12016 Background: Multiple myeloma (MM) is twice as common in African Americans (AA) as in Whites, yet AA make up only 5% of multiple myeloma (MM) clinical trial participants nationwide. Multiple studies have attempted to identify the reasons why AA are underrepresented in clinical trials and have discovered that sociodemographic factors, a lack of understanding, mistrust of sponsors, and a variety of opportunity barriers all contribute to AA underrepresentation in clinical trials. At one cancer center, African Americans make up 33% of those enrolled in MM clinical trials. To begin to account for this success in enrolling AA in myeloma clinical trials, a survey was designed to determine whether the major barriers to AA clinical trial participation existed at this cancer center. Methods: The survey was open to any AA patient who had consented to a clinical trial. The Trust in Medical Research scale (TMR) developed by Hall et al., the Human Connection (THC) scale developed by Mack et al., and the Duke Intrinsic Religiosity Scale (DUREL) were the three main scales used in the survey. Adapted assessment questions from Advani et al were used to assess the importance of side effects in deciding to participate in clinical trials. Results: We offered the study to 76 patients and 80% (61/76) participated. The mean TMR score was 15.0 which is significantly greater than the 11.6 score observed for AAs at other institutions (p < 0.001). The mean human connection score was 57.7 which is significantly greater than the 54.6 observed in the population of the Mack study, which accrued mostly white participants (p < 0.001). The Pearson correlation coefficient between the TMR score and the human connection score is 0.37, indicating a significant positive correlation between human connection scores and trust scores (p-value = 0.002). The average score for the intrinsic religiosity section of the DUREL scale was 13 (score of 15 indicates high religiosity). The average score of importance of side effects was 8.574, significantly higher than the Advani AA response of 6.7 (p-value < 0.001). Conclusions: African Americans enrolled in clinical trials at the high enrolling cancer center had higher THC and TMR scale scores than reported nationally, both helping to facilitate trial enrollment. The high intrinsic religiosity score observed suggests that high religiosity had no impact on clinical trial participation, nor did concern about side effects. Furthermore, a high THC score was associated with a high trust score. Since this THC scale assesses whether participants believe their doctors listen carefully, care about them, offer hope, provide clear explanations, and so on, establishing a human connection may be one way to increase AA trust in providers, increase AA clinical trial enrollment and overcome other barriers.
1562 Background: Although patient advocates have created templates for standard consent forms, assessing patient preferences for First in Human (FIH) and Window of Opportunity (WO) trials consents is important given their unique risks. FIH trials are the first time a drug is tested in humans. In WO trials, treatment naïve patients receive a therapeutic agent in the window of time between diagnosis and standard of care (SOC) surgery. Our goal was to determine patient-preferred presentation of important information in FIH and WO consent forms. Methods: The study consisted of two phases: (1) analysis of consents for FIH and WO oncology trials open at a cancer center between 2019 and 2022; (2) interview patients who had reviewed consents for FIH or WO trials during the consent process. FIH consents were analyzed for the location(s) of information stating that the study drug has not been tested in humans (FIH info). The WO consents were analyzed for the location(s) of information stating the risk that trial may delay SOC surgery (WO info). Participants were asked about their preferred placement of the information in their own trial’s consent form and whether the consent was clear. Interviews were audio-recorded and double coded. Consent form analysis was compared to patients’ preferences. Results: 25 consents [20 FIH; 5 WO] were analyzed. 19/20 FIH consent forms included FIH info, and 4/5 WO consent forms included WO info. 42 patients were approached [19 FIH; 23 WO]; 34 [17 FIH; 17 WO] participated. 12/17 (71%) WO participants thought that the trial explanation in the consent form was clear. Conversely, only 9/17 (53%) FIH participants found it clear. Conclusions: Patients preferred that the important FIH and WO information be placed early in the consent, though exactly where varied. 82% of FIH participants wanted FIH information in the purpose, while only 19% of WO participants clearly preferred that WO information be in the purpose, and 41% preferred WO information to remain in the risks section. Using consent templates that reflect patient preferences accurately is essential for ethical informed consent; however, a one-size fits all approach may not accurately capture patient preferences, so multiple templates may be necessary. [Table: see text]
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