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21 March 2013
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| [ Print-friendly version ] |
| Invitation reminder study |
| ISRCTN | ISRCTN02240458 |
| DOI | 10.1186/ISRCTN02240458 |
| ClinicalTrials.gov identifier | |
| EudraCT number | |
| Public title | Invitation reminder study |
| Scientific title | A randomised controlled trial of the effect of a breast screening appointment reminder letter on population uptake |
| Acronym | N/A |
| Serial number at source | 1 |
| 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. |
| Lay 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? The study started in November 2012 and is due to end by 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 |
| Ethics approval | Not provided at time of registration |
| Study design | Multicentre randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Breast cancer screening |
| Participants - inclusion criteria |
All women scheduled for invitation to their next breast screening appointment in Liverpool, South
Lancashire, and Bolton, Bury and Rochdale. |
| Participants - 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. |
| Anticipated start date | 01/11/2012 |
| Anticipated end date | 31/12/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 20,000 (10,000 in each arm) |
| Interventions |
There are no trial drugs or treatments associated with this trial.
Women in the intervention arm will be sent a reminder letter by post approximately seven days before their screening appointment. |
| Primary outcome measure(s) | An increase in attendance within 30 days of the first offered appointment |
| Secondary outcome measure(s) |
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. |
| Sources of funding | NHS Cancer Screening Programmes (UK) |
| Trial website | |
| Publications | |
| Contact name | Prof Stephen Duffy |
| Address |
Centre for Cancer Prevention
Wolfson Institute of Preventive Medicine Queen Mary University of London Charterhouse Square |
| City/town | London |
| Zip/Postcode | EC1M 6BQ |
| Country | United Kingdom |
| Tel | +44 (0)20 7882 3535 |
| Fax | +44 (0)20 7882 3890 |
| s.w.duffy@qmul.ac.uk | |
| Sponsor | Queen Mary University of London (UK) |
| Address |
Joint R&D Office
5 Walden Street |
| City/town | London |
| Zip/Postcode | E1 2EF |
| Country | United Kingdom |
| Tel | +44 (0)20 7882 7260 |
| sponsorsrep@bartshealth.nhs.uk | |
| Sponsor website: | http://www.bartsandthelondon.nhs.uk/our-services/research-and-development/ |
| Date applied | 22/10/2012 |
| Last edited | 11/01/2013 |
| Date ISRCTN assigned | 30/11/2012 |
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| © 2013 ISRCTN unless otherwise stated. | |
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