Plain English Summary
Trial website
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
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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