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Association of Remote Technology Use and Other Decentralization Tools With Patient Likelihood to Enroll in Cancer Clinical Trials

Key Points Question What is the association of remote technology and other decentralization tools with patient likelihood to enroll in cancer clinical trials? Findings In this cross-sectional survey study of 1183 patients with cancer and survivors of cancer, self-reported patient disposition toward enrollment in cancer clinical trials increased for modifications using remote technology and other decentralization tools. The majority of respondents (60%-85%) reported being more likely to enroll if the participation-related time and travel burden decreased as a result of these practices. Meaning These findings suggest that greater adoption of practices that reduce patient time and travel burden associated with clinical trial participation could improve enrollment in cancer trials.


Introduction
Adequate enrollment of participants in cancer clinical trials is essential for trial success and for advancing new standards of cancer care. Inadequate enrollment can lead to trial failure 1 or affect the interpretation of study results. 2 Even when recruitment is successful, cancer trials often do not reflect the diversity of the US population diagnosed with cancer, 3,4 which can limit the generalizability of results and lead to an unequal benefit in treatment advancements. The  pandemic has disrupted all aspects of cancer clinical research, including enrollment in trials, 5 as many ongoing trials were suspended and the start of planned studies was delayed. 6 In an effort to reduce the risks of SARS-CoV-2 transmission to patients and research staff and to move research forward, the US Food and Drug Administration 7 and the National Cancer Institute 8,9 issued guidance for trial investigators on clinical trial conduct for the duration of the federal Coronavirus Disease 2019 Public Health Emergency (PHE). This guidance provided flexibility for the adoption of methods to facilitate trial decentralization through the remote collection of trial data 8,9 outside of a standard, in-person, centralized clinical trial assessment site. These methods included use of virtual clinic visits, delivery of investigational products to the home, and use of alternative laboratories or imaging centers.
Although most patients accept when offered to participate in cancer clinical trials, 10 logistical challenges such as travel time and distance to a trial site are often a barrier to patient enrollment. [11][12][13] Decentralization of clinical trials beyond the PHE could provide an opportunity to increase access to and enrollment in available trials by reducing the participant time and travel burden. The effects of remote technology and other decentralization tools on the likelihood to increase patient disposition toward participation in cancer clinical trials are not yet well understood. This study aimed to assess the association of remote technology and other decentralization tools used to reduce time and travel related to clinical trial participation with patient likelihood to enroll in cancer trials.

Methods
The cross-sectional survey study was deemed exempt by the Morehouse School of Medicine Institutional Review Board. Participant informed consent was obtained electronically. Participation was voluntary and could be withdrawn at any time. This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline for cross-sectional studies where applicable.
Participants were included from the American Cancer Society Cancer Action Network's Survivor Views panel and augmented with commercially available web survey panels. Panelists were aged 18 years or older, had been diagnosed with and/or treated for cancer within the past 7 years, and were US residents. A series of questions were designed regarding telehealth, remote care technologies, and willingness to participate in cancer clinical trials (eMethods in the Supplement). These questions were incorporated into the existing survey program and sent to 1269 Survivor Views participants between July 6 and September 8, 2021, and to an undefinable number of commercial web survey panelists who were contacted through a Dynata panel. A total of 591 Survivor Views responses were received for an estimated response rate of 46.5% from the panel. The response rate for the remaining 592 responses obtained via other sources was undefinable because it is unclear how many received the invitation to participate, owing to uncertainty of email delivery status. Socioeconomic data, including race and ethnicity defined by the investigator, were identified by self-report and were accessed to ascertain differential associations of trial decentralization by socioeconomic factors. We classified race into 6 categories: American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, White, or declined to answer. We classified ethnicity into 3 categories: Hispanic, Latino/Latina, or Spanish origin (yes or no) or declined to answer.

Statistical Analysis
For comparisons of statistical significance, we used independent t tests for means and independent z tests for percentages. Statistical significance was set at α = .05. All statistical analyses were performed with IBM SPSS, version 27.

Results
The 1183 survey respondents had a mean (SD) age of 58.  (Figure 1).
Many respondents had already begun engaging in remote care outside of a clinical trial. For example, 520 (44%) had previously participated in a video visit with a health care practitioner for an issue related to their cancer for which they would have otherwise had to go into the office. These Additional effort is defined in terms of frequency of visits or travel to a more distant location to participate in a cancer clinical trial compared with the site where regular care is provided. experiences were overwhelmingly positive, with 496 respondents (95%) reporting that their issues and questions were well addressed during the video visit.
Respondents were asked about their general willingness to adopt technologies and tools related to remote care not specifically within the clinical trial context. They were subsequently asked whether the adoption of these technologies and tools by a trial that would otherwise require more distant travel would make them more likely to enroll. More than 80% of respondents (range, 999-1033) expressed willingness to adopt the majority (6 of 8) of remote interventions (Figure 2); similarly, the use of these interventions was associated with an increase in self-reported likelihood to enroll in a trial among a majority of respondents (range, 60%-85%) (Table). The proposed modifications were associated with an increase in willingness to enroll by the greatest amount among respondents who expressed the highest interest in enrolling in a trial absent such modifications (range, 429-509 [77%-91%]), but increases in willingness were reported by all groups, even among those who initially reported that they would not join a clinical trial under any circumstances (range,

Discussion
The results of this cross-sectional survey study suggest that most patients with cancer and survivors of cancer are willing to participate in cancer clinical trials if recommended by their health care practitioner, even if participation requires additional effort in terms of frequency of visits or travel to a more distant location compared with their regular health care practitioner. However, willingness to participate in trials requiring additional effort varies by income and age, with lower-income earners and older respondents less likely to travel farther or attend more frequent visits. Previous research has established a higher travel burden experienced by patients living in low-income areas and enrolled in trials 14