Condition category
Cancer
Date applied
22/10/2012
Date assigned
30/11/2012
Last edited
17/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Breast screening saves lives by detecting cancer earlier, which can make treatment more effective. This reduction in cancer deaths depends partially on women regularly attending their three-yearly routine screening appointments. Even though many women who do not attend will have made an informed decision, others will be in favour of screening but may have simply forgotten about the appointment. Women’s attendance at breast screening should be based on decisions about the likely benefits and risks of screening rather than on whether they remember their appointment. We are therefore carrying out a study to investigate whether a reminder letter sent by post to arrive close to a woman’s screening appointment increases attendance and whether this approach is cost-effective.

Who can participate?
Women living in Bolton, Bury and Rochdale, South Lancashire, and Liverpool will be entered into the study when they are invited to their routine three-yearly screening appointment.

What does the study involve?
One half of the women invited to their routine screening receive a reminder letter around two days before the screening appointment in addition to the normal invitation letter. The other group with only receive the standard invitation letter without any reminders.

What are the possible benefits and risks of participating?
This reminder letter was produced following consultation, including with lay people, to ensure that it contains only accurate information, and is non-coercive in tone. Women in the reminder group of the study who are in favour of screening but may have simply forgotten about the appointment will be reminded to either attend the appointment or call in and re-book. We do not anticipate any risks that may adversely affect the participants as a result of taking part in the trial.

Where is the study run from?
Centre for Cancer Prevention (CCP) at Barts and The London, Queen Mary University of London, UK

When is study starting and how long is it expected to run for?
November 2012 to December 2013

Who is funding the study?
National Health Service (NHS) - Cancer Screening Services

Who is the main contact?
Prof. Stephen Duffy
s.w.duffy@qmul.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Stephen Duffy

ORCID ID

Contact details

Centre for Cancer Prevention
Wolfson Institute of Preventive Medicine
Queen Mary University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom
+44 (0)20 7882 3535
s.w.duffy@qmul.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1

Study information

Scientific title

A randomised controlled trial of the effect of a breast screening appointment reminder letter on population uptake

Acronym

Study hypothesis

The aim of this study is to investigate whether sending an appointment reminder letter to women invited for routine breast screening improve appointment attendance.

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer screening

Intervention

Women in the intervention arm will be sent a reminder letter by post approximately seven days before
their screening appointment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

An increase in attendance within 30 days of the first offered appointment

Secondary outcome measures

Attendance within 90 days of the first offered appointment, secondly, within 180 days of the date the episode was opened, and thirdly, at the date and time of the first offered appointment.

Subgroup analyses will be performed and the cost per additional attendance will be calculated.

Overall trial start date

01/11/2012

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All women scheduled for invitation to their next breast screening appointment in Liverpool, South
Lancashire, and Bolton, Bury and Rochdale.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

20,000 (10,000 in each arm)

Participant exclusion criteria

1. Self referrals
2. Early re-calls
3. Women who are invited because of a higher risk of breast cancer
4. Women who have cancelled their appointment before the letter extract is generated and who do not re-book at a later stage are excluded as they will never appear in any of the letter extracts.

Recruitment start date

01/11/2012

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Mary University of London
London
EC1M 6BQ
United Kingdom

Sponsor information

Organisation

Queen Mary University of London (UK)

Sponsor details

Joint R&D Office
5 Walden Street
London
E1 2EF
United Kingdom
+44 (0)20 7882 7260
sponsorsrep@bartshealth.nhs.uk

Sponsor type

University/education

Website

http://www.bartsandthelondon.nhs.uk/our-services/research-and-development/

Funders

Funder type

Government

Funder name

NHS Cancer Screening Programmes (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/26784123

Publication citations

Additional files

Editorial Notes

17/05/2016: Publication reference added.