the initial invitation letter amongst those from sociodemographic groups (deprivation, ethnicity)
Time Frame
3 months
Title
Percentage uptake of breast cancer screening, three months after the initial invitation letter, amongst those given different invitation types.
Description
Percentage uptake of breast cancer screening, three months after the initial invitation letter, amongst those given different invitation types.
Time Frame
3 months
Title
Percentage uptake of breast cancer screening, three months after the initial invitation letter, amongst those with different screening history
Description
Percentage uptake of breast cancer screening, three months after the initial invitation letter, amongst those with different screening history (non attendee, recurrent attendee, first-time invitee)
Time Frame
3 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Registered with primary care physician as female and therefore will be invited to the breast cancer screening programme
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ara Darzi, FRCS
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
NHS Breast Screening Hub
City
Edgware
State/Province
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25668008
Citation
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.
Results Reference
background
PubMed Identifier
34624390
Citation
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.
Results Reference
background
PubMed Identifier
21513547
Citation
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.
Results Reference
background
Citation
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
Results Reference
background
PubMed Identifier
32610059
Citation
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.
Results Reference
background
PubMed Identifier
35854267
Citation
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.
Results Reference
derived

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Behavioural Science Messages in Breast Cancer Screening

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