Abstract
Background
Informed consent is essential to ensuring ethical conduct of clinical research in oncology, but can be challenging and time-consuming to implement. Electronic consenting (e-consent) may address these issues, but acceptability of e-consent among patients with cancer must be assessed.
Methods
An asynchronous preliminary e-consent was developed for a prospective circulating tumor DNA testing study for patients with colorectal/pancreatic cancer. Following e-consent, patient satisfaction was assessed in a follow-up call before full consent was obtained. Acceptability was assessed with descriptive statistics and bivariate analysis.
Results
Fifty-one participants completed the preliminary e-consent, 90% of which preferred electronic full consent over traditional consent. Comfort enrolling after e-consent was rated highly by 93% of participants. Additionally, 80% of participants indicated that a follow-up call had no impact on decision to enroll.
Conclusion
These findings suggest that asynchronous e-consenting is highly acceptable among oncology patients but future work should assess comprehension with this approach.
Keywords: bioethics, informed consent, patient satisfaction, medical oncology, digital technology
Introduction
Participation in research is critical to advancing standards of care in oncology. However, the consent process is burdening for patients and clinicians. Modern oncology consent forms are complex and can confuse patients or deter participation altogether, while patient education of study details can be time consuming for clinicians.1,2 Methods to improve the consent process for both patients and clinicians are needed.
Electronic consenting (e-consent) is a potential strategy for improving the consent experience. E-consent refers to the use of multi-media to enhance the informed consent process,3 and has shown to improve patient satisfaction, tailor content delivery to patient values and reduce administrative burden on clinicians.4–6 To date, there has been limited evaluation of e-consenting in oncology, particularly in interventional research where participation may be a deeply personal decision. This feasibility study assesses participant acceptability of an asynchronous e-consent method for a prospective interventional study.
Methods
An e-consent tool was designed to asynchronously deliver study information and obtain consent for the VICTORI study. VICTORI is a non-randomized prospective study investigating serial testing of circulating tumor DNA (ctDNA) for early detection of molecular residual disease in colorectal cancer (CRC) and pancreatic cancer (PC). Details of VICTORI have been previously described.7 Patients eligible for VICTORI were eligible for e-consenting if they had sufficient time to complete e-consent procedures before initiation of their planned treatment.
Eligible patients were screened and contacted by the research team, or patients were introduced to the study directly by their physician during a clinical visit. Prior to any contact by the research team, permission to approach patients about VICTORI was obtained from their treating physician. Patients who expressed interest in e-consenting received an email from the research team with a link to a digital consent form using the REDCap survey function. The form contained a 5-minute video of the principal investigator describing the study with a slideshow of consent details. Text transcription was embedded as a drop-down feature and contact information of the principal investigator and research coordinator were available. Participants could then provide preliminary consent on the survey form, which allowed collection of the first blood sample and additional study contact. Samples were only analyzed if patients provided full study consent. Within 5 days of an e-consent submission, patients were contacted in a follow-up call by a research coordinator to collect feedback on the e-consent and answer any additional questions. The follow-up questionnaire is presented in Supplementary Figure 1. Participants were then given the option to provide full consent asynchronously over REDCap or schedule an in-person meeting with a coordinator. E-consent records were stored electronically on REDCap.
The main outcome of this study was acceptability of e-consent defined by the proportion of participants indicating preference to complete the full consent electronically. Additional measures of acceptability were participant ratings on (1) comfortability enrolling in the study before a follow-up call and (2) influence of a follow-up call on their initial decision to enroll. Ratings were measured with a 5-point Likert scale and multiple-choice format, respectively (Figure S1).
Statistical analysis
Acceptability of e-consent was analyzed using descriptive statistics. The association between participants’ comfortability with asynchronous e-consenting and their clinical and demographic characteristics was examined in bivariate analysis. Participant comfortability outcomes were dichotomized using 2-way contingency tables. Results were reported as odds ratios (ORs) with 95% confidence intervals (95% CIs). Significance was assessed using Fisher’s exact test (2-sided, α = 0.05). Statistical analyses were performed using R (version 4.4.2).
Results
Enrollment in VICTORI began in November 2022 with an e-consent data cutoff date of January 21, 2025, at which 134 patients were recruited. The proportion of patients at each stage of the e-consent process is shown in Figure 1. Briefly, 51 participants provided preliminary e-consent. Forty-seven participants (92%) fully consented to the study, 41 of which (87%) did so electronically. The median age of fully consented participants was 55 years old (range 29–91). Thirty-four were male (72%) and thirteen were female (28%). Four participants did not complete the full consent and were excluded from bivariate analysis. Of the 51 participants who completed the e-consent, 46 (90%) indicated a preference for an electronic full consent.
Figure 1.
Sankey diagram of stages of consent in VICTORI, including participants’ preferred method of full consent. Preference for full consent method was obtained during the follow-up call with a research coordinator. Participants who did not complete the e-consent also did not provide a preferred method for signing the full consent.
Complete questionnaire ratings for e-consent experience were available for 41 participants, which are depicted in Figure 2. Thirty-eight participants (93%) rated their comfortability enrolling in the study before the follow-up call either 4 (“high”) or 5 (“very high”) on a 5-point Likert scale. Thirty-three participants (81%) indicated that the follow-up call did not affect their decision to enroll. Across tumor site (PC, CRC), stage (I-III and IV), sex and age, ORs for participants’ comfortability with study enrollment using e-consent did not reach statistical significance. ORs for all associations are presented in Table S1.
Figure 2.
Participant ratings for acceptability of the preliminary e-consent. (A) Participant ratings of the follow-up call questions on a 5-point Likert scale. Participants were asked to rate their comfortability enrolling in the study after only viewing the e-consent and before receiving a follow-up call with a study member. (B) Influence of the follow-up call on participants’ decision to enroll compared to after watching the e-consent. All follow-up questions were administered over telephone by a research coordinator after e-consent completion.
Discussion
Our e-consent demonstrated strong acceptability among patients in the VICTORI study. Acceptability did not differ across clinical or demographic subgroups. Patients reported high levels of comfortability enrolling without a follow-up call and its limited utility in their consent decisions, supporting fully patient-led and asynchronous approaches.
Asynchronous strategies allow consent to be delivered on patients’ schedules and improve autonomy in their consent experience.5,6 The ability to recruit patients without live interaction also reduces the administrative burden and time for clinicians. In addition, video delivery standardizes the consent process.
Acceptability of e-consent has been previously demonstrated.5,6,8,9 However, most evidence comes from studies with limited relevance to participants (eg simulation studies), where acceptability may be overestimated because less value is placed on participation itself. We extend the evidence to a prospective clinical oncology study with prolonged future participation over several years.
A key limitation is that comprehension from e-consent was not measured. Whether asynchronous e-consenting can promote comprehension as effectively as traditional consent methods remains an important question. Additionally, e-consent implementation must adhere to local and international ethical standards. While e-consent was recognized in the 2024 revision of the Declaration of Helsinki,10 an asynchronous approach must still navigate regional legal and regulatory requirements. Future investigation of these limitations should be conducted in clinical trials where new enrollment strategies are needed most.
Supplementary Material
Acknowledgments
This work was supported by the BC Cancer Foundation. JML is a Michael Smith Health Professional Investigator which helps support his research. BJC is a CIHR Canada Graduate Research Scholarship—Master’s recipient which help support his research.
Contributor Information
Brendan J Chia, Medical Oncology, BC Cancer, Vancouver Cancer Centre, Vancouver, BC V5Z 1K1, Canada.
Joao Paulo Solar Vasconcelos, Medical Oncology, BC Cancer, Vancouver Cancer Centre, Vancouver, BC V5Z 1K1, Canada.
Daniela Hegebarth, Medical Oncology, BC Cancer, Vancouver Cancer Centre, Vancouver, BC V5Z 1K1, Canada.
Sophie Chuang, Medical Oncology, BC Cancer, Vancouver Cancer Centre, Vancouver, BC V5Z 1K1, Canada.
Gale Ladua, Medical Oncology, BC Cancer, Vancouver Cancer Centre, Vancouver, BC V5Z 1K1, Canada.
Marilyn Zhou, Medical Oncology, BC Cancer, Vancouver Cancer Centre, Vancouver, BC V5Z 1K1, Canada.
Howard Lim, Medical Oncology, BC Cancer, Vancouver Cancer Centre, Vancouver, BC V5Z 1K1, Canada.
Karamjit Gill, Medical Oncology, BC Cancer, Vancouver Cancer Centre, Vancouver, BC V5Z 1K1, Canada.
Carl J Brown, Department of Surgery, Providence Health-St Paul’s Hospital, Vancouver, BC V6Z 1Y6, Canada.
Renata Peixoto, Medical Oncology, BC Cancer, Vancouver Cancer Centre, Vancouver, BC V5Z 1K1, Canada.
Karen Gelmon, Medical Oncology, BC Cancer, Vancouver Cancer Centre, Vancouver, BC V5Z 1K1, Canada.
Jonathan M Loree, Medical Oncology, BC Cancer, Vancouver Cancer Centre, Vancouver, BC V5Z 1K1, Canada.
Author contributions
BJC: Conceptualization, funding acquisition, project administration, methodology, investigation, data curation, formal analysis, software, visualization, writing—original draft, writing—review & editing. JPSV: Project administration, investigation, supervision, review & editing. DH, SC, GL, MZ: Project administration, investigation, writing—review & editing. HL, KG, CJB, RP, KG: Investigation, validation, writing—review & editing. JML: Conceptualization, funding acquisition, resources, methodology, investigation, supervision, validation, writing—original draft, writing—review & editing.
Supplementary material
Supplementary material is available at The Oncologist online.
Funding
The role of the funder: The BC Cancer Foundation did not play a role in the design of the study, the collection, analysis, and interpretation of the data; the writing of the manuscript; and the decision to submit the manuscript for publication.
Conflicts of interest
JML has provided consulting to Amgen, Bayer, Merck, Pfizer, Novartis, Takeda, Ipsen and Taiho; research funding from AstraZeneca, Personalis, and Agenus.
JPSV has consulted for Pfizer, Incyte, Astellas and Ipsen. HL has consulted for Eisai, Taiho, Roche, BMS, Astellas, AstraZeneca, Merck, Beigene, Takeda, Amgen, Pfizer and Varian. KAG has consulted for AstraZeneca, Pfizer, Gilead, Celcuity, Novartis, Diachi, Merck, City of Hope, Rethink, Canadian Breast Cancer Network, Real Breast Cancer Alliance; research funding from AstraZeneca and BMS.
Data availability
The data underlying this article cannot be shared for the privacy of individuals that participated in the study. Future collaborations involving the de-identified patient-level data will be considered through written communication to the corresponding author. All summary-level data underlying this article are available in this article and in its supplementary online material.
References
- 1. Nathe JM, Krakow EF. The challenges of informed consent in high-stakes, randomized oncology trials: a systematic review. MDM Policy Pract. 2019;4:2381468319840322-2381468319840311. 10.1177/2381468319840322 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 2. Mahmud A, Zalay O, Springer A, Arts K, Eisenhauer E. Barriers to participation in clinical trials: a physician survey. Curr Oncol. 2018;25:119-125. 10.3747/co.25.3857 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 3. Mazzochi AT, Dennis M, Chun HYY. Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks—a systematic review of studies within randomized controlled trials. Trials. 2023;24:127. 10.1186/s13063-022-06959-6 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 4. Chalil Madathil K, Koikkara R, Obeid J, et al. An investigation of the efficacy of electronic consenting interfaces of research permissions management system in a hospital setting. Int J Med Inform. 2013;82:854-863. 10.1016/j.ijmedinf.2013.04.008 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 5. Abujarad F, Peduzzi P, Mun S, et al. Comparing a multimedia digital informed consent tool with traditional paper-based methods: randomized controlled trial. JMIR Form Res. 2021;5:e20458. 10.2196/20458 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 6. Chapman N, McWhirter R, Armstrong MK, et al. Self-directed multimedia process for delivering participant informed consent. BMJ Open. 2020;10:e036977. 10.1136/bmjopen-2020-036977 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 7. Solar Vasconcelos JP, Titmuss E, Navarro F, et al. Identifying the optimal post-surgical timing of molecular residual disease (MRD) detection in colorectal cancer (CRC) using an ultra-sensitive assay: Interim results from the VICTORI study. J Clin Oncol. 2025; 43(4_suppl):275. Presented at: 2025 ASCO Gastrointestinal Cancers Symposium; 2025 Jan 27; San Franscico, CA. [Google Scholar]
- 8. Rowbotham MC, Astin J, Greene K, Cummings SR. Interactive informed consent: randomized comparison with paper consents. PLoS One. 2013;8:e58603. 10.1371/journal.pone.0058603 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 9. Sonne SC, Andrews JO, Gentilin SM, et al. Development and pilot testing of a video-assisted informed consent process. Contemp Clin Trials. 2013;36:25-31. 10.1016/j.cct.2013.05.011 [DOI] [PMC free article] [PubMed] [Google Scholar]
- 10. World Medical Association. World medical association declaration of Helsinki: ethical principles for medical research involving human participants. JAMA. 2025;333:71-74. 10.1001/jama.2024.21972 [DOI] [PubMed] [Google Scholar]
Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Supplementary Materials
Data Availability Statement
The data underlying this article cannot be shared for the privacy of individuals that participated in the study. Future collaborations involving the de-identified patient-level data will be considered through written communication to the corresponding author. All summary-level data underlying this article are available in this article and in its supplementary online material.