Evaluating the Age Extension of the NHS Breast Screening Programme

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Department of Health, United Kingdom
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT01081288
First received: March 3, 2010
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

Evaluating the net effects of extending the age range for breast screening in the NHS Breast Screening Programme in England from 50-70 years to 47-73 years


Condition Intervention
Breast Cancer Mortality
Other: Invitation for breast screening

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Evaluating the Net Effects of Extending the Age Range for Breast Screening in the NHS Breast Screening Programme in England From 50-70 Years to 47-73 Years

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Mortality from breast cancer by age 60 for women invited to have an additional early screen (before age 50) versus those not invited, and by age 80 for women invited to have an additional late screen (after age 70) versus those not invited [ Time Frame: 13 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breast cancer registrations in the screened and unscreened groups. A range of other medical outcomes, including screening outcomes in women invited for screening. [ Time Frame: 13 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000000
Study Start Date: March 2010
Estimated Study Completion Date: December 2026
Estimated Primary Completion Date: December 2026 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Women aged 47-49 invited for breast screening Other: Invitation for breast screening
Invitation for breast screening to women in different age groups
Active Comparator: Women aged 71-73 invited for breast screening Other: Invitation for breast screening
Invitation for breast screening to women in different age groups

Detailed Description:

Currently all women aged 50-70 are invited for breast screening every three years. In 2007 the Cancer Reform Strategy announced that from 2012 the NHS Breast Screening Programme (NHSBSP) would cover women aged 47-73. As capacity does not allow for full immediate roll out across the whole of England, this age extension is being phased-in with full coverage intended from 2012 although this may now be delayed due to slower than expected introduction of digital mammography.

To date there is limited evidence on the net benefit of extending (up or down) the age range for breast screening; no trial has looked at the added value of one extra screen within an existing screening programme.

This study will involve randomising the phasing-in of the age extension and collecting information on breast cancer incidence and mortality over the following 10 years. This will provide unbiased evidence on the net effects of extending the age range for breast screening. The findings have the potential to inform future screening policy in the UK and elsewhere.

As part of the routine breast screening programme, screening invitation batches are created of on average 1,000 women spanning ages 50 to 70 years, all living in the same geographical locality. In this study slightly larger batches will be created of women aged 47 to 73 years. These batches will be randomly allocated to one of two groups, that is, to include either women aged 47-70 or women aged 50-73 years. The study participants are the women aged 47-49 and 71-73 in these screening batches. All Breast Screening Units in England will participate in the study with the exception of a few using a non-standard method to invite women for screening.

The study builds on the pilot study (Pilot study of the feasibility and acceptability of randomising the phasing-in of the age extension of the NHS Breast Screening Programme in England. NCT00890864) which has been investigating the feasibility and acceptability of randomising the phasing-in of the age extension in several pilot sites.

In January 2011 the Department of Health announced in Improving Outcomes: A Strategy for Cancer that phasing-in of the age extension would continue over at least 2 three-year screening rounds (rather than one as originally planned). Thus recruitment of women will continue until at least 2016. As a result more women will now be included in the trial. The study design remains the same. As women are now being randomised until at least 2016 (rather than 2012) follow-up will continue at least until the late 2020s. In Dec 2010 North London Research Ethics Committee 3 gave written agreement for a) the trial to be extended for another 3 years and b) inclusion of data from the women in the pilot study (09/H0710/2) in this trial.

  Eligibility

Ages Eligible for Study:   47 Years to 73 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female,
  • aged 47-49 or 71-73 years, and in a Breast Screening Unit participating in the study.
  • All Breast Screening Units in England will participate in the study with the exception of a few that use a non-standard batch creation system.

Exclusion Criteria:

  • Anyone not satisfying the inclusion criteria
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01081288

Locations
United Kingdom
NHS Cancer Screening Programmes
Sheffield, United Kingdom, S10 3TH
Sponsors and Collaborators
University of Oxford
Department of Health, United Kingdom
Investigators
Principal Investigator: Julietta Patnick, BA(Hons) NHS Cancer Screening Programmes; also, Oxford University
  More Information

Additional Information:
No publications provided

Responsible Party: Heather House, Clinical Trials and Research Governance, Oxford University
ClinicalTrials.gov Identifier: NCT01081288     History of Changes
Other Study ID Numbers: 10/H0710/9
Study First Received: March 3, 2010
Last Updated: June 30, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Oxford:
Breast cancer
Breast screening
Mammography
Routine screening programme

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014