Nephron Sparing Treatment (NEST) for small renal masses: understanding patients’ and clinicians’ experiences of a cohort-embedded randomised control trial

BACKGROUND: To understand the perspectives and experiences of patients and healthcare professionals regarding the trial design, recruitment and randomisation process to a novel cohort-embedded RCT design for Nephron Sparing Treatment (NEST) for small renal masses. METHODS: Participants were adult patients with a small renal mass (< 4 cm) randomised to receive either percutaneous cryotherapy (CRO) or robot-assisted partial nephrectomy (PRN), and clinicians involved in a trial comparing the two treatments. Semi-structured interviews followed a phenomenological approach and were transcribed verbatim and analysed using thematic analysis. RESULTS: Interviews were conducted with 37 patients and 10 clinicians. Wanting to 'give back' influenced participants' decisions to take part in the trial. Most patients expressed that they had a positive and informed experience of the trial. Patients who accepted randomisation to cryotherapy (experimental intervention) were influenced by information provided regarding a potentially shorter recovery timeframe, length of hospitalisation, and lower risk of complication. Those who were randomised to receive partial nephrectomy (standard of care intervention) stated that they felt less anxious receiving 'non-experimental' treatment and felt safer in the knowledge that the tumour was removed. Clinicians expressed that the trial presented an opportunity to work collegially in identifying the best treatment for patients presenting with SRMs, though highlighted that limited consultation time was a challenge to recruitment. CONCLUSIONS: Findings support the potential feasibility of a future multicentre trial comparing percutaneous cryoablation to robot-assisted partial nephrectomy in the treatment of small renal masses. The study's design, process and intervention were accepted by most, though not all, participants. TRIAL REGISTRATION: ISRCTN18156881.