NCT00890864

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 30, 2009

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

July 19, 2010

Status Verified

July 1, 2010

Enrollment Period

1 year

First QC Date

January 26, 2009

Last Update Submit

July 16, 2010

Conditions

Keywords

Breast screeningMammogramRoutine screening programme

Outcome Measures

Primary Outcomes (1)

  • Screening uptake among women invited for screening in the extended age groups

    One year

Secondary Outcomes (2)

  • 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

Study Arms (2)

1

ACTIVE COMPARATOR

Women aged 47-49 invited for breast screening

Other: Invitation for breast screening

2

ACTIVE COMPARATOR

Women aged 71-73 invited for breast screening

Other: Invitation for breast screening

Interventions

Invitation for breast screening to women in different age groups

Also known as: Invitation for mammogram
12

Eligibility Criteria

Age47 Years - 73 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

Study Officials

  • Julietta Patnick, BA (Hons)

    NHS Cancer Screening Programmes; also, Oxford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 26, 2009

First Posted

April 30, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

July 19, 2010

Record last verified: 2010-07