So we wanted to ask the question of does the quality of life of patients, pediatric oncology patients on an early phase clinical trial, is it different from those who did not have the ability to go on an early phase clinical trial, so those with a relapsed or refractory cancer? And why we wanted to do that was to help inform the future of clinical trial design, but also to provide a valuable tool for the consenting process for not only the clinician, but for the patient and the family...
So we wanted to ask the question of does the quality of life of patients, pediatric oncology patients on an early phase clinical trial, is it different from those who did not have the ability to go on an early phase clinical trial, so those with a relapsed or refractory cancer? And why we wanted to do that was to help inform the future of clinical trial design, but also to provide a valuable tool for the consenting process for not only the clinician, but for the patient and the family. Our primary aim was to determine if patients who were enrolled on that early phase clinical trial actually had an improved quality of life. And that was our hypothesis. So how we went about doing that is that this is a Canadian national study with 11 pediatric oncology sites across Canada enrolling patients. So that’s coast to coast, ocean to ocean. And the eligibility was 2 to 18 years of age. Our Arm A patients were those who were enrolled on an early phase, so a phase one or phase two trial in pediatric oncology. And Arm B was those who didn’t have one that they could go on or who were receiving another type of therapy not on an early phase trial with a relapsed or refractory cancer. We used the PedsQL 3.0 acute cancer module to assess quality of life. We did measures of that at baseline, week four, and week eight after enrollment on our study, and it was done with guardians and with patients who were five years and older. So what we found in our data is that there was not a difference in PedsQL scores between the enrollment groups comparing eight weeks to baseline and after adjusting for the baseline scores. So in other words, patients on an early phase trial had no difference in quality of life scores compared to those who were not enrolled in an early phase trial. Thus, being enrolled on an early phase clinical trial did not alter your quality of life from baseline.
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