Condition category
Cancer
Date applied
06/05/2011
Date assigned
06/05/2011
Last edited
29/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Alice Forster

ORCID ID

Contact details

Promoting Early Presentation Group
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
-
alice.s.forster@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

9553

Study information

Scientific title

Evaluation of service development in the NHS Breast Screening Programme: an intervention to promote early presentation in older women with breast cancer

Acronym

Evaluation of promoting early presentation service development

Study hypothesis

This study relates to a pilot of the implementation of a health promotion intervention to promote early presentation in older women with breast cancer. The intervention (the Promoting Early Presentation (PEP) Intervention) is delivered by a health professional to a woman aged 67+ attending for screening, after she has had her mammogram, and takes about 10 minutes. The aim of the PEP intervention is to equip women with the knowledge, skills, confidence and motivation to present promptly to their GPs on discovering breast symptoms, and thereby improve survival. The NHS Cancer Screening Programme has funded the pilot to offer the PEP Intervention to every woman attending for the current final round of screening (at age 67-70) in a number of breast screening services.

This study will evaluate this pilot in terms of health outcomes. The PEP Intervention has already been evaluated in a randomised controlled trial: it increases breast cancer awareness more than fourfold after two years compared with usual care. This evaluation is not intended, therefore, to determine the efficacy of the PEP Intervention itself, rather to measure the impact of the policy of offering the PEP Intervention to all eligible women on health outcomes in the routine clinical practice setting.

The main health outcome of interest is breast cancer awareness, measured before and after the pilot. To strengthen the design we will also measure breast cancer awareness at the same time in services not offering the PEP Intervention. This will provide the evidence needed to support decision making on whether the PEP Intervention should be implemented across the whole NHS Breast Screening Programme in England. This work is aligned with the National Awareness and Early Diagnosis Initiative (NAEDI).

Ethics approval

Cambridgeshire 1 Research Ethics Committee, First MREC approval date 16/11/2010, REC reference number 10/H0304/90

Study design

Non-randomised; Interventional; Design type: Prevention

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: National Cancer Research Network; Subtopic: Breast Cancer; Disease: Breast

Intervention

The main health outcome of interest is breast cancer awareness. Approaching 2500 women will allow us to detect a 5% percentage point difference (equivalent to just over a doubling) in the proportion who are breast cancer aware between implementation and comparison services with 90% power (assuming baseline proportion breast cancer aware of 4%, questionnaire response of 60%, 2-sided significance tests and significance level of 5%).

PEP Intervention : The PEP intervention is a scripted ten-minute one-to-one interaction between a screening radiographer (or screening assistant practitioner) and an older woman supported by a booklet, designed to be delivered during a routine appointment on the NHS Breast Screening Programme.

Follow Up Length: 48 month(s); Study Entry: Registration only

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Breast cancer awareness; Timepoint(s): Baseline, 6 months and 12 months

Secondary outcome measures

1. Cancer registrations; Timepoint(s): Yearly for 4 years post recruitment
2. General practitioner (GP) attendance; Timepoint(s): Baseline, 6 months and 12 months
3. Symptomatic breast clinic attendance; Timepoint(s): 3 years post recruitment

Overall trial start date

31/03/2011

Overall trial end date

30/03/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Women who were born in 1941, 1942 or 1943, attending for routine mammogram during 2011 at the breast screening services where the PEP Intervention is implemented (the implementation services)
2. Women who were born in 1941, 1942 or 1943, attending for routine mammogram during 2011 at the two breast screening services where the PEP Intervention is not implemented (the comparison services)

Target Gender: Female; Upper Age Limit 70 years; Lower Age Limit 67 years

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

Planned Sample Size: 2500; UK Sample Size: 2500

Participant exclusion criteria

1. Significant cognitive impairment
2. Insufficient understanding of the English language or language difficulties
3. Women presenting at their appointment with a breast symptom

Recruitment start date

10/05/2011

Recruitment end date

30/03/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Promoting Early Presentation Group
London
SE1 7EH
United Kingdom

Sponsor information

Organisation

Institute of Psychiatry (UK)

Sponsor details

Health Psychology Section
Guy's Campus
5th Floor
Guy House
St. Thomas Street
London
SE1 9RT
United Kingdom
-
jennifer.liebscher@kcl.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NHS Cancer Screening Programme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/23213334

Publication citations

Additional files

Editorial Notes