Abstract A32: Process improvement in online consenting for the Moffitt Cancer Center Total Cancer Care biobanking protocol
Authors: Siegel Erin M. , Hawkins Kyle P. , Hildreth Lynne , Grose Timothy , Stringfellow David , Bloomer Amanda , Tworoger Shelley , Rollison Dana , Gilbert Scott , Sellers Thomas A. 
Published: June 2022

Introduction: Broad-based institutional biobanking protocols are crucial for advancing personalized medicine in cancer research. However, in-person consenting is resource intensive and interrupts clinic flow. Ethical standards support online consenting for biobanking protocols, which has the potential to reach more participants for enrollment. Herein, we discuss challenges in implementing broad-based online patient consenting at the Moffitt Cancer Center (MCC) for our institutional biobanking protocol, Total Cancer Care (TCC), and subsequent steps to better integrate this process with clinical care on-boarding. We hypothesized that implementation of online patient consenting would broaden patient enrollment into TCC and the redesigned process would increase the number of online patient consents by at least 5-fold.

Methods: TCC started as the institutional biobanking protocol in 2006. TCC online consent was implemented in Feb. 2013 (Phase 1) and redesigned in Oct. 2018 (Phase 2). Phase 1 was developed with the guidance of ethicists and patient advisors, and consisted of (a) communication via email, (b) education online with text, video, and FAQs, (c) review and initialing of the Informed Consent form (ICF), and (d) typed name signature on ICF. The Phase 2 redesign created a more streamlined process that was integrated into the MCC New Patient To-Do list, a clinical on-boarding platform. The revised version used interactive material, a shorter animated video, and an electronically signed ICF. We compared the number of online patient consents in Phase 1 and 2 and have preliminary data on patient acceptance of Phase 2.

Results: Since 2006, 108,898 MCC patients enrolled into TCC. 342 patients enrolled online in Phase I between 2013–2018 (5/mo). In the initial 6 weeks of Phase 2, there was a 13-fold increase in online consenting (n=98, 65/mo) compared to Phase 1. According to web analytics, TCC pages in Phase 2 were viewed 991 times compared to 432 views over 6 weeks in Phase 1. In general, patient characteristics were similar between those who enrolled online and those who enrolled in person during the same timeframe, with a slightly higher percentage of online vs. in-person enrollees being female (57% vs. 53%, respectively). In a small survey of new patients who viewed the clinical on-boarding platform in Phase 2, 76% reviewed the TCC material without issue whereas 20% did not review the TCC material.

Conclusions: While online consenting has tremendous potential, we had very low uptake of patient education and consenting in our initial design (Phase 1). Challenges included a lack of visibility within the patient portal and a dependency on email as the primary mode of directing patients to online consenting. Alternatively, we have seen initial success with our second phase of online consenting that was directly integrated with patient on-boarding. Initial success highlights the potential of this modality to increase patient enrollment into biobanking studies. Further evaluation of this approach is ongoing.

Citation Format: Erin M. Siegel, Kyle P. Hawkins, Lynne Hildreth, Timothy Grose, David Stringfellow, Amanda Bloomer, Shelley Tworoger, Dana Rollison, Scott Gilbert, Thomas A. Sellers. Process improvement in online consenting for the Moffitt Cancer Center Total Cancer Care biobanking protocol [abstract]. In: Proceedings of the AACR Special Conference on Modernizing Population Sciences in the Digital Age; 2019 Feb 19-22; San Diego, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(9 Suppl):Abstract nr A32.