Mead‐Harvey, Carolyn

Abstract Background: Historically, less than 10% of adult patients with cancer enroll in clinical trials, however, enrollment dropped further at the onset of the COVID-19 pandemic. Barriers to trial participation during the pandemic have not been reported. As part of the TBCRC 057 survey on the impact of the pandemic on willingness to participate in breast cancer trials, we assessed reasons for reluctance to participate in trials during the pandemic. Methods: US residents who self-reported a breast cancer diagnosis were eligible to complete the online survey 8/6/21-9/30/21. Respondents indicated whether they were current trial participants and, if not, their willingness to consider participating in a trial during the pandemic using a 5-point scale (0-not at all willing to 4-definitely willing). Respondents who were not current trial participants and who were not “definitely willing” to consider participation during the pandemic were characterized as “reluctant” and asked to select reasons for their reluctance from a checklist. Pandemic-related anxiety was assessed on an 11-point scale (0-no anxiety to 10-worst anxiety possible). Respondents indicated how the option to conduct trial activities online would affect their decision to participate in a trial (much less likely, somewhat less likely, would not affect my decision, somewhat more likely, or much more likely). In exploratory analyses, we evaluated whether pandemic-related anxiety and favorable reactions towards opportunities to conduct trial activities online were associated with reluctance to consider trial participation during the pandemic due to fear of SARS-CoV-2 exposure. Means were compared with two sample t-tests and proportions with Fisher’s exact tests. Results: Of 385 survey respondents, 185 (48%) were characterized as reluctant to consider trial participation during the pandemic. Among these 185, median age was 55 (range 25-80), 85.7% were non-Hispanic White, 48.1% had metastatic disease and 44.2% received care at academic centers. Reasons for reluctance to consider trial participation during the pandemic cited by ≥15% of the 185 reluctant respondents are shown in the Table. Respondents who selected fear of exposure to SARS-CoV-2 as a reason for their reluctance to consider participating in a trial during the pandemic had higher mean pandemic-related anxiety (7.0 vs 5.2, p< 0.001). These respondents were more likely to indicate telemedicine doctor visits (p=0.01), virtual consents (p=0.001) and online study questionnaires (p=0.001) would make them somewhat or much more likely to participate in trials than respondents who did not select fear of exposure to SARS-CoV-2 as a reason for their reluctance. Conclusions: Reasons for reluctance of patients with breast cancer to consider participation in clinical trials during the pandemic are multifactorial. Although concerns about safety and efficacy remain prominent, fear of exposure to SARS-CoV-2 drives unwillingness to participate in >25% of reluctant patients. Trial accrual may benefit from incorporation of electronic activities when possible. Table Citation Format: Karen L. Smith, Carolyn Mead-Harvey, Gina L. Mazza, Albert E. Holler, Eileen Shinn, Elizabeth Frank, Michelle Melisko, Cyd Eaton, Jeannine M. Salamone, Teri Pollastro, Patricia Spears, Antonio C. Wolff, Gabrielle B. Rocque. Reasons for Reduced Willingness to Participate in Clinical Trials During the COVID-19 Pandemic: The Translational Breast Cancer Research Consortium (TBCRC) 057 Survey [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P6-08-07.

97 Background: In order to maintain safety, clinical trial activities have been modified during the COVID-19 pandemic. As part of the TBCRC 057 survey, we assessed how pandemic-related modifications to trial activities affect breast cancer patients’ willingness to participate in clinical trials. Methods: US residents with breast cancer were eligible to complete the online survey 8/6/21 – 9/30/21. Respondents rated whether each of 11 modifications to clinical trial activities would affect their decision to participate in a trial during or after the pandemic. Items evaluated modifications that involved changing the location of trial activities to closer to home, switching trial activities to telemedicine and making the trial schedule more flexible and convenient. Response options were “much less likely to participate”, “somewhat less likely to participate”, “would not affect my decision whether or not to participate”, “somewhat more likely to participate” and “much more likely to participate”. Current trial participants were asked to consider how modifications would affect their decision to participate in another trial. Results are reported descriptively. Results: Among 385 respondents, median age was 52 (range 25-85), 88.6% were non-Hispanic White, 52.5% had metastatic disease, 93% were receiving active treatment, 48.6% received care at an academic center and 9.6% were current trial participants. Changing location of trial activities was viewed favorably, with 70.2%, 64.6% and 54.1% of respondents indicating they would be much or somewhat more likely to participate if they could complete trial blood tests, x-ray tests or doctor visits closer to home, respectively. Similarly, the option to complete trial activities electronically was viewed favorably, with 59.6%, 58.6% and 60.9% of respondents indicating they would be much or somewhat more likely to participate if they could complete trial doctor visits, consent and questionnaires via telemedicine, respectively. With regard to modifications to make the trial schedule more flexible and convenient, respondent feedback was also favorable. 71.4%, 67.7% and 82.4% of respondents indicated that requiring study site visits no more than once per 3 weeks, widening windows for trial activities and offering home delivery of oral study medications, respectively, would make them much or somewhat more likely to participate. Finally, 30.4% and 51.7% indicated that the flexibility to opt-out of research-only blood tests and biopsies, respectively, would make them much or somewhat more likely to participate. Conclusions: Patients view modifications to trial activities implemented during the pandemic favorably. Trials should be flexible and the option to conduct study activities close to home or electronically when possible should be maintained during the pandemic and beyond.

PURPOSE: Financial hardship (FH) in cancer care is a growing challenge for patients, their caregivers, and health care providers with impact on morbidity and mortality. In this study, we report on a standardized approach to describe the prevalence and predictors for FH as part of routine clinical workflow. We also report on the association of FH with survival in our cancer patient population. METHODS: This study includes patients who completed a FH screen at least once between 2018 and 2020. Demographics, disease state, and mortality data were extracted from the medical records. Multivariable logistic regression models were used to examine association of sociodemographic and disease variables with FH. By using propensity score weighting to account for differences in demographic and clinical factors between patients with and without FH, we then fit Cox proportional hazards models to examine the relationship between FH and survival. RESULTS: The study cohort included 31,154 patients. FH was reported by 14% (n = 4,250) of the patients. A significantly higher likelihood of having FH ( P < .001 for all) was reported by racial/ethnic minority patients; those who were unemployed/disabled, single, or divorced; patients from disadvantaged neighborhoods; and those who were self-pay or had government insurance. Older age, being retired, and living farther from the cancer center were associated with significantly less likelihood of endorsing FH. Patients who endorsed FH had a lower survival (hazard ratio for mortality 1.46). CONCLUSION: Our study identified key groups more likely to report FH in a relatively affluent population at a large cancer center and showed an adverse association between FH and survival. Further research is needed to develop clinical care pathways for patients at high risk for worse financial and clinical outcomes.

Introduction: Clue cells result from aberrant vaginal microflora and are associated with an increased vaginal pH, which can allow colonization of uropathogens in the vaginal introitus, increasing the risk for urinary tract infections (UTI). We sought to determine whether clue cells on vaginal wet preparation in the emergency department (ED) are associated with emergency physician diagnoses of UTIs and positive urine cultures. Methods: We conducted a retrospective analysis examining a dataset of women (≥18 years of age) who received both a genital wet preparation and urine testing in the ED. Both chi-square and multivariable regression analysis were performed. Results: We analyzed 14,952 encounters. On both univariable and multivariable analyses, emergency physicians diagnosed significantly fewer clue cell-positive women with a UTI (10.9% diagnosed with UTI vs 13.1% without UTI) (P <.001). Women with clue cells on vaginal wet preparation were not more likely to have a positive urine culture or have a urine culture growing Escherichia coli. Pregnant women with clue cells on vaginal wet preparation were not more likely to have a UTI or have a positive urine culture. Conclusion: Emergency physicians diagnosed significantly fewer women with UTIs when they found clue cells on vaginal wet preparation. Clue cells on vaginal wet preparation were not associated with an increased likelihood of a positive urine culture or having E. coli growing in the urine.

e19078 Background: Patients with myeloproliferative neoplasms (MPN), including polycythemia vera (PV), essential thrombocythemia (ET), and myelofibrosis (MF), experience chronic disease-related symptoms. Surveying these patients while incorporating the MPN-Symptom Assessment Form (SAF) gains valuable insight. Independent surveys evaluating symptoms among MPN patients have seen disproportionate participation among females compared to males (upwards of 4:1). Though the general MPN patient population is roughly gender balanced, epidemiological studies show the occurrence of MPN types differ between men and women (MPN [%male]: PV [65%], ET [33%], MF [50%]. Mehta, et al. Leuk & Lymph 2014). In-clinic evaluations and international MPN surveys of disease-related symptoms suggest women report higher symptom burden on average compared to men, despite MPN type [Emanuel, et al. JCO 2012. Geyer, et al. Haematol 2017]. Further, a recent study across cancer trials showed women had a 34% increased risk of reporting severe symptoms [Unger, et al. JCO 2022]. This study aimed to evaluate gender imbalance in survey participation among MPN patient surveys and investigate its potential to overestimate symptom burden if gender is ignored. Methods: Five anonymous web-based surveys were used to assess the impact of disproportionate gender participation. The MPN-10 assessing the 10 most clinically meaningful SAF items was present in these surveys and generated the Total Symptom Score (TSS). Survey responses with no self-reported gender or ≥5 missing MPN-10 symptoms were excluded. Raking weights based on expected MPN population were applied at the survey- and MPN type-level. Relative bias of mean TSS was calculated to evaluate over- and underestimation due to this participation imbalance. Relative bias <5% is commonly acceptable. Results: There were 4962 survey participants total and 74% were female (Table). Epidemiologically expected gender frequency by MPN type was not seen (MPN [%male]: PV [31%], ET [15%], MF [37%]). The gender participation imbalance accounted for a 3.1% overestimation of overall TSS. This also resulted in a 6.8% underestimation of the mean difference in TSS between genders, across MPNs. Conclusions: Overall bias due to gender participation imbalance was relatively low. However, analyses considering gender differences were more impacted. Anonymous surveys should seek to reduce participation bias during the survey design phase. More research is needed to evaluate gender and other participation biases in surveys across cancer domains.[Table: see text]

1564 Background: Enrollment in clinical trials has declined during the COVID-19 pandemic. Simultaneously, breast cancer patients have reported heightened anxiety. We assessed whether breast cancer patients’ anxiety about the pandemic affects their willingness to participate in trials. Methods: English or Spanish-speaking US residents with breast cancer were eligible to complete the online REDCap survey 8/6/21 – 9/30/21. Respondents rated their anxiety about the pandemic on an 11-point scale from 0 (no anxiety) to 10 (worst anxiety possible). Anxiety scores were categorized as no/mild (0-3), moderate (4-6) or severe (7-10). Knowledge about trials was assessed with 11 true/false items and attitudes toward trials with the Attitudes Toward Cancer Trials Scales - Cancer Treatment Subscale (ATCTS-CTS). Respondents rated their willingness to participate in a breast cancer clinical trial before and during the pandemic on 5-point scales from 0 (not at all willing) to 4 (definitely willing). Trial participants were considered “definitely willing.” Change in willingness to participate in trials during the pandemic compared to prior was defined as a binary outcome, "less willing" vs "no less willing." Means were compared via t-test and mean difference was tested via paired t-test. Multivariable logistic regression was used to model the association of anxiety and other factors with being less willing to participate in trials during compared to prior to the pandemic. Results: Among 385 respondents, median age was 52 (range 25-85), 271 (70%) were non-Hispanic White and 202 (53%) had metastatic disease. 154 (40%) received care at academic centers and 37 (10%) were current trial participants. Most rated their anxiety as moderate (43%) or severe (38%). Mean willingness to participate in a trial was lower during compared to prior to the pandemic (2.97 vs 3.10; p < 0.0001). Fifty (13%) respondents were less willing to participate in a trial during the pandemic compared to prior. After controlling for covariates, those with severe anxiety had 5.07 times odds of being less willing to participate during the pandemic compared to prior than those with no/mild anxiety (p = 0.01). For every 1-point increase in ATCTS-CTS score (indicating better attitude toward trials) there was a 3% decrease in the odds of being less willing to participate during the pandemic (p = 0.006). For every 1-point increase in the clinical trials knowledge score (indicating more knowledge) there was a 15% decrease in the odds of being less willing to participate during the pandemic (p = 0.02). Conclusions: Pandemic-related anxiety is common in breast cancer patients and is associated with being less willing to participate in trials during the pandemic compared to prior. Education about trials, including safety modifications implemented during the pandemic, may mitigate anxiety and improve willingness to participate.