Wells Kristen J, McIntyre Jessica, Gonzalez Luis E, Lee Ji-Hyun, Fisher Kate J, Jacobsen Paul B, Meade Cathy, Muñoz-Antonia Teresita, Quinn Gwendolyn P
aDepartment of Psychology, San Diego State University, San Diego, CA, USA.
Clin Trials. 2013 Oct;10(5):767-74. doi: 10.1177/1740774513495984. Epub 2013 Aug 9.
Hispanic cancer patients are underrepresented in clinical trials; research suggests lack of knowledge and language barriers contribute to low accrual. Multimedia materials offer advantages to Hispanic populations because they have high acceptability, are easy to disseminate, and can be viewed with family.
Hispanic cancer patients and caregivers participated in focus groups to aid in developing a Spanish-language multimedia intervention to educate Hispanic cancer patients about clinical trials. We explored the feasibility of delivering the intervention in medical oncology clinics.
A total of 35 patients were randomized to either the multimedia intervention group (n = 18) or a control group (n = 17) who were asked to read the National Cancer Institute's Spanish-language clinical trials brochure. Self-reported data on knowledge about and attitudes toward clinical trials, self-efficacy for participating in a clinical trial, intention to participate in a clinical trial if asked, and receptivity to information about a clinical trial were collected at baseline and 10 days later.
Delivery of the multimedia presentation in oncology clinics was feasible. The intervention group had more knowledge about clinical trials at follow-up than the control group; scores for intention to participate in a clinical trial by participants in the intervention group increased from 3.8 to 4.0 of a possible 5, but declined in the control group from 4.5 to 4.1. No statistically significant difference was detected between groups in scores for attitudes or self-efficacy for making a decision to participate in a clinical trial.
Our sample size was inadequate to identify differences between the informational methods. Although all patients were asked about their willingness to participate in a clinical trial, this decision was hypothetical. In addition, the study was conducted with a sample of Spanish-speaking Hispanic cancer patients at a comprehensive cancer center in Florida. Thus, the results may not generalize to other Hispanic populations.
In the pilot project, we demonstrated the feasibility of delivering multimedia information to patients in medical oncology clinics. Because delivery in a clinical setting was found to be feasible, a larger study should be conducted to evaluate the efficacy of the multimedia intervention with respect to promoting accrual of Hispanic patients to clinical trials.
西班牙裔癌症患者在临床试验中的代表性不足;研究表明,知识缺乏和语言障碍导致入组率较低。多媒体材料对西班牙裔人群具有优势,因为它们具有较高的可接受性,易于传播,并且可以与家人一起观看。
西班牙裔癌症患者及其护理人员参与了焦点小组,以协助开发一种西班牙语多媒体干预措施,用于对西班牙裔癌症患者进行临床试验教育。我们探讨了在肿瘤内科诊所提供该干预措施的可行性。
总共35名患者被随机分为多媒体干预组(n = 18)或对照组(n = 17),后者被要求阅读美国国立癌症研究所的西班牙语临床试验手册。在基线和10天后收集关于临床试验的知识和态度、参与临床试验的自我效能感、如果被邀请参与临床试验的意愿以及对临床试验信息的接受度的自我报告数据。
在肿瘤内科诊所提供多媒体演示是可行的。干预组在随访时对临床试验的了解比对照组更多;干预组参与者参与临床试验的意愿得分从可能的5分中的3.8分提高到4.0分,但对照组从4.5分下降到4.1分。在参与临床试验决策的态度或自我效能感得分上,两组之间未检测到统计学上的显著差异。
我们的样本量不足以识别信息方法之间的差异。尽管所有患者都被问及参与临床试验的意愿,但这一决定是假设性的。此外,该研究是在佛罗里达州一家综合癌症中心对说西班牙语的西班牙裔癌症患者样本进行的。因此,结果可能不适用于其他西班牙裔人群。
在该试点项目中,我们证明了在肿瘤内科诊所向患者提供多媒体信息的可行性。由于发现在临床环境中提供是可行的,因此应该进行更大规模的研究,以评估多媒体干预措施在促进西班牙裔患者参与临床试验方面的效果。