Pilot Study: Age Extension of NHS Breast Screening Programme

Study Overview
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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.

Official Title
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Pilot Study of the Feasibility and Acceptability of Randomising the phasing-in of the Age Extension of the NHS Breast Screening Programme in England

Conditions
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Routine Mammography

Intervention / Treatment
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* Other: Invitation for breast screening


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 47 Years
Maximum Age: 73 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Women aged 47-49 invited for breast screening | Other: Invitation for breast screening<br>* Invitation for breast screening to women in different age groups<br>* Other names: Invitation for mammogram;|
| Active Comparator: 2<br>Women aged 71-73 invited for breast screening | Other: Invitation for breast screening<br>* Invitation for breast screening to women in different age groups<br>* Other names: Invitation for mammogram;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Screening uptake among women invited for screening in the extended age groups |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Workload associated with inviting these new age groups for screening |  | One year | 
| Self-referrals among women in the pilot areas aged 47-49 or 71-73 but who were not invited for screening |  | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast screening, Mammogram, Routine screening programme