1. ¹School of Nursing, University of Nottingham, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham NG7 2UH, UK
2. ²Trent Institute for Health Services Research, University of Nottingham, Faculty of Medicine and Health Sciences, University of Nottingham, Nottingham NG7 2UH, UK

Correspondence: Professor K Cox, E-mail: Karen.cox@Nottingham.ac.uk

Received 18 February 2005; Revised 11 April 2005; Accepted 24 April 2005; Published online 28 June 2005.

Abstract

The effect of a nurse-managed intervention, for early phase cancer trial participants at trial conclusion, on psychosocial outcomes was evaluated at two cancer centres in the Midlands, England using a randomised controlled trial. It involved 117 patients who were participating in an early phase cancer clinical trial. It was a nurse-managed trial exit, which included a trial exit interview, trial feedback information leaflet and telephone follow-up compared with standard care at trial conclusion. Psychological distress at 1 week and 4–6 weeks post-trial conclusion, patient's knowledge and understanding and patient's satisfaction were assessed. The results showed there was no significant difference between the two groups regarding scores for anxiety and depression at time one and time two. There is some suggestion that the intervention reduced anxiety from trial conclusion to follow-up (P=0.27). Patients in both groups felt they had contributed to cancer research through trial participation. However, intervention patients were more likely to feel that they knew how the trial was going (P<0.001), knew how other people in the trial were doing (P=0.001), had all the feedback they needed about the trial they took part in (P<0.01) and knew how they would be followed up (P=0.02). Patient satisfaction with the intervention was high (median score=4.5 where 5 is greatest satisfaction). In conclusion, nurse-managed trial conclusion led to positive outcomes for patients who had recently completed a clinical trial.