NCT05395871

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34,047

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Jul 2022

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 24, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 27, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 15, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2023

Completed
2 years until next milestone

Results Posted

Study results publicly available

January 30, 2025

Completed
Last Updated

January 30, 2025

Status Verified

January 1, 2025

Enrollment Period

6 months

First QC Date

May 24, 2022

Results QC Date

April 3, 2023

Last Update Submit

January 6, 2025

Conditions

Keywords

Breast Cancer ScreeningBehavioural ScienceMobile MessagingBehavioural InterventionsHealthcare Inequalities

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    3 months

Secondary Outcomes (3)

  • No. of Participants Taking up Breast Cancer Screening, Three Months After the Initial Invitation Amongst Those From Sociodemographic Groups (Deprivation, 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.

    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

Study Arms (3)

Usual Care

ACTIVE COMPARATOR

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

Behavioural Message

EXPERIMENTAL

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

Behavioural Message + Video

EXPERIMENTAL

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

Interventions

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

Behavioural Message

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

Behavioural Message + Video

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

Usual Care

Eligibility Criteria

Age50 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsRegistered with primary care physician as female and therefore will be invited to the breast cancer screening programme
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged between 50 to 70 at the time of invitation
  • Lives within London screening region
  • Registered as female with primary care physician

You may not qualify if:

  • Previous attendance at breast screening in the current (3-year cycle)
  • Opted out of receiving text messages
  • Opted out of screening
  • Previous bilateral mastectomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NHS Breast Screening Hub

Edgware, London, United Kingdom

Location

Related Publications (7)

  • 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.

    PMID: 25668008BACKGROUND
  • 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.

    PMID: 34624390BACKGROUND
  • 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.

    PMID: 21513547BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 32610059BACKGROUND
  • 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.

  • 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.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Results Point of Contact

Title
Amish Acharya
Organization
Imperial College London

Study Officials

  • Ara Darzi, FRCS

    Imperial College London

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
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.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: 3 arm randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 24, 2022

First Posted

May 27, 2022

Study Start

July 15, 2022

Primary Completion

January 15, 2023

Study Completion

January 15, 2023

Last Updated

January 30, 2025

Results First Posted

January 30, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations