Condition category
Cancer
Date applied
20/10/2009
Date assigned
27/10/2009
Last edited
06/01/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.cptu.co.uk/outofhours

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

http://www.qmul.ac.uk/

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

  1. 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.

Additional files

Editorial Notes