Clinical trial NCT00890864: Pilot Study: Age Extension of NHS Breast Screening Programme
Official 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Routine Mammography
Keywords: Breast screening
Mammogram
Routine screening programme
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: NHS Cancer Screening Programmes
name: Department of Health, United Kingdom
First posted: 2009-04-30
Enrollment: 36000
Sex: FEMALE
Minimum age (years): 47
Maximum age (years): 73
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this pilot study is to assess the feasibility and acceptability of randomising the phasing-in of the age extension of the NHS Breast Screening Programme in six volunteer sites in different areas of England.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* female, and living in one of the 6 pilot areas, and
* aged 47-49 or 71-73 years, and
* in a screening invitation batch that includes their age group.

Primary outcomes:
measure: Screening uptake among women invited for screening in the extended age groups
timeFrame: One year
Secondary outcomes:
measure: Workload associated with inviting these new age groups for screening
timeFrame: One year
measure: Self-referrals among women in the pilot areas aged 47-49 or 71-73 but who were not invited for screening
timeFrame: One year
Other outcomes:
Locations:
Study officials:
affiliation: NHS Cancer Screening Programmes; also, Oxford University
name: Julietta Patnick, BA (Hons)
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.