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Background This study examined racial/ethnic differences among patients in clinical trial (CT) enrollment, refusal rates, ineligibility, and desire to participate in research within the National Cancer Institute's Community Cancer Centers Program (NCCCP) Clinical Trial Screening and Accrual Log. Methods Data from 4509 log entries were evaluated in this study. Four logistic regression models were run using physical/medical conditions, enrollment into a CT, patient eligible but declined a CT, and no desire to participate in research as dependent variables. Results Age ≥ 65 (OR=1.51, CI: 1.28 -1.79), males (OR=2.28, CI: 1.92 – 2.71), and non-Hispanic black race (OR=1.53, CI: 1.2 – 1.96) were significantly associated with more physical/medical conditions. Age ≥ 65 was significantly associated with lower CT enrollment (OR=0.83, CI: 0.7 - 0.98). Males (OR=0.78, CI: 0.65 -0.94) and a higher grade level score for consent form readability (OR=0.9, CI: 0.83 - 0.97) were significantly associated with lower refusal rates. Consent page length ≥ 20 was significantly associated with lower odds of “no desire to participate in research” among CT decliners (OR=0.75, CI: 0.58 – 0.98). Conclusion : There were no racial/ethnic differences in CT enrollment, refusal rates, or “no desire to participate in research” as the reason given for CT refusal. Higher odds of physical/medical conditions were associated with older age, males, and non-Hispanic blacks. Better management of physical/medical conditions before and during treatment may increase the pool of eligible patients for CTs. Future work should examine the role of co-morbidities, sex, age, and consent form characteristics on CT participation.

Background Decades of effectiveness research has established the benefits of using patient decision aids (PtDAs), yet broad clinical implementation has not yet occurred. Evidence to date is mainly derived from highly controlled settings; if clinicians and health care organizations are expected to embed PtDAs as a means to support person-centered care, we need to better understand what this might look like outside of a research setting. Aim This review was conducted in response to the IPDAS Collaboration’s evidence update process, which informs their published standards for PtDA quality and effectiveness. The aim was to develop context-specific program theories that explain why and how PtDAs are successfully implemented in routine healthcare settings. Methods Rapid realist review methodology was used to identify articles that could contribute to theory development. We engaged key experts and stakeholders to identify key sources; this was supplemented by electronic database (Medline and CINAHL), gray literature, and forward/backward search strategies. Initial theories were refined to develop realist context-mechanism-outcome configurations, and these were mapped to the Consolidated Framework for Implementation Research. Results We developed 8 refined theories, using data from 23 implementation studies (29 articles), to describe the mechanisms by which PtDAs become successfully implemented into routine clinical settings. Recommended implementation strategies derived from the program theory include 1) co-production of PtDA content and processes (or local adaptation), 2) training the entire team, 3) preparing and prompting patients to engage, 4) senior-level buy-in, and 5) measuring to improve. Conclusions We recommend key strategies that organizations and individuals intending to embed PtDAs routinely can use as a practical guide. Further work is needed to understand the importance of context in the success of different implementation studies.

The purpose of this study was (1) to examine the association of race/ethnicity on clinical trial awareness, controlling for several sociodemographic, attitudinal, and knowledge variables, and (2) to inform future communication campaigns to increase clinical trial awareness and participation. Secondary analysis was conducted among 6,754 Hispanic, Black, and White adult respondents to the National Cancer Institute’s 2007 Health Information National Trends Survey (HINTS). The dependent variable was awareness of clinical trials. Logistic regression was used to examine possible correlates of clinical trial awareness including sociodemographics, trust of sources of health information, beliefs about safety of health information, family/personal history of cancer, health seeking information, and awareness of three health agencies. Compared with Whites, Blacks and Hispanics were significantly less likely to have heard of a clinical trial. Other significant correlates of clinical trial awareness included education, income, belief that health information is safely guarded, family history of cancer, awareness of the Centers for Disease control, trust of health information from the Internet and charitable organizations, and distrust of health information from religious institutions. Blacks and Hispanics are significantly less aware of clinical trials. Campaigns that exploit unique beliefs and delivery channels for racial/ethnic subgroups should be considered.