Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Stephen Duffy
ORCID ID
Contact details
Cancer Research UK Centre for Epidemiology
Mathematics and Statistics
Wolfson Institute of Preventive Medicine
Barts and The London School of Medicine and Dentistry
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
N/A
Study information
Scientific title
A multicentre randomised controlled study of the effect of weekend and out-of-hours appointments on attendance rates at breast screening
Acronym
OOHS
Study hypothesis
The primary purpose of the study is to discover whether the offer of weekend or out of hours screening appointments alters attendance rates, and if so, which is better, working hours appointments, weekday evening appointments or weekend appointments.
Women in Manchester and Bristol who are due a routine breast screening appointment will be randomised to trial arms, in which they will receive letters inviting them to an appointment in weekday working hours, an evening, a Saturday, or working hours with the option to change to an evening or Saturday. The measured endpoints for comparison will be overall attendance rates and attendance at first offered appointment.
Ethics approval
Outer North East London Research Ethics Committee (REC) approved on the 15th March 2009 (ref: 09/H0701/96)
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 and prevention
Intervention
There are no trial drugs or treatments associated with this trial.
Women who are due to be invited for breast screening in Manchester and Bristol will be allocated, based on month of birth, to one of 6 groups. These will then be randomised in a ratio of 3:1:1:1 to the following conditions:
1. Usual invitation letter to a routine screening appointment within working hours
2. Invitation letter to a routine screening appointment within working hours, but with the option of changing to an appointment on a weekend or on a weekday evening
3. Invitation letter to a weekday evening screening appointment
4. Invitation letter to a weekend appointment
The time taken between sending letters and initial appointment is 5 weeks, if appointments are changed then those within 120 days will be counted. Therefore the maximum length of time the patient could be in the study is 155 days.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Attendance rate. Comparison will be made between the two major arms of the study, those with a working hours appointment offered, and those with an evening or weekend appointment. Attendance is defined as attending a screening appointment either at the time originally offered, or at an alternative appointment time within 120 days of the original. Data capture will include the appointment date and time offered, and the appointment date and time actually attended (if any).
Secondary outcome measures
1. Whether the invitee attended the first appointment offered, measured by whether the radiographer records on the NBSS system database that the patient attended the original appointment (5 weeks after the invitation letter was sent out)
2. Comparison of the attendance rates between the four groups for subsets of the invitees. In particular, we shall evaluate the effect of the non-standard appointments at prevalence screen and by age group, but will also look at effects on incidence screens, previous attenders and previous non-attenders. This will be assessed using the attendance data collected from the primary outcome, and compared between the patient subsets.
Overall trial start date
01/01/2010
Overall trial end date
01/01/2011
Reason abandoned
Eligibility
Participant inclusion criteria
All women (aged 47-73 at Manchester, 50-70 at Bristol, the age range which is eligible for the screening programme at these sites) scheduled for invitation in batches to their next breast screening appointment by the participating centres.
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
18,000
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/01/2010
Recruitment end date
01/01/2011
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cancer Research UK Centre for Epidemiology, Mathematics and Statistics
London
EC1M 6BQ
United Kingdom
Sponsor information
Organisation
Queen Mary University of London (UK)
Sponsor details
Research & Development Office
Queen Mary Innovations Centre
Lower Ground Floor
5 Walden Street
London
E1 2AN
United Kingdom
+44 (0)20 7882 7260
gerry.leonard@bartsandthelondon.nhs.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NHS Breast Screening Programme National Office (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
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23867998
Publication citations
-
Results
Offman J, Wilson M, Lamont M, Birke H, Kutt E, Marriage S, Loughrey Y, Hudson S, Hartley A, Smith J, Eckersley B, Dungey F, Parmar D, Patnick J, Duffy SW, A randomised trial of weekend and evening breast screening appointments., Br. J. Cancer, 2013, 109, 3, 597-602, doi: 10.1038/bjc.2013.377.