Plain English Summary
Background and study aims
Cancers that start in a woman's reproductive system are called gynaecological cancers. In the UK gynaecological cancers have a combined incidence in women second only to breast cancer. 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 go to their GP has been developed. It aims to increase awareness and reduce the barriers to seeking help, with the goal of reducing the delay in presentation for gynaecological cancers. The aim of this study is to measure the impact of sending this leaflet to women through their GP, on consultation rates, use of diagnostic tests and referral rates.
Who can participate?
Women aged 40 and over from five GP practices
What does the study involve?
Participants are randomly allocated to either receive the leaflet or to not receive the leaflet. After the leaflet is sent out, changes in attendance rates, relevant tests ordered and referrals made are monitored in the following 6 months and compared to a similar period in the previous year. The data is collected in anonymised form from the practice databases.
What are the possible benefits and risks of participating?
The leaflet increases awareness of gynaecological cancer in women who had read it and may therefore benefit those who receive it as they may have an earlier diagnosis of these cancers with an increased chance of survival. The topic of cancer can be a sensitive one and receiving the leaflet may cause some anxiety in some women. However, the purpose of the leaflet is to encourage women to report their symptoms so it is hoped that if they are concerned by anything they read, they are encouraged to go to their GP for help. The leaflet also contains the contact details of Cancer Research UK’s helpline which can be accessed if women feel uncomfortable going to their GP.
Where is the study run from?
1. Albany House Medical Centre (UK)
2. Danetre Medical Practice (UK)
3. Weedon Medical Centre (UK)
4. Leicester Terrace Health Care Centre (UK)
5. Rothwell Health Care Centre (UK)
When is the study starting and how long is it expected to run for?
February 2013 to October 2014
Who is funding the study?
Cancer Research UK
Who is the main contact?
Prof. Jackie Campbell
jackie.campbell@northampton.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Jackie Campbell
ORCID ID
http://orcid.org/0000-0002-1456-7994
Contact details
University of Northampton
Boughton Green Road
Northampton
NN2 7AL
United Kingdom
+44 (0)1604 892010
jackie.campbell@northampton.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Gynae Cancer Awareness VNo. 4 DATE 1/11/13
Study information
Scientific title
Evaluating the impact of a leaflet to raise awareness in women of symptoms of gynaecological cancers in primary care: a record-based randomised control trial
Acronym
Study hypothesis
Is the proportion of women who consult their GP for symptoms indicative of gynaecological cancer the same whether or not they have received an educational leaflet?
Ethics approval
HRA NRES Committee East Midlands - Nottingham 1, 16/12/2013, REC ref: 13/EM/0432, IRAS project ID: 142767
Study design
Multicentre record-based cross-sectional randomised control trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Other
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Gynaecological cancers
Intervention
Intervention: Educational leaflet on the symptoms of gynaecological cancer sent by post from their GP practice.
Control: No leaflet sent.
Eligible women were identified from GP electronic records and randomised into equal intervention and control groups using SystmOne which also printed address labels for the leaflet mail-out to the experimental group and flagged membership of the study and group membership on the electronic record for subsequent data extraction. The data was extracted for the 4-month time period starting on the day after the GP practice mail out date (for both experimental and control groups).
Intervention type
Other
Phase
Drug names
Primary outcome measure
The proportion of eligible women who consult their GP for symptoms indicative of
gynaecological cancers. This was measured by the presence, and dates, of one or more Read codes in the women's electronic patient record that related to the symptoms described in the educational leaflet and which were indicative of gynaecological cancers. The data was extracted for the 4-month time period starting on the day after the GP practice mail out date (for both experimental and control groups)
Secondary outcome measures
The proportions of eligible women whose GP practice electronic record contained evidence of referrals, diagnostic tests and diagnoses assosiated with gynaecological cancers. These was measured by the presence, and dates, of one or more Read codes in the women's electronic patient record that related to referrals, diagnostic tests and diagnoses associated with gynaecological cancers. The data was extracted for the 4-month time period starting on the day after the GP practice mail out date (for both experimental and control groups)
Overall trial start date
18/02/2013
Overall trial end date
31/10/2014
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women registered with one of the study GP practices
2. Aged 40 years or over
Participant type
Patient
Age group
Mixed
Gender
Female
Target number of participants
16,054
Participant exclusion criteria
1. Women on the oncology and palliative care registers
2. Learning difficulties
3. Mental health problems
Recruitment start date
03/06/2014
Recruitment end date
16/06/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Albany House Medical Centre
NN29 7QH
United Kingdom
Trial participating centre
Danetre Medical Practice
NN11 4DY
United Kingdom
Trial participating centre
Weedon Medical Centre
NN7 4RX
United Kingdom
Trial participating centre
Leicester Terrace Health Care Centre
NN2 6AL
United Kingdom
Trial participating centre
Rothwell Health Care Centre
NN14 6JQ
United Kingdom
Funders
Funder type
Charity
Funder name
Cancer Research 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
The protocol, including the analysis plan, will be deposited in the data repository. The manuscript is currently under preparation for submission to a high impact peer-reviewed journal and is expected to be published by the end of 2017.
IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in the open access Zenodo repository (doi: 10.5281/zenodo.846744) as a .csv file and will include the protocol and metadata details. The data will contain no personal identifiable information and the GP practices from which the data was sourced will be anonymised. Individual consent from participants was not required as confirmed by the HRA REC approval.
Intention to publish date
31/12/2017
Participant level data
Stored in repository
Basic results (scientific)
Publication list
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/30092768