Recruitment aids for a phase II randomised trial in low risk bladder cancer


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Rebecca Lewis1,Lauren Maynard1,James Catto2,Joanne Cresswell3,Andrew Feber4,T. R. Leyshon Griffiths5,John Kelly4,Allen Knight6,Maggie Knowles7,John McGrath8,Steven Penegar1,Emma Hall1,Hugh Mostafid9,O n behalf of the CALIBER Trial Management Group6
1The Institute of Cancer Research,2University of Sheffield,3South Tees Hospitals NHS Foundation Trust,4University College London,5University of Leicester,6-,7St James's University Hospital,8Royal Devon & Exeter NHS Foundation Trust,9Royal Surrey County Hospital

Abstract

Background

Non-muscle invasive bladder cancer (NMIBC) is a locally recurring disease for which patients undergo long term cystoscopic surveillance. CALIBER is a multicentre phase II feasibility study comparing intravesical chemotherapy (chemoresection) with surgery (standard of care) in patients with recurrent low risk NMIBC (2:1 chemoresection:surgery randomisation). The primary aim is to assess complete response to chemoresection and the trial is randomised to test feasibility of recruitment to a larger randomised phase III trial.

We anticipated that patient recruitment would be challenging due to complex tumour inclusion criteria (risk stratification using EORTC tables), multiple treatment pathways and disparate treatment strategies. As such we developed recruitment aids and surveyed investigators about their use.

Method

Short patient information leaflets and posters for patients and clinicians were provided to highlight the trial to those attending/conducting surveillance cystoscopies. A CALIBER specific risk calculation tool was provided as an aid to assess eligibility. We surveyed 31 centres about the use of these aids.

Results

Responses were received from 19/31 centres. 17/19 (89%) are using at least one of the short patient information leaflet, patient, or clinician poster; 4/19 (21%) responders are using all three and 2/19 are using none. Based on this small sample, recruitment appears higher in centres using at least one recruitment aid (average recruitment per centre month of 0.18 vs 0.04).

Since distributing the CALIBER risk calculator, the number of eligibility queries received by the coordinating clinical trials unit has decreased. Initial feedback from centres suggests it is a useful tool for local pre-screening.

Conclusion

With provision of targeted recruitment aids, centre staff training and ongoing support from the coordinating clinical trials unit, potential barriers to recruitment in a trial with challenging patient identification pathways and complex eligibility criteria can be managed effectively.