Pilot Study: Age Extension of NHS Breast Screening Programme

NCT ID: NCT00890864

Last Updated: 2010-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Routine Mammography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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1

Women aged 47-49 invited for breast screening

Group Type ACTIVE_COMPARATOR

Invitation for breast screening

Intervention Type OTHER

Invitation for breast screening to women in different age groups

2

Women aged 71-73 invited for breast screening

Group Type ACTIVE_COMPARATOR

Invitation for breast screening

Intervention Type OTHER

Invitation for breast screening to women in different age groups

Interventions

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Invitation for breast screening

Invitation for breast screening to women in different age groups

Intervention Type OTHER

Other Intervention Names

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Invitation for mammogram

Eligibility Criteria

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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.
Minimum Eligible Age

47 Years

Maximum Eligible Age

73 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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NHS Cancer Screening Programmes

UNKNOWN

Sponsor Role collaborator

Department of Health, United Kingdom

OTHER_GOV

Sponsor Role collaborator

University of Oxford

OTHER

Sponsor Role lead

Responsible Party

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Clinical Trials and Research Governance, Oxford University

Principal Investigators

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Julietta Patnick, BA (Hons)

Role: PRINCIPAL_INVESTIGATOR

NHS Cancer Screening Programmes; also, Oxford University

References

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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.

Reference Type DERIVED
PMID: 21852703 (View on PubMed)

Other Identifiers

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ISRCTN50037017

Identifier Type: -

Identifier Source: secondary_id

09/H0710/2

Identifier Type: -

Identifier Source: org_study_id

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