Title: Tailoring clinical trials to increase patient engagement: Impact on patient-reported outcomes in oncology
Date: Thursday, August 10th, 2023
Time: 5:30 p.m. – 7:30 p.m. PT
Location: Ballroom A
Background: As regulators put more attention on patient-reported outcomes (PROs) in oncology clinical trials, it is vital to understand patient preferences and motivation for completing PROs. We investigated preferences and motivations for symptom reporting and how this may differ between participants with cancer and with other chronic non-oncology diseases.
Methods: Participants completed an online survey focusing on preferences for using devices to report symptoms and what motivates them to complete PROs. Statistical analyses included a descriptive analysis of responses and Chi-Squared tests to examine differences between subgroups (oncology vs. participants with arthritis, diabetes, and chronic obstructive pulmonary disease).
Results: Participants with cancer (N = 16) preferred using their own smartphone (31%) over going to a website (19%) or using a study-dedicated device (6%) to report symptoms, with 44% being happy with any option (44%). 88% of participants reported that receiving regular information to help manage their symptoms would motivate them the most to complete their PROs on a regular basis. Receiving a small financial compensation (81%) and knowing that their data was being reviewed by a healthcare professional (75%) were also strong motivators to complete PROs. The least preferred motivator was compensation in the form of charity donations (25%). Preference for reporting symptoms differed between subgroups (p=0.04), such that participants with cancer showed a higher preference for using their own smartphone compared to the non-oncology subgroup (N=30). The non-oncology subgroup was more likely to report notifications and alarms (p=0.04) as strategies that would encourage them to complete PROs.
Conclusion: This exploratory analysis suggests the importance of considering a range of symptom reporting strategies and the potential for tailoring strategies to fit patient preferences. The preference to use personal smartphones to report symptoms in participants with cancer suggests that a Bring-Your-Own-Device (BYOD) strategy may be particularly suited for oncology clinical trials.
Director, eCOA Science and Consulting at Clario
Dr. Dumais is a scientist with over 13 years of experience in behavioral and life science research. She has expertise in the implementation of electronic clinical outcome assessments (eCOA) and the development and validation of patient reported outcomes (PROs) to support labeling claims. She is currently the Director of eCOA Science and Consulting at Clario, a global data and technology company that helps to minimize risk in clinical trials. She consults on best practices for questionnaire design and eCOA design/use to drive data integrity and patient engagement and develops custom site rater training and participant training for improving accuracy in COA reporting and improving inter-and intra-rater reliability.