NCT02872363

Brief Summary

Breast screening is a service offered by the NHS to help detect breast cancer and precancerous changes early at a time when treatment is more likely to be curative. An effective service must reach the 'at risk' but asymptomatic population. Breast screening uptake in London, consistently falls below the national target and is well below the national average. Uptake in West London is particularly low, with boroughs in Inner North West London having the some of lowest uptake rates in the country. Routine text message reminders have proven effective at improving uptake of breast screening appointments. However little attention is paid to the content of the messages. Previous studies of text message reminders in other clinical areas have shown that the content of these messages matters and some text messages are more effective than others. This protocol describes the design of a randomized controlled trial to investigate the effect of differently worded text messages on the engagement with breast screening in West London. Two intervention arms were designed taking into consideration results of a 1000 woman survey to highlight the behavioural barriers that most predict attendance. The survey tested 15 behavioural constructs and the two that most strongly predicted history of attendance were used to inform the text message content of the intervention arms for this trial. To this end, this randomised controlled trial (RCT) will test the current standard practice text message reminder against two intervention text message trial arms informed by the above described survey. The setting is West of London Breast Screening Service and women aged 47-73 who are due for screening will be randomized to receive one of the three trial arms. The primary outcome is the difference in uptake between trial arms. Further statistical analysis will analyse the difference in uptake by age group, deprivation score and previous attendance status. Result will inform how small changes to the word content may have significant effects on attendance at screening mammogram appointments.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7,944

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
terminated

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

July 19, 2016

Completed
21 days until next milestone

Study Start

First participant enrolled

August 9, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2017

Completed
Last Updated

April 11, 2019

Status Verified

April 1, 2019

Enrollment Period

3 months

First QC Date

July 19, 2016

Last Update Submit

April 9, 2019

Conditions

Keywords

breast screeningbreast cancermammogramuptakeremindertext messageSMS

Outcome Measures

Primary Outcomes (1)

  • Uptake of the timed appointment provided by the screening service

    Each patient is invited to an individual timed appointment. The outcome measure will be assessed based on if women attend their timed appointment. Usually this is within a month of the invitation letter being sent.

    Usually within a month (Individual timed appointment is provided by the screening service)

Secondary Outcomes (4)

  • Uptake of time appointment by age group

    Usually within a month (Individual timed appointment is provided by the screening service)

  • Uptake of timed appointment by number of previous invitations received

    Usually within a month (Individual timed appointment is provided by the screening service)

  • Uptake of timed appointment by history of attendance

    Usually within a month (Individual timed appointment is provided by the screening service)

  • Uptake of timed appointment by deprivation score

    Usually within a month (Individual timed appointment is provided by the screening service)

Study Arms (3)

Control

NO INTERVENTION

The current standard care text message reminder (SMS) that women routinely receive when being invited for their breast screening mammogram will be sent to the control group at 7 and 4 days before their timed appointment.

Intervention A - Behavioural Regulation

EXPERIMENTAL

Intervention A will be a text message reminder (SMS) containing a behavioural regulation message. Women will be sent this SMS at 7 and 4 days prior to their timed appointment.

Other: Intervention A - Behavioural Regulation

Intervention B - Priority

EXPERIMENTAL

Intervention B will be a text message reminder (SMS) containing a priority message. Women will be sent this SMS at 7 and 4 days prior to their timed appointment.

Other: Intervention B - Priority

Interventions

SMS reminder with 'Behavioural Regulation' message: 'Don't forget to make a diary note of your screening mammogram apt at (time)(date) at (site). Call 02033136644 to rearrange'

Intervention A - Behavioural Regulation

SMS reminder with 'Priority' message: 'Is your breast screening appointment on your priority list? Apt at (time), (date) at (site). Call 02033136644 to rearrange.'

Intervention B - Priority

Eligibility Criteria

Age20 Years - 100 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women who are eligible and due for breast screening in West London.

You may not qualify if:

  • Women who are not eligible for breast screening due to for example bilateral mastectomies.
  • Women who have chosen to not have screening and have informed the screening centre or their GP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Surgery and Cancer, St Mary's Campus, Praed Street, Imperial College London

London, W2 1NY, United Kingdom

Location

Related Publications (1)

  • Palmer MJ, Henschke N, Villanueva G, Maayan N, Bergman H, Glenton C, Lewin S, Fonhus MS, Tamrat T, Mehl GL, Free C. Targeted client communication via mobile devices for improving sexual and reproductive health. Cochrane Database Syst Rev. 2020 Jul 14;8(8):CD013680. doi: 10.1002/14651858.CD013680.

MeSH Terms

Conditions

Breast NeoplasmsBreast Diseases

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Sarah W Huf, MBBS BSc

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2016

First Posted

August 19, 2016

Study Start

August 9, 2016

Primary Completion

November 8, 2016

Study Completion

February 20, 2017

Last Updated

April 11, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

There is no intention to make individual participant data available. Data will be analysed at aggregate level.

Locations