LESSONS LEARNT FROM A QUALITATIVE STUDY FOR BEST PRACTICE ECOA IMPLEMENTATION IN ONCOLOGY CLINICAL TRIALS
Author(s)
Mowlem F1, Sanderson B1, Platko J2, Byrom B3
1Signant Health, London, UK, 2Signant Health, Plymouth Meeting, PA, USA, 3Signant Health, Nottingham, NTT, UK
Presentation Documents
OBJECTIVES: To understand the impact of the disease and its treatment on the ability of oncology patients to use eCOA solutions. METHODS: Seven participants who had experienced a cancer diagnosis and treatment participated in semi-structured qualitative interviews to explore the impact of symptoms associated with treatment on device use for recording eCOA. RESULTS: Themes that emerged as impacting eCOA use were: peripheral neuropathy of the hands, tiredness and fatigue, difficulties maintaining focus and concentration, and the time-point in the treatment cycle. 57% of participants reported experiencing peripheral neuropathy of the hands that would impact their device use, 86% reported fatigue and/or concentration and memory issues, with 71% detailing that the time-point in their treatment regimen would influence their symptoms and ability to interact with an eCOA solution. No issues with reading ability were reported and participants had a positive attitude towards to use of technology to complete assessments. eCOA was preferred to paper completion and mobile devices reported as a helpful tool to say connected when confined to the home. Suggested approaches to improve usability were: larger, well-spaced buttons to deal with finger numbness, the ability to pause a survey mid-way and complete at a later point, and presenting all question text and response options together to reduce reliance on remembering the question recall period. Caregiver completion tended not to be a popular solution. CONCLUSIONS: eCOA offers considerable opportunity to measure treatment effects in oncology patients but symptoms associated with the disease and treatment can impact their use of technologies for completing PROMs. The knowledge gained in this research can be harnessed to ensure electronic solutions are optimal and ‘fit for purpose’, and the lessons learnt used to inform best practice recommendations for implementation of eCOA in this population, placing patient needs at the forefront.
Conference/Value in Health Info
2020-05, ISPOR 2020, Orlando, FL, USA
Value in Health, Volume 23, Issue 5, S1 (May 2020)
Code
PCN318
Topic
Clinical Outcomes, Methodological & Statistical Research, Patient-Centered Research
Topic Subcategory
Clinical Outcomes Assessment, Patient-reported Outcomes & Quality of Life Outcomes, PRO & Related Methods, Stated Preference & Patient Satisfaction
Disease
Oncology