Pilot study: impact of gynaecological cancers leaflet in GP practices

ISRCTN	ISRCTN25895079
DOI	https://doi.org/10.1186/ISRCTN25895079
Secondary identifying numbers	12750

Submission date: 20/12/2013
Registration date: 20/12/2013
Last edited: 04/02/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Miss Mandeep Sekhon
Scientific

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

Email	Mandeep.Sekhon.2@city.ac.uk

Study information

Study design	Non-randomised interventional and observational; Design type: Diagnosis
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	GP practice
Study type	Diagnostic
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
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
Study objectives	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.
Ethics approval(s)	12/EE/0231
Health condition(s) or problem(s) studied	Topic: Primary Care Research Network for England; Subtopic: Not Assigned; Disease: All Diseases
Intervention	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, any changes in attendance rates, relevant investigations ordered and referrals made in the six months following will be monitored, and compared 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.
Intervention type	Behavioural
Primary outcome measure	Rates of relevant consultations.
Secondary outcome measures	Not provided at time of registration
Overall study start date	25/06/2012
Completion date	30/04/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	Planned Sample Size: 16520; UK Sample Size: 16520
Key inclusion criteria	All women 40 years and over in nine GP practices across north west London
Key exclusion criteria	Women on the palliative care, mental health or oncology registers at these practices
Date of first enrolment	25/06/2012
Date of final enrolment	30/04/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

City Community and Health Sciences

London
EC1V 0HB
United Kingdom

Sponsor information

City University London (UK)
University/education

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

"ROR"	https://ror.org/04489at23

Funders

Funder type

Charity

Cancer Research UK (UK)
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

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

Editorial Notes

04/02/2020: The principal investigator has confirmed that the results of the study will not be published.
30/01/2020: No publications found, verifying study status with principal investigator.
06/02/2017: No publications found, verifying study status with principal investigator.