Enhancing cancer trial management: An intervention study of the impact of providing information, trial results and support to patients in phase I and II anti-cancer drug trials at trial conclusion

This paper presents qualitative findings from a three year study which set out to develop and test a nurse-led strategy for improving the management of the conclusion of patients’ participation in early cancer clinical trials. Most previous research has concentrated on recruitment, obtaining informed consent, and ensuring participation in trials. This study focused on the management of trial conclusion, a neglected area. The strategy (trial exit interviews, written information and telephone follow-up) was evaluated through a randomised controlled trial that assessed its impact on, and effectiveness in improving, the trial conclusion experience. Outcome measures were patient perceptions of trial participation and conclusion, patients’ knowledge and understanding, psychological distress, satisfaction with the intervention and adjustment to no longer being in a trial. Data were collected through questionnaires, standardised psychosocial and patient-satisfaction measures, and in-depth interviews.

The findings reported in this paper relate to the data collected through in-depth interviews. The interview data showed that patients in the intervention group expressed fewer fears of abandonment at the conclusion of the trial, they appreciated being given feedback about the trial in which they had participated, expressed satisfaction with the exit interview, and derived a feeling of support from the follow-up telephone call. These findings support and illuminate other quantitative findings that we have reported elsewhere (Cox et al., 2005) and demonstrate that low cost, simple interventions can be effectively incorporated into practice.