The design and delivery of late phase supportive care oncology trials
This research programme aimed to deliver and evaluate the pilot phases of two late phase, multicentre, supportive care randomised trials for cancer patients: the EASI-SWITCH (Early switch to oral antibiotics in patients with low risk neutropenic sepsis) and CHALLENGE-UK trial (A UK Cohort of the Colon Health and LifeLong Exercise ChaNGE trial). In total 17 months of recruitment across 10 sites was completed in an extended EASI-SWITCH pilot. Six months of recruitment across 4 sites was completed for CHALLENGE-UK pilot. Additional surveys and qualitative research were undertaken to enhance understanding of the pilot phases. The EASI-SWITCH pilot demonstrated recruitment was feasible but challenging (n=42). A national review of neutropenic sepsis practice confirmed there remained equipoise between the trial arms. Eligibility criteria were adjusted to more accurately reflect clinical practice and the target recruitment rate and number of sites adjusted. There was clinical and patient support to widen the trial’s non-inferiority margin, impacting the sample size. Recruitment barriers were identified which persisted, despite strategies being developed to address modifiable barriers and confirmation of ongoing clinical support for the trial. Significant non-modifiable barriers included however, the smaller than anticipated target population and narrow window of opportunity to recruit, as well as ongoing variability in clinicians’ practices and acute oncology services. The CHALLENGE-UK pilot highlighted recruitment was also feasible but challenging (n=13). To trial healthcare professionals the intervention appeared acceptable and trial procedures feasible, particularly once site set up was complete. A national review of practice confirmed physical activity advice or referral to services was not standard practice. Additional recruitment strategies are planned, including multidisciplinary education to improve confidence in addressing patient reported barriers. Both trials have improved understanding of the challenges encountered in delivering supportive care oncology trials. Future trials should consider these barriers, with continued transparent reporting of pilot work encouraged.
Clinical trial, cancer, physical activity, neutropenic sepsis, supportive care
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