Condition category
Cancer
Date applied
16/01/2009
Date assigned
12/02/2009
Last edited
31/07/2012
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.cancerscreening.nhs.uk/breastscreen/

Contact information

Type

Scientific

Primary contact

Prof Julietta Patnick

ORCID ID

Contact details

NHS Cancer Screening Programmes
Fulwood House
Old Fulwood Road
Sheffield
S10 3TH
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00890864

Protocol/serial number

09/H0710/2

Study information

Scientific title

Pilot study of the feasibility and acceptability of randomising the phasing-in of the age extension of the NHS Breast Screening Programme in England

Acronym

Study hypothesis

Currently all women are invited for breast screening between the ages of 50 and 70. In 2007 the Cancer Reform Strategy announced that from 2012 the NHS Breast Screening Programme would be extended to cover women between the ages of 47 and 73. This means that all women will get two extra screening invitations in their lifetime. It also means that all women will get their first invitation before age 50. As capacity does not allow for full immediate roll out across the whole of England, the age extension will be phased-in with full coverage from 2012. Randomising this phasing-in would provide unbiased evidence on the extent to which it is beneficial to extend the age range for breast screening and whether an extra screen at younger or older ages is more worthwhile. To date there is no clear evidence on this as no trial has looked at the added value of one extra screen within an existing screening programme. This pilot study will assess the feasibility and acceptability of randomising the phasing-in of the age extension in six volunteer sites in different areas of England.

As of 29/05/2009 this record was updated to include amendments to the anticipated trial dates; the initial trial dates were as follows:
Initial anticipated start date: 01/03/2009
Initial anticipated end date: 31/03/2010

Ethics approval

Added 29/05/2009: Approval obtained from Ealing and West London Research Ethics Committee in March 2009 (ref: 09/H0710/2)

Study design

Multicentre cluster randomised study

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 screening

Intervention

As part of the routine breast screening process, the National Breast Screening System (NBSS) creates screening invitation batches of about 1,000 women spanning ages 50 - 70 years. In this pilot study the NBSS will create batches of about 1,000 women aged 47 - 73 years. These batches (clusters) will be randomly allocated to one of two groups, that is, to include ages 47 - 70 or ages 50 - 73 years, instead of, as now, 50 - 70 years. The randomisation will be done with equal (50/50) probability and no stratification. Study participants are the women aged 47 - 49 years and 71 - 73 years in the screening invitation batches that include their age group. There will be of the order of 100 such women in each batch and about 36,000 in total across the 6 pilot sites. Women aged 50 - 70 years will be unaffected by the randomisation process as they are in the age group already eligible for routine screening, and their invitations for screening will continue as normal. Women aged 47 - 49 years who are not invited for screening as part of the pilot study may request to be screened if they live in a pilot area. Women aged over 70 are already able to request screening every 3 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Screening uptake among women invited for screening in the extended age groups
2. Workload associated with inviting these new age groups for screening
3. Self-referrals among women in the pilot areas aged 47 - 49 years or 71 - 73 years but who were not invited for screening

Each of the pilot sites will be studied for up to 12 months. The measurement of the primary outcomes will be ongoing from soon after the start of the study. A final analysis and interpretation of the data will be conducted at the end of the study period.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/05/2009

Overall trial end date

31/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Study participants will be women living in one of the six pilot areas aged 47 - 49 years or 71 - 73 years and in a screening invitation batch that includes their age group.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

36,000

Participant exclusion criteria

Does not comply with inclusion criteria

Recruitment start date

01/05/2009

Recruitment end date

31/05/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Cancer Screening Programmes
Sheffield
S10 3TH
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

c/o Heather House
Clinical Trials and Research Governance
Manor House
John Radcliffe Hospital
Headington
Oxford
OX3 9DZ
United Kingdom

Sponsor type

University/education

Website

http://www.ox.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

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21852703

Publication citations

  1. Results

    Moser K, Sellars S, Wheaton M, Cooke J, Duncan A, Maxwell A, Michell M, Wilson M, Beral V, Peto R, Richards M, Patnick J, Extending the age range for breast screening in England: pilot study to assess the feasibility and acceptability of randomization., J Med Screen, 2011, 18, 2, 96-102, doi: 10.1258/jms.2011.011065.

Additional files

Editorial Notes