Pilot study: impact of gynaecological cancers leaflet in GP practices
| ISRCTN | ISRCTN25895079 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25895079 |
| Protocol serial number | 12750 |
| Sponsor | City University London (UK) |
| Funder | Cancer Research UK (UK) |
- 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
Scientific
City Community and Health Sciences
10 Northampton Square
London
EC1V 0HB
United Kingdom
| Mandeep.Sekhon.2@city.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Non-randomised interventional and observational; Design type: Diagnosis |
| Secondary study design | Non randomised study |
| Study type | 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(s) |
Rates of relevant consultations. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
City Community and Health Sciences
London
EC1V 0HB
United Kingdom
EC1V 0HB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
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.
