At the American Society of Clinical Oncology (ASCO) Annual Meeting (May 29-31, 2020), researchers from ERT—a global data and technology company that helps minimize risk in clinical trials—shed light on the effectiveness and feasibility of the collection of electronic patient-reported outcomes (ePRO) at home for monitoring quality of life (QoL) in patients with prostate cancer participating in clinical trials.
PROs and ePROs are often used in the development and approval of cancer therapies. Regulatory agencies are increasingly weighing PRO-based endpoints that are indicative of clinical benefit in regard to patient symptoms and overall QoL. While ePRO data in oncology trials have traditionally been collected at clinic visits due to concerns of poor compliance at home, it may be necessary to collect ePRO data more frequently in-between clinic visits because symptoms and QoL can vary significantly throughout a treatment course.
Sarah Tressel Gary, PhD, ERT (Boston, MA), and colleagues analyzed ePRO compliance data from two prostate cancer clinical studies to determine the effects of home completion, length of time in a study, and number of assessments on compliance. A total of 1040 patients in the studies completed ePRO assessments in clinic as well as subsequent assessments completed at home – including a daily diary and up to four questionnaires completed every 4 to 8 weeks for up to 14 months.
Researchers calculated compliance by dividing the number of assessment received by the number of assessments expected in a given assessment period. Each assessment period was categorized as requiring a lower number (daily diary and one questionnaire) or high number (daily diary and two-to-4 questionnaires) of assessments in an effort to evaluate assessment burden.
Overall compliance at the single clinic visit was 100%, researcher reported, and overall compliance at home over 14 months was 80%. Compliance ranged from 78% to 89% over the duration of the studies. Time in the study had no effect on compliance, they added.
Furthermore, researchers found that compliance remained high even as patient numbers declined, and compliance when patients were required to complete a lower number of assessments (80%) was comparable to compliance when patients were required to complete a higher number of assessments (79%).
“The collection of ePRO at home provided high compliance that did not vary with length of time in the study or due to assessment burden,” authors of the study concluded. “At home ePRO assessments provide an effective and feasible approach for recording symptoms and QoL in prostate cancer patients.”—Zachary Bessette
