ISRCTN ISRCTN02240458
DOI https://doi.org/10.1186/ISRCTN02240458
Secondary identifying numbers 1
Submission date
22/10/2012
Registration date
30/11/2012
Last edited
17/05/2016
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

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

Contact information

Prof Stephen Duffy
Scientific

Centre for Cancer Prevention
Wolfson Institute of Preventive Medicine
Queen Mary University of London
Charterhouse Square
London
EC1M 6BQ
United Kingdom

Phone +44 (0)20 7882 3535
Email s.w.duffy@qmul.ac.uk

Study information

Study designMulticentre randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Other
Study typeScreening
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleA randomised controlled trial of the effect of a breast screening appointment reminder letter on population uptake
Study objectivesThe 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast cancer screening
InterventionWomen in the intervention arm will be sent a reminder letter by post approximately seven days before
their screening appointment.
Intervention typeOther
Primary outcome measureAn increase in attendance within 30 days of the first offered appointment
Secondary outcome measuresAttendance 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 study start date01/11/2012
Completion date31/12/2013

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants20,000 (10,000 in each arm)
Key inclusion criteriaAll women scheduled for invitation to their next breast screening appointment in Liverpool, South
Lancashire, and Bolton, Bury and Rochdale.
Key exclusion criteria1. 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.
Date of first enrolment01/11/2012
Date of final enrolment31/12/2013

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Queen Mary University of London
London
EC1M 6BQ
United Kingdom

Sponsor information

Queen Mary University of London (UK)
University/education

Joint R&D Office
5 Walden Street
London
E1 2EF
England
United Kingdom

Phone +44 (0)20 7882 7260
Email sponsorsrep@bartshealth.nhs.uk
Website http://www.bartsandthelondon.nhs.uk/our-services/research-and-development/
ROR logo "ROR" https://ror.org/026zzn846

Funders

Funder type

Government

NHS Cancer Screening Programmes (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 19/01/2016 Yes No

Editorial Notes

17/05/2016: Publication reference added.