Condition category
Cancer
Date applied
06/08/2007
Date assigned
03/10/2007
Last edited
31/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Lindsay Forbes

ORCID ID

Contact details

Guy's Campus
9th Floor
Capital House
42 Weston Street
London
SE1 3QD
United Kingdom
+44 (0)20 7848 6216
lindsay.forbes@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PEP (Promoting Early Presentation)

Study hypothesis

The supplementation of optimised usual care with one of two variants of a radiographer-delivered psycho-education intervention will be more effective than optimised usual care alone in improving women's knowledge and confidence to present promptly with breast symptoms.

Review of the evidence available in http://www.ncbi.nlm.nih.gov/pubmed/15992567

Ethics approval

Approval received from King's College Hospital Research Ethics Committee on the 18th April 2007 (LREC Ref: 07/Q0703/51).

Study design

Three-arm multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Condition

Breast cancer

Intervention

All three groups will receive optimised usual care, i.e., a reminder that they are no longer eligible for routine breast screening but may continue to request further breast screening themselves every three years. One group in addition will receive a radiographer-delivered booklet containing educational messages designed to increase women's knowledge and confidence to detect breast changes and to motivate them to present promptly if they discover a breast change. The third group will receive a 10-minute radiographer-delivered interview in addition to the booklet. The interview is based on the key messages of the booklet and provides the opportunity for the radiographer to reinforce and clarify the content of the booklet.

The intervention is given just once, duration 10 - 15 minutes for the interview group, 5 minutes or less for booklet-alone and optimised usual care. Follow up consists of a questionnaire sent at 1 month and another at 6 months post-intervention for all groups.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Breast awareness, measured one month post-intervention, based on a composite measure of knowledge of non-lump breast cancer symptoms, knowledge of age-related relative risk and confidence to detect a breast change: each component (knowledge/risk/confidence) is given equal weighting and contributes one point to the total score (range 0 to 3), as follows:
1. Non-lump knowledge:
1.1. Score 1 if 5 - 9 symptoms identified
1.2. Score 0 if 0 - 4 symptoms identified
2. Relative risk:
2.1. Score 1 if identify old age group as most at risk
2.2. Score 0 if do not identify old age group as most at risk
3. Confidence:
3.1. Score 1 if check breasts at least once a week/month
3.2. Score 0 if check breasts at least once every six months or less

Secondary outcome measures

Secondary measures are changes at one month and six months post intervention in:
1. Knowledge of breast cancer symptoms (score 0 - 11)
2. Knowledge of relative risk (in the next year who is most likely to get breast cancer? [response categories: a 30 year old woman/a 50 year old woman/a 70 year old woman/a woman of any age])
3. Knowledge of absolute risk (how many women will develop breast cancer in their lifetime? [response categories: 1 in 3/1 in 9/1 in 100/1 in 1000])
4. Confidence to detect a breast change (how often do you check your breasts? [response categories: at least once a week/at least once a month/at least every six months/rarely or never])
5. Breast awareness, measured six months post intervention, based on a composite measure of knowledge of non-lump breast cancer symptoms, knowledge of age-related relative risk, and confidence to detect a breast change

Overall trial start date

30/07/2007

Overall trial end date

30/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Women aged 67 - 70 years attending National Health Service (NHS) breast screening clinics for final routine mammography.

Participant type

Patient

Age group

Senior

Gender

Female

Target number of participants

714

Participant exclusion criteria

1. Any significant disease or disorder that affects ability to consent or participate
2. Insufficient understanding of the English language, or language difficulties
3. Participant going overseas during the six-month study period

Recruitment start date

30/07/2007

Recruitment end date

30/10/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Guy's Campus
London
SE1 3QD
United Kingdom

Sponsor information

Organisation

Institute of Psychiatry (UK)

Sponsor details

Kings College London
De Crespigny Park
London
SE5 8AF
United Kingdom
+44 (0)20 7848 0675
gill.lambert@iop.kcl.ac.uk

Sponsor type

University/education

Website

http://www.iop.kcl.ac.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK (CRUK) (UK)

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

1. 2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19956161
2. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21654683

Publication citations

  1. Results

    Linsell L, Forbes LJ, Kapari M, Burgess C, Omar L, Tucker L, Ramirez AJ, A randomised controlled trial of an intervention to promote early presentation of breast cancer in older women: effect on breast cancer awareness., Br. J. Cancer, 2009, 101 Suppl 2, S40-8, doi: 10.1038/sj.bjc.6605389.

  2. Results

    Forbes LJ, Linsell L, Atkins L, Burgess C, Tucker L, Omar L, Ramirez AJ, A promoting early presentation intervention increases breast cancer awareness in older women after 2 years: a randomised controlled trial., Br. J. Cancer, 2011, 105, 1, 18-21, doi: 10.1038/bjc.2011.205.

Additional files

Editorial Notes