Trial recruitment challenges – lessons from the ROCS study of radiotherapy after stent insertion in incurable oesophageal cancer
Session type: E-poster/poster
Patients with incurable oesophageal cancer often request additional treatments to control the disease after dysphagia treatment with stent insertion. The benefit of additional treatments such as palliative radiotherapy had limited evidence. The NIHR funded, ROCS trial examined the benefit of palliative radiotherapy in patients with incurable oesophageal cancer treated by stent compared to stent alone. Recruitment and data capture in this setting is very challenging. Here we describe the difficulties and how these were addressed.
ROCS design enabled all follow up data capture at home. An embedded qualitative study with patient (and carer) interviews explored participants’ experiences of recruitment and participation. Regular investigator/research nurse meetings reported findings from the qualitative study and sharing local best practice.
The qualitative study conducted 30 longitudinal interviews with 15 participants (9 radiotherapy, 6 usual care arm) over the first 8 weeks of their trial involvement. Thematic analysis revealed that patients who are severely ill struggle to understand their situation and treatment options making research in this group particularly challenging. Real-time qualitative study findings were disseminated at investigator meetings and prompted changes to timing of randomization, information giving and approaches to presenting trial equipoise, with direct impact on recruitment. Investigator meetings also facilitated changes to local screening processes, shared best practice on how patients were approached and received trial support and improved mechanisms of data capture. Recognition of the rapidly changing clinical status of patients prompted introduction of ‘between visit’ telephone capture of the primary outcome. Home data capture ensured complete primary outcome data for 75% of the modified ITT population (n=199) despite clinical deterioration and median survival of 19 weeks.
Recruitment, attrition and missing data are significant challenges to successful trial completion in palliative cancer populations. Pre-planned follow-up at home, real-time reporting of participant experiences, and regular investigator meetings to interrogate processes and emerging qualitative findings are practical ‘within trial’ solutions to improve information giving and communication of trial equipoise, improve recruitment and randomization over time and minimize extent of missing data.
Embedded qualitative research, home data capture and regular multi-site investigator meetings provide practical “within trial” solutions to improve patient experience in trials.