Abstract
AimsDe-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 methodsA 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. ResultsDespite 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. ConclusionsThis 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.
Highlights
Multiparameter tumour gene expression assays have driven new approaches to adjuvant chemotherapy decision-making for breast cancer [1e3]
In the recruitment phase, 14 semi-structured interviews were conducted with trial management group (TMG) members and oncologists from six sites and eight research nurses took part in structured interviews
The interviews were conducted with staff from sites considered ‘mid-range’ in terms of recruitment rates
Summary
Multiparameter tumour gene expression assays have driven new approaches to adjuvant chemotherapy decision-making for breast cancer [1e3]. The UK’s National Institute for Health and Care Excellence has approved the use of several multi-parameter assays (MPAs) to guide adjuvant chemotherapy decisions in patients with oestrogen receptor-positive, human epidermal growth factor receptor 2-negative lymph node-negative breast cancer. For more than 50 years, RCTs have been driving important developments in the treatment of breast cancer [5e7], but recruitment issues have threatened the timely and successful completion of trials [8,9]. This is true of de-escalation of treatment studies, which have come to the fore in early breast cancer research in recent years [10]. Research has revealed a number of challenges for recruiters, including the emotional burden of recruitment, lack of equipoise and reconciling the roles of clinician and researcher [12,13]
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