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Soledad Jorge, Shatreen Masshoor, Heidi J. Gray, Elizabeth M. Swisher, and Kemi M. Doll

Background: Significant disparities exist in recruitment of minorities to clinical trials, with much of the prior literature focused on race/ethnicity only. Limited English proficiency (LEP) is a known barrier in healthcare that may also drive disparities in trial enrollment. We sought to determine participation rates in gynecologic oncology trials among patients with LEP and to explore barriers to their participation. Methods: In a retrospective cohort study, electronic health record data from >2,700 patients treated over 2 years at one academic gynecologic oncology practice were abstracted and the primary exposure of having LEP was identified. The primary outcome was enrollment in a clinical trial. Demographic, financial, clinical, and healthcare access–related covariates were also abstracted and considered as potential confounders in a multivariable logistic regression model. Age, race, ethnicity, and insurance status were further examined for evidence of effect modification. In addition, a survey was administered to all gynecologic oncology research staff and gynecologic oncology providers (n=25) to assess barriers to research participation among patients with LEP. Results: Clinical trial enrollment was 7.5% among fluent English speakers and 2.2% among patients with LEP (risk ratio, 0.29; 95% CI, 0.11–0.78; P=.007), and remained significantly lower in patients with LEP after adjusting for the identified confounders of Hispanic ethnicity and insurance payer (odds ratio, 0.34; 95% CI, 0.12–0.97; P=.043). There was a trend toward race and LEP interaction: Asian patients were equally likely to participate in research regardless of language fluency, whereas White and Black patients with LEP were less likely to participate than non-LEP patients in both groups (P=.07). Providers reported that the most significant barriers to enrollment of patients with LEP in research were unavailability of translated consent forms and increased time needed to enroll patients. Conclusions: Patients with LEP were 3.4 times less likely to participate in gynecologic oncology trials than fluent English speakers. De-aggregation of race, ethnicity, and language proficiency yielded important information about enrollment disparities. These findings offer avenues for future interventions to correct disparities.

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Kemi M. Doll, Sara Khor, Bridgette Hempstead, Julianna G. Alson, Liz Kellogg, Erika Wolff, David Flum, Scott Ramsey, and Barbara Goff

Background: A major contributor to the black-white mortality gap in endometrial cancer (EC) is late stage at diagnosis for black women, which may be driven by delays in diagnosis both prior to and after symptom disclosure. Methods: For phase 1, black women with EC were recruited through oncology clinics and a local cancer support group. In-depth interviews were conducted focused on experiences of menopause, postmenopausal bleeding (PMB), and symptom disclosure, and transcripts coded using directed content analysis. For phase 2, EC cases from 2001–2015 were identified in SEER-Medicare. Location, provider type, and dates of symptom report and diagnosis were defined by claims data. The diagnostic interval was then calculated and step-wise multivariate modeling used to determine factors associated with time to diagnosis. Results: Phase 1 included 11 black women from 4 states (WA, LA, GA, CA), ages 47–70, stages 1––3 at diagnosis, for a total of 147 pages of transcribed interviews. Most were insured, with access to routine medical care. Common themes were a lack of knowledge of normal vs abnormal menopausal symptoms and silencing about bleeding among friends and family. The predominant interpretation of PMB was a resumption of normal menstruation, leading to significant delay in symptom disclosure. Reporting to an MD was largely driven by increased severity of bleeding or the onset of pain. Phase 2 included 3,363 EC cases, with 293 (8%) black women. The median diagnostic interval was 28 days (IQR: 8–110 days). After adjusting for age, region, gynecologic history and other presenting symptoms, provider differences were noted with shorter time for ER MDs (84%; P<.01) and PCPs (16%; P=.05) vs OBGYN. Characterization of bleeding as ‘abnormal’ rather than ‘postmenopausal’ prolonged time to diagnosis by 60% (P<.001). Black race was associated with a 2.4-fold increased diagnostic time interval (P=.017). Step-wise modeling showed that this association was explained by differences in diagnostic work-up: Compared to those with a biopsy within 7 days of presentation, women who had an ultrasound or no procedures had longer intervals (42% and 99%, respectively) to diagnosis (P<.001 for all). Conclusion: Among black women with access to medical care, there are modifiable factors that contribute to delays in diagnosis of EC both prior to and after symptom disclosure to a physician. This is the first study to identify targets for intervention to reduce the mortality rate in this high-risk group.