VIDEOTAPE FOR RECRUITMENT TO ONCOLOGY CLINICAL TRIALS

患者参与临床试验是一个难题。一直以来 估计#年NCI支持的癌症治疗试验的总收益 成人占潜在患者数量的一小部分(&lt；10%) 可用。进一步估计，合作集团佐剂 试验增加了1%到1.5%的潜在可用患者。三大 NCI支持的研究的平均比率分别为32%、113%和119% 比计划的预测速度慢。这个SBlR的目的是 制作和评估一盘录像带，用于招募癌症患者 临床试验。录像带的具体目的是：(1)增加 招募病人参加癌症临床试验；(2)增加 患者对参与治疗的认识和满意度 临床试验；以及(3)提供具有成本效益的、标准化的 临床试验的招募策略。这些目标将会实现 通过开发一盘录像带。这盘录像带将作为 描述临床试验和解决患者问题的教育工具 对参与的恐惧和担忧。在建议的第一阶段 我们将确定录像带的内容需求和最 有效的演示方法。在第二阶段，录像带将被 制作和评估。这个SBIR的最终产品将是一盘录像带 这可用于临床试验的招募。虽然建议的 将在乳腺癌的背景下开发和测试录像带 临床试验，开发的方法将可移植到其他 临床试验。

Patient accrual to clinical trials is a difficult problem. It has been estimated that total accrual to NCI-supported cancer treatment trials in adults represents a fraction (<10%) of the number of patients potentially available. It has been further estimated that Cooperative Group adjuvant trials accrue 1% to 1.5% of potentially available patients. Three major NCI supported studies had average rates that were 32%, 113%, and 119% slower than planned projection rates. The purpose of this SBlR is to develop and evaluate a videotape for recruiting patients to cancer clinical trials. The Specific Aims of the videotape are: (1) To increase recruitment of patients to cancer clinical trials; (2) To increase patient's understanding of and satisfaction with their participation in clinical trials; and (3) To provide a cost-effective, standardized recruitment strategy for clinical trials. These aims will be accomplished through the development of a videotape. This videotape will serve as an educational tool to describe clinical trials and to address patient's fears and concerns regarding participation. During Phase I of the proposed SBlR we will determine the content needs of the videotape and the most effective presentation method. During Phase II, the videotape will be produced and evaluated. The end product of this SBIR will be a videotape that can be used for recruitment to clinical trials. While the proposed videotape will be developed and tested in the context of breast cancer clinical trials, the method developed will be transferable to other clinical trials.