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Pilot Study: Age Extension of NHS Breast Screening Programme

This study has been completed.
Sponsor:
Collaborators:
NHS Cancer Screening Programmes
Department of Health, United Kingdom
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00890864
First received: January 26, 2009
Last updated: July 16, 2010
Last verified: July 2010
History of Changes
  Purpose

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 Intervention
Routine Mammography
 Other: Invitation for breast screening

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Mammography
U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Screening uptake among women invited for screening in the extended age groups [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Workload associated with inviting these new age groups for screening [ Time Frame: One year ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 36000
Study Start Date: May 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   47 Years to 73 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00890864

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

No publications provided by University of Oxford

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

Responsible Party: Heather House, Clinical Trials and Research Governance, Oxford University
ClinicalTrials.gov Identifier: NCT00890864     History of Changes
Other Study ID Numbers: 09/H0710/2, ISRCTN50037017
Study First Received: January 26, 2009
Last Updated: July 16, 2010
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
Breast screening
Mammogram
Routine screening programme

ClinicalTrials.gov processed this record on May 16, 2013