Does receiving a leaflet about the symptoms of gynaecological cancers affect women's attendance at their GP practice?
| ISRCTN | ISRCTN61738692 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61738692 |
| Secondary identifying numbers | Gynae Cancer Awareness VNo. 4 DATE 1/11/13 |
- Submission date
- 17/08/2017
- Registration date
- 23/08/2017
- Last edited
- 13/08/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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
Contact information
Scientific
University of Northampton
Boughton Green Road
Northampton
NN2 7AL
United Kingdom
 ORCID ID |
0000-0002-1456-7994 |
|---|---|
| Phone | +44 (0)1604 892010 |
| jackie.campbell@northampton.ac.uk |
Study information
| Study design | Multicentre record-based cross-sectional randomised control trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| 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 |
| Study objectives | 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(s) | HRA NRES Committee East Midlands - Nottingham 1, 16/12/2013, REC ref: 13/EM/0432, IRAS project ID: 142767 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 18/02/2013 |
| Completion date | 31/10/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Sex | Female |
| Target number of participants | 16,054 |
| Key inclusion criteria | 1. Women registered with one of the study GP practices 2. Aged 40 years or over |
| Key exclusion criteria | 1. Women on the oncology and palliative care registers 2. Learning difficulties 3. Mental health problems |
| Date of first enrolment | 03/06/2014 |
| Date of final enrolment | 16/06/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
United Kingdom
United Kingdom
United Kingdom
United Kingdom
United Kingdom
Sponsor information
University/education
Boughton Green Road
Northampton
NN2 7AL
England
United Kingdom
"ROR" |
https://ror.org/04jp2hx10 |
|---|
Funders
Funder type
Charity
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 | 31/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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 plan | 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. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 09/08/2018 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/08/2018: Publication reference added.
