Extending the National Health Service (NHS) Breast Screening Age Range

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Department of Health, United Kingdom
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01081288
First received: March 3, 2010
Last updated: May 11, 2015
Last verified: May 2015
  Purpose

Nationwide cluster-randomised trial of extending the NHS breast screening age range in England


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: Nationwide Cluster-randomised Trial of Extending the NHS Breast Screening Age Range in England

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Breast cancer mortality [ Time Frame: 13 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Breast cancer incidence. Hospital admissions. Investigation, detection and treatment of breast lesions. Overall and cause-specific mortality. [ Time Frame: 13 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 3000000
Study Start Date: June 2009
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:

The NHS Breast Screening Programme routinely invites women aged 50-70 years to come for screening every three years. In 2007 the government decided that the age range for screening would be extended to 47-73 years. Funds were not available for immediate roll-out of screening to all women aged 47-73, and this trial was proposed and agreed. There is uncertainty about the effects of screening outside the 50-70 age range, and the aim of the trial is to assess reliably the risks and benefits of additional invitations for screening before age 50 and, separately, after age 70.

When the extension of breast screening to women aged 47-73 was announced in 2007 the intention was to offer breast cancer screening to all women in this age range after 2012, but in 2011 the date was changed to 2016 at the earliest. Subsequently, Public Health England (now responsible for all screening programmes in England) stated that future decisions about extending routine NHS breast cancer screening outside the age range 50-70 years should await the emergence of reliable evidence as to its effects. This trial can provide this information.

Randomisation of small groups (cluster randomisation) of trial participants determines which groups of women are offered one additional screening invitation before age 50 and which are not, and which groups of women are offered additional screening after age 70 and which are not. So for each separate age range the trial will be able to compare over the following years those women in the clusters invited for screening and those women in the clusters not invited for screening. Women will be followed up by linkage to NHS records, including cancer and hospital records, to assess the risks and benefits of the additional screening. It will take until at least the mid-2020s before results are known.

The findings will be monitored, analysed and reported as two entirely separate trials. One is a trial among younger women (randomly allocated at age 47-49 to additional screening invitation or control) of the effects of an extra screening invitation 3 years before routine screening would normally have begun. The other is a trial among older women (randomly allocated at age 71-73 to additional screening invitation or control) of the effects of an extra screening invitation among those who have had their final routine screening invitation.

The trial began in 2009 and eventually is likely to include at least two million women aged 47-49 and one million aged 71-73. It will involve about 71 of the 81 breast screening units in England. The units expected not to participate are mainly those using non-standard methods for inviting 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: ISRCTN50037017) which investigated in several pilot sites the feasibility and acceptability of randomising the phasing-in of the age extension.

  Eligibility

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

Inclusion Criteria:

  • Female, and
  • Aged 47-49 years or 71-73 years, and
  • In a Breast Screening Unit participating in the study. (All Breast Screening Units in England are expected to participate in the study with the exception of a few that use non-standard methods for creating screening batches).

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 NHS Cancer Screening Programmes; also, Oxford University
  More Information

Additional Information:
No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01081288     History of Changes
Other Study ID Numbers: 10/H0710/9
Study First Received: March 3, 2010
Last Updated: May 11, 2015
Health Authority: United Kingdom: Research Ethics Committee

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

ClinicalTrials.gov processed this record on June 28, 2015