Pilot Study: Age Extension of NHS Breast Screening Programme

• ClinicalTrials.gov Identifier: NCT00890864
• Recruitment Status: Completed
• First Posted: April 30, 2009
• Last Update Posted: July 19, 2010
• Sponsor: University of Oxford
• Collaborators: NHS Cancer Screening Programmes; Department of Health, United Kingdom
• Information provided by: University of Oxford

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Routine Mammography	Other: Invitation for breast screening	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 36000 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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 Start Date: May 2009
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Women aged 47-49 invited for breast screening	Other: Invitation for breast screening; Invitation for breast screening to women in different age groups; Other Name: Invitation for mammogram
Active Comparator: 2; Women aged 71-73 invited for breast screening	Other: Invitation for breast screening; Invitation for breast screening to women in different age groups; Other Name: Invitation for mammogram

Outcome Measures

Primary Outcome Measures :

1. Screening uptake among women invited for screening in the extended age groups [ Time Frame: One year ]

Secondary Outcome Measures :

1. Workload associated with inviting these new age groups for screening [ Time Frame: One year ]
2. Self-referrals among women in the pilot areas aged 47-49 or 71-73 but who were not invited for screening [ Time Frame: One year ]

Eligibility Criteria

• Ages Eligible for Study: 47 Years to 73 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Sponsors and Collaborators

University of Oxford

NHS Cancer Screening Programmes

Department of Health, United Kingdom

Investigators

• Principal Investigator: Julietta Patnick, BA (Hons); NHS Cancer Screening Programmes; also, Oxford University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Heather House, Clinical Trials and Research Governance, Oxford University
• ClinicalTrials.gov Identifier: NCT00890864
• Other Study ID Numbers: 09/H0710/2; ISRCTN50037017
• First Posted: April 30, 2009
• Last Update Posted: July 19, 2010
• Last Verified: July 2010

Keywords provided by University of Oxford:

Breast screening; Mammogram; Routine screening programme