Condition category
Cancer
Date applied
20/12/2013
Date assigned
20/12/2013
Last edited
20/03/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Mandeep Sekhon

ORCID ID

Contact details

City Community and Health Sciences
10 Northampton Square
London
EC1V 0HB
United Kingdom
Mandeep.Sekhon.2@city.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

12750

Study information

Scientific title

Evaluating the impact of a leaflet to raise awareness in women of symptoms of gynaecological cancers on consultation rates, use of diagnostic tests and referrals in primary care. A pilot study in GP practices

Acronym

Study hypothesis

Gynaecological cancers have a combined incidence in women second only to breast cancer in the UK. Evidence shows that earlier diagnosis could reduce the survival gap between England and the European average. An information leaflet detailing the symptoms of gynaecological cancers and encouraging women to present to their GP has been developed. It aims to increase awareness and reduce help-seeking barriers, with the goal of reducing delay in presentation for gynaecological cancers. This study, funded by the National Awareness and Early Diagnosis Initiative, evaluates the impact of sending this leaflet to women through their GP, on consultation rates, use of diagnostic tests and referral rates. The results will inform a future larger RCT, testing the impact of the leaflet more widely.

Women aged 40 years and over will be identified from the lists of nine GP practices (N~16250) and mailed the leaflet with a cover letter from their GP. Patients on the palliative care, mental health or oncology registers will be excluded. After the leaflet is sent out, we will monitor any changes in attendance rates, relevant investigations ordered and referrals made in the six months following, and compare this to a similar period in the previous year. Women will not be approached during this study, but rather the outcome data will be collected and collated in anonymised form from the practice databases.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=12750

Ethics approval

12/EE/0231

Study design

Non-randomised interventional and observational; Design type: Diagnosis

Primary study design

Interventional

Secondary study design

Non randomised controlled trial

Trial setting

GP practices

Trial type

Screening

Patient information sheet

Condition

Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases

Intervention

6250 women sent the leaflet of whom a proportion (possibly up to 30%) will visit their GP with gynaecological symptoms in the six months following receiving the leaflet.

Educational intervention, Leaflet about gynaecological cancers.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Rates of relevant consultations.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

25/06/2012

Overall trial end date

30/04/2013

Reason abandoned

Eligibility

Participant inclusion criteria

All women 40 years and over in nine GP practices across north west London

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

Planned Sample Size: 16520; UK Sample Size: 16520

Participant exclusion criteria

Women on the palliative care, mental health or oncology registers at these practices

Recruitment start date

25/06/2012

Recruitment end date

30/04/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

City Community and Health Sciences
London
EC1V 0HB
United Kingdom

Sponsor information

Organisation

City University London (UK)

Sponsor details

City Community and Health Sciences
10 Northampton Square
London
EC1V 0HB
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

Cancer Research UK (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

Publication citations

Additional files

Editorial Notes