Evaluation of service development in the NHS Breast Screening Programme
| ISRCTN | ISRCTN50630133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50630133 |
| Secondary identifying numbers | 9553 |
- Submission date
- 06/05/2011
- Registration date
- 06/05/2011
- Last edited
- 25/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Alice Forster
Scientific
Scientific
Promoting Early Presentation Group
249 Westminster Bridge Road
London
SE1 7EH
United Kingdom
| alice.s.forster@kcl.ac.uk |
Study information
| Study design | Non-randomised; Interventional; Design type: Prevention |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Evaluation of service development in the NHS Breast Screening Programme: an intervention to promote early presentation in older women with breast cancer |
| Study acronym | Evaluation of promoting early presentation service development |
| Study objectives | 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(s) | Cambridgeshire 1 Research Ethics Committee, First MREC approval date 16/11/2010, REC reference number 10/H0304/90 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 31/03/2011 |
| Completion date | 30/03/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Female |
| Target number of participants | Planned Sample Size: 2500; UK Sample Size: 2500 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/05/2011 |
| Date of final enrolment | 30/03/2012 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Promoting Early Presentation Group
London
SE1 7EH
United Kingdom
SE1 7EH
United Kingdom
Sponsor information
Institute of Psychiatry (UK)
University/education
University/education
Health Psychology Section
Guy's Campus
5th Floor, Guy House, St. Thomas Street
London
SE1 9RT
England
United Kingdom
| jennifer.liebscher@kcl.ac.uk | |
"ROR" |
https://ror.org/0220mzb33 |
Funders
Funder type
Government
NHS Cancer Screening Programme (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2012 | Yes | No | |
| Plain English results | 25/10/2022 | No | Yes |
Editorial Notes
25/10/2022: Cancer Research UK plain English results link added.
