TBCRC 057: Survey about willingness to participate in cancer clinical trials during the pandemic

Abstract

Background: Breast cancer patients experienced heightened anxiety during the pandemic. Also, modifications to clinical trial activities allowing for virtual platforms, local assessments, and greater flexibility were introduced to facilitate participation. We sought to evaluate the association between pandemic-related anxiety and willingness to participate in trials and how pandemic-era modifications to trial activities affect the decision to participate.

Methods: We conducted an online survey from August to September, 2021 of patients with breast cancer assessing pandemic-related anxiety; clinical trials knowledge and attitudes; willingness to participate during and before the pandemic; and how each modification affects the decision to participate. Fisher's exact tests evaluated differences in proportions and two-sample t-tests evaluated differences in means. The association of pandemic-related anxiety with a decline in willingness to participate during compared to prior to the pandemic was modeled using logistic regression.

Results: Among 385 respondents who completed the survey, 81% reported moderate-severe pandemic-related anxiety. Mean willingness to participate in a trial was lower during the pandemic than prior [2.97 (SD 1.17) vs. 3.10 (SD 1.09), (p < 0.001)]. Severe anxiety was associated with higher odds of diminished willingness to participate during the pandemic compared to prior (OR 5.07). Each of the modifications, with the exception of opting out of research-only blood tests, were endorsed by >50% of respondents as strategies that would increase their likelihood of deciding to participate.

Conclusions: While pandemic-related anxiety was associated with diminished willingness to participate in trials, the leading reasons for reluctance to consider trial participation were unrelated to the pandemic but included worries about not getting the best treatment, side effects, and delaying care. Patients view trial modifications favorably, supporting continuation of these modifications, as endorsed by the National Cancer Institute and others.

Keywords: COVID-19; breast cancer; clinical trials; pandemic; survey.

FIGURE 1

Consort diagram. Figure displays the numbers of respondents who opened the survey link, selected their preferred language for completing the survey (English or Spanish), answered the eligibility questions and who were ultimately eligible to participate.

FIGURE 2

Pandemic‐related anxiety according to whether or not willingness to participate in a trial declined during the pandemic. Figure displays box‐and‐whisker plots of pandemic‐related anxiety scores for respondents whose willingness to participate in a trial during the pandemic compared to prior to the pandemic declined (left) and for respondents whose willingness to participate in a trial during the pandemic compared to prior did not decline (right). Pandemic‐related anxiety was rated on an 11‐point scale (0‐no anxiety to 10‐worst anxiety possible). Willingness to participate in a clinical trial was assessed on a 5‐point scale from “0, not at all willing” to “4, definitely willing”. Respondents indicated their willingness to participate before and during the pandemic separately. Respondents diagnosed during the pandemic were asked to consider their willingness prior to the pandemic under the hypothetical condition that their diagnosis occurred prior to the pandemic. Prior trial participants were considered to have been “definitely willing” to participate before the pandemic and current trial participants were considered “definitely willing” to participate during the pandemic. Current trial participants whose participation began prior to the pandemic were considered to be “definitely willing” to participate both before and during the pandemic. Change in willingness to participate in a trial was calculated by subtracting the willingness to participate score before the pandemic from that during the pandemic, with negative values indicating a decline in willingness to participate in a trial during the pandemic compared to prior. Change in willingness was categorized as binary variable—decline in willingness versus no decline in willingness.

FIGURE 3

Reasons for reluctance to participate in clinical trials during the pandemic. Figure displays the percentage of the 185 respondents who were reluctant to participate in a clinical trial during the pandemic who selected each reason for their reluctance. Respondents could select >1 reason. Respondents who were not current trial participants and who indicated anything other than being “definitely willing” to participate during the pandemic were considered reluctant to participate during the pandemic.

FIGURE 4

The effect of pandemic‐era modifications to clinical trial activities on decision to participate in a trial during or after the pandemic. For each modification to clinical trial activities, the figure displays the proportions of respondents who indicated they would be much less likely to participate (orange), somewhat less likely to participate (khaki), would not affect the decision whether or not to participate (green), somewhat more likely to participate (blue) and much more likely to participate (pink) in a trial during or after the pandemic. Current trial participants were asked to consider how modifications would affect their decision to participate in a future trial. Percentages <15% are not displayed.