BACKGROUND: Information leaflets have been shown to significantly improve awareness of the symptoms of gynaecological cancers and to reduce perceived barriers to seeking medical help. This record-based, parallel, randomised control trial study aimed to assess whether receipt of a leaflet would change the behaviour of women experiencing symptoms indicative of gynaecological cancers by prompting them to visit their general practitioner (GP).
METHODS: 15,538 women aged 40 years or over registered with five general practices in Northamptonshire, UK were randomised to two groups using the SystmOne randomise facility. Those in the intervention group received an educational leaflet from their general practice explaining the symptoms of gynaecological cancers and advising symptomatic women to visit their GP. The control group were not contacted. Electronic records were interrogated to extract sociodemographic data and details of GP consultations for symptoms, tests, referrals and diagnoses relating to gynaecological cancers in the 4-month period following the mail-out of the leaflets.
RESULTS: 7739 records were extracted from the intervention group and 7799 from the control group. 231 (3.0%) of the women in the intervention group, and 207 (2.7%) of the controls, presented to their GP with a relevant symptom during the 4-month period following leaflet distribution. The slightly higher rate in the intervention group did not reach statistical significance at the 5% level (RR = 1.11; 95% CI 0.92-1.33; z = 1.08; p = 0.28). There was a significantly lower mean time to first presentation in the symptomatic intervention group (57.2 days, sd = 36.5) compared to the control group (65.2 days, sd = 35.0) (t = - 2.415; p = 0.016). Survival analysis did not reveal a difference between the patterns of presentation in the two cohorts (Log Rank (Mantel-Cox) χ 2 = 1.42; p = 0.23).
CONCLUSION: There was no difference between intervention and control groups in the proportion of women presenting with symptoms identified in the leaflet in the four months following leaflet distribution, although the women who had been sent a leaflet presented earlier than those in the control group. A larger study is needed to test for a modest effect of leaflet distribution.
TRIAL REGISTRATION: Listed on the ISRCTN registry with study ID ISRCTN61738692 on 23-8-2017 (retrospectively registered).
- Public health
- General practice
- Patient education