AIMS: De-escalation trials are challenging and sometimes may fail due to poor recruitment. The OPTIMA Prelim randomised controlled trial (ISRCTN42400492) randomised patients with early stage breast cancer to chemotherapy versus 'test-directed' chemotherapy, with a possible outcome of no chemotherapy, which could confer less treatment relative to routine practice. Despite encountering challenges, OPTIMA Prelim reached its recruitment target ahead of schedule. This study reports the root causes of recruitment challenges and the strategies used to successfully overcome them.
MATERIALS AND METHODS: A mixed-methods recruitment intervention (QuinteT Recruitment Intervention) was used to investigate the recruitment difficulties and feedback findings to inform interventions and optimise ongoing recruitment. Quantitative site-level recruitment data, audio-recorded recruitment appointments (n = 46), qualitative interviews (n = 22) with trialists/recruiting staff (oncologists/nurses) and patient-facing documentation were analysed using descriptive, thematic and conversation analyses. Findings were triangulated to inform a 'plan of action' to optimise recruitment.
RESULTS: Despite best intentions, oncologists' routine practices complicated recruitment. Discomfort about deviating from the usual practice of recommending chemotherapy according to tumour clinicopathological features meant that not all eligible patients were approached. Audio-recorded recruitment appointments revealed how routine practices undermined recruitment. A tendency to justify chemotherapy provision before presenting the randomised controlled trial and subtly indicating that chemotherapy would be more/less beneficial undermined equipoise and made it difficult for patients to engage with OPTIMA Prelim. To tackle these challenges, individual and group recruiter feedback focussed on communication issues and vignettes of eligible patients were discussed to address discomforts around approaching patients. 'Tips' documents concerning structuring discussions and conveying equipoise were disseminated across sites, together with revisions to the Patient Information Sheet.
CONCLUSIONS: This is the first study illuminating the tension between oncologists' routine practices and recruitment to de-escalation trials. Although time and resources are required, these challenges can be addressed through specific feedback and training as the trial is underway.
Bibliographical noteFunding Information:
The authors would like to acknowledge the contributions of all the patients who participated in the OPTIMA Prelim trial. The views and opinions expressed herein are those of the authors. The authors had full access to the data and are responsible for the content of this manuscript. The OPTIMA Prelim trial was funded by the National Institute of Health Research Health Technology Assessment programme (award 10/34/01), United Kingdom. The funder had no role in the study design; data collection, analysis or interpretation; the decision to publish or preparation of the manuscript. R.C. Stein was supported by the National Institute for Health Research University College London Hospitals Biomedical Research Centre, United Kingdom .
© 2020 The Royal College of Radiologists
Copyright 2020 Elsevier B.V., All rights reserved.
- Breast cancer
- de-escalation trial
- qualitative research
- randomised controlled trials
ASJC Scopus subject areas
- Radiology Nuclear Medicine and imaging