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.
Ethics approval
12/EE/0231
Study design
Non-randomised interventional and observational; Design type: Diagnosis
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
GP practices
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
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
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