Pilot study: age extension of NHS Breast Screening Programme

ISRCTN	ISRCTN50037017
DOI	https://doi.org/10.1186/ISRCTN50037017
ClinicalTrials.gov (NCT)	NCT00890864
Protocol serial number	09/H0710/2
Sponsor	University of Oxford (UK)
Funder	NHS Breast Screening Programme National Office (UK)

Submission date: 16/01/2009
Registration date: 12/02/2009
Last edited: 31/07/2012

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

Not provided at time of registration

Contact information

Prof Julietta Patnick
Scientific

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

Study information

Primary study design	Interventional
Study design	Multicentre cluster randomised study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study objectives	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(s)	Added 29/05/2009: Approval obtained from Ealing and West London Research Ethics Committee in March 2009 (ref: 09/H0710/2)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	31/05/2010

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	36000
Key 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.
Key exclusion criteria	Does not comply with inclusion criteria
Date of first enrolment	01/05/2009
Date of final enrolment	31/05/2010

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

NHS Cancer Screening Programmes

Sheffield
S10 3TH
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes