Recruiting patients with advanced malignant and non-malignant disease: lessons learned from a palliative care RCT

Abstract

Aims: Recruiting patients to palliative randomised controlled trials (RCTs) is challenging. We will describe differing recruitment trajectories for patients with advanced cancer and non-cancer disease to a palliative RCT, activities undertaken to achieve targets and their impacts, and lessons learned to inform future RCTs. Methods: Analysis of descriptive recruitment statistics (patient identification, response and completion rates) to Phase II pilot (COPD only) and Phase III pragmatic singleblind fast track RCT of a breathlessness intervention service for advanced disease; Phase III included sub-protocols for cancer and non-cancer diseases. Documentary analysis of: Recruitment Activity Log, Trial Management and Advisory Group minutes and fieldnotes. Results: Recruitment targets for patients with non-cancer disease were achieved. The route to recruitment was service- referral thus referral rates impacted on recruitment alongside response rates. Cancer patient recruitment was far slower despite concerted efforts to increase referrals by raising the service profile. Cancer referrals only improved when researchers attended clinics, supporting clinical staff in patient identification: recruitment more than tripled from 0.8 to 3.0 patients/month. Three possible reasons for this: (1) dedicated time, (2) reciprocity and (3) established relationships. Predictably, response rates remained lower for patients with cancer than for those with non-cancer disease. Conclusions: Recruitment was partly referral-driven, thus gate-keeping did not explain differences. Clinical interprofessional relationships consolidated in Phases 0-II drove early non-cancer referrals. Local palliative care services pre-existed for patients with cancer. Consideration of the natural history and context of a service is thus important in predicting recruitment. Pilot trials should include qualitative elements and all disease groups. Placing researchers in relevant clinical settings is helpful.