Why Oncology Patients Struggle With ePRO and How to Fix It
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Electronic patient-reported outcome solutions offer significant advantages over paper in oncology trials, but the disease and its treatment create specific usability challenges that standard ePRO implementation does not always account for.
This peer-reviewed preliminary communication, published in the Journal of Comparative Effectiveness Research (2020) by Florence Mowlem, Brad Sanderson, Jill Platko, and Bill Byrom of Signant Health, presents findings from qualitative interviews with seven oncology participants and translates them into ten specific implementation recommendations for sponsors designing ePRO solutions in this therapeutic area.
Key Points
- Four of seven participants reported chemotherapy-induced peripheral neuropathy of the hands that would affect their interaction with ePRO devices, describing numbness, stiffness, pins and needles, yet all still preferred electronic completion over paper, with one participant describing it as "110% easier."
- Six of seven participants reported fatigue and concentration impairments that would affect their ability to complete PRO instruments, with some reporting they could only manage a few questions at a time, though none reported readability issues with information presented on the devices themselves.
- Five of seven participants reported that their position in the treatment cycle significantly affected their capacity to complete ePROs, with the early days of a cycle identified as the period of greatest difficulty, consistent with published literature on peak fatigue timing post-chemotherapy.
- Up to 90% of oncology patients experience chemotherapy-induced peripheral neuropathy at some stage during or after treatment, and up to 75% experience cognitive impairments during treatment, making oncology-specific ePRO design adaptations a population-level requirement rather than an edge case.
- Despite reporting all of these challenges, participants were consistently positive about ePRO over paper, with none reporting that their symptoms would deter them from participating in clinical trials or from completing electronic assessments.
- The paper, published in the Journal of Comparative Effectiveness Research (doi: 10.2217/cer-2020-0143), contains the complete participant quotations, thematic analysis, and the full ten-recommendation implementation table that this page summarizes.
That missing data problem has a design solution. When an oncology participant cannot complete a PRO assessment within a short, fixed time window during the worst days of their treatment cycle, the data is simply absent. When a participant with hand numbness cannot reliably operate a sliding scale, the data recorded may not accurately reflect their experience. Neither of these failures is inevitable. They are the predictable consequence of implementing standard ePRO designs in a population with specific, well-documented physical and cognitive challenges that those designs were not built around.
The FDA's 2009 PRO guidance, reinforced by subsequent oncology-specific guidance, requires sponsors to demonstrate how the timing of PRO collection specified in the protocol has been enforced. Electronic solutions provide the audit trail that paper cannot. But that audit trail only exists if participants can complete the assessments. For sponsors designing oncology ePRO solutions today, the usability decisions made during implementation directly determine whether the PRO data in a regulatory submission is complete enough to support labelling claims.
Three distinct themes emerged with direct implications for ePRO design. Peripheral neuropathy created difficulties with precise touch interactions, particularly on small buttons and sliding scales, though tapping remained possible for most participants even when other fine motor tasks were impaired.
Fatigue and concentration impairment created a need for flexibility in completion timing and the ability to pause and return to incomplete assessments, rather than requiring completion within a single session. Treatment cycle position created predictable periods of very low capacity, particularly in the first days following chemotherapy administration, requiring both flexible time windows and the ability to complete assessments at different times of day based on how participants felt.
The paper translates these findings into ten specific recommendations covering button size and spacing, visual analogue scale interaction options, recall period presentation alongside every question, flexible completion windows, rest intervals between questionnaires, stylus availability, BYOD implementation where appropriate, automated reminders, sensitivity around caregiver-assisted completion, and simple PIN reset and quick reference guide access. For sponsors and CROs designing ePRO implementation for oncology programs, the full paper provides both the qualitative evidence base and the practical implementation checklist.
"Symptoms associated with cancers and anticancer treatments can impact the use of technologies. The recommendations for optimizing the electronic implementation of patient-reported outcome instruments in this population provide the potential to improve data quality in oncology trials and places patient needs at the forefront to ensure fit-for-purpose solutions." - Florence Mowlem, Signant Health; Journal of Comparative Effectiveness Research, 2020 (doi: 10.2217/cer-2020-0143)
What specific ePRO usability challenges do oncology patients face that differ from other therapeutic areas?
Three treatment-related factors were identified in this qualitative study: chemotherapy-induced peripheral neuropathy of the hands, which affects precision touch interactions; fatigue and concentration impairment, which reduce the ability to complete assessments in a single sitting; and treatment cycle position, which creates predictable periods of very low capacity in the first days following chemotherapy. Up to 90% of oncology patients experience peripheral neuropathy, and up to 75% experience cognitive impairment during treatment, making these population-level considerations rather than individual exceptions.
Do oncology patients prefer electronic or paper completion of PRO assessments?
What are the most important ePRO design adaptations for oncology clinical trials?
The study identifies ten implementation recommendations. The most frequently cited were larger, well-spaced buttons to accommodate hand numbness; flexible completion time windows to account for varying daily capacity across the treatment cycle; the ability to pause and return to incomplete assessments; presenting the recall period alongside every question rather than relying on participants remembering it across screens; and automated completion reminders. BYOD implementation was also raised by participants as preferable to provisioned devices, as familiarity with their own device reduced the risk of missing completion windows.
AUTHOR BIO
Name: Florence Mowlem
Title and Credentials: Lead author and corresponding author of this study, conducted while at Signant Health
Bio: Florence Mowlem is the lead author and corresponding author of this study, conducted while at Signant Health, London. Co-authors are Brad Sanderson and Bill Byrom, PhD, Vice President of Product Intelligence and Positioning at Signant Health, and Jill Platko of Signant Health, Blue Bell, PA.
The study was published as a preliminary communication in the Journal of Comparative Effectiveness Research in December 2020 (doi: 10.2217/cer-2020-0143). All authors were employed by Signant Health at the time the research was conducted.
Designing ePRO implementation for an oncology program and working through device, modality, and usability strategy? Speak to a Signant eCOA scientist about oncology-specific ePRO design, BYOD suitability, and implementation best practices for cancer clinical trials.
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