Condition category
Cancer
Date applied
17/08/2017
Date assigned
23/08/2017
Last edited
22/08/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

Trial participating centre

Danetre Medical Practice
NN11 4DY

Trial participating centre

Weedon Medical Centre
NN7 4RX

Trial participating centre

Leicester Terrace Health Care Centre
NN2 6AL

Trial participating centre

Rothwell Health Care Centre
NN14 6JQ

Sponsor information

Organisation

University of Northampton

Sponsor details

Boughton Green Road
Northampton
NN2 7AL
United Kingdom

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes