A Videotape to Increase Cancer Clinical Trials Particip*

描述（由申请人提供）： 癌症治疗的重要进展只能通过良好的临床试验来实现。然而，尽管有大量的研究，只有5%的新癌症患者参加临床试验（哈里斯互动，2001年1月）。特别是，非裔美国人在癌症临床试验中的代表性不成比例地低，他们的癌症死亡率比白人高出近35.4%（SEER 1973-1996 Cancer Statistics Review，1999）。为了加快开发新的癌症治疗方法，并确保临床试验结果在所有种族群体中有效和适用，需要新的策略来增加临床试验的参与，特别是在非洲裔美国人中。 一些研究已经证明，缺乏信息是患者参与临床试验的一个重要障碍。由于了解到生物医学研究中侵犯人类受试者权利的历史而产生的恐惧也被认为是参与的一个障碍。在这项研究中，我们将测试教育视频的有效性，旨在反映患者人群的文化多样性，增加乳腺癌患者对临床试验的知识和意识，从而增加参与。研究人群将包括Karmanos癌症研究所多学科肺部诊所的非裔美国人和高加索女性浸润性肺癌患者。200名新患者将被随机分配到对照组或干预组。所有研究参与者将在第一次和第二次临床访视时完成一份问卷，以测量他们对临床试验的知识和态度。在两次测试之间，对照组的患者将接受当前标准的护理，而干预组的患者将获得视频进行审查，然后在接受当前标准的护理之前与肿瘤科护士进行5到10分钟的讨论。我们的假设是，教育录像带将增加患者的知识和促进积极的态度，对癌症临床试验，从而增加试验的参与。

DESCRIPTION (provided by applicant): Important advances in cancer treatments can only be achieved through well-conducted clinical trials. However, despite the large number of available studies, only five percent of new cancer patients participate in clinical trials (Harris Interactive, January 2001). In particular, African Americans' representation in cancer clinical trials is disproportionately low, and their cancer mortality rate is nearly 35.4 percent higher than that of whites (SEER 1973-1996 Cancer Statistics Review, 1999). To speed up the development of new cancer treatments and to ensure that clinical trial results would be valid and applicable across all racial groups, new strategies are needed to increase clinical trials participation particularly in the African American population. Several studies have documented that lack of information is a significant patient-level barrier to clinical trial participation. Fears based on awareness of a history of abuses of the rights of human subjects in biomedical research is also believed to be a barrier to participation. In this study, we will test the effectiveness of an educational video, designed to reflect the cultural diversity in patient population, in increasing breast cancer patients' knowledge and awareness about clinical trials and thus increasing participation. The study population will include both African American and Caucasian women with invasive lung cancer who are new to the Multidisciplinary Lung Clinic at the Karmanos Cancer Institute. Two hundred new patients will be randomized to either the control arm or the intervention arm. All study participants will complete a questionnaire to measure their knowledge and attitudes toward clinical trials, at their first and second clinic visit. Between the two testings, patients in the control arm will receive the current standard of care, while patients in the intervention arm will be given the video to review followed by a five to ten minute discussion with an oncology nurse before receiving the current standard of care. Our hypothesis is that the educational videotape will increase patients' knowledge and promote positive attitudes toward cancer clinical trials and thereby increase trial participation.