Recruitment of participants is critical to the success of randomised controlled trials (RCTs). However, poor accrual to RCTs is a common problem. Recruitment through cancer registries usually involves an approach via the treating clinician. Standardised formats for patient information and consent forms (PICFs), as recommended by many ethics committees, often result in lengthy and uninviting documents.
To implement a recruitment method based on social marketing approaches and direct-to-patient approach by the WA Cancer Registry (WACR) within the Improving Rural Cancer Outcomes Trial.
In collaboration with consumers and Cancer Council WA we developed an inviting and simple patient information brochure about participation in the trial. This was mailed with a letter from the WACR directly to newly diagnosed cancer patients who met our inclusion criteria. After three-weeks, researchers follow-up non-responders via phone or mail to see if they would like to participate.
Our initial target sample size was 850 participants recruited over 24 months by March 2014, requiring a 40% accrual rate. By mid-February 2014, 1,220 people had been recruited to the trial (59% accrual rate). The estimated final sample will be 1,250 representing 47% higher accrual than originally estimated. Participants responded positively to the language and appealing use of colour of both their questionnaire and plain-language information flyer. The design helped prompt recall of the invitation during follow-up.
Our novel recruitment methods resulted in an approximately 50% higher accrual rate than originally planned. This is a very unusual finding given the optimistic biases inherent in most research protocols. The simple and colourful patient information materials and direct-to-patient recruitment from the WACR were crucial to high participation rate. Ethics committees should consider altering their standard, to allow more engaging layout and language that is patient friendly in PICFs and allow cancer registries to approach patients directly.