DESCRIPTION (provided by applicant): Randomized controlled clinical trials are universally viewed as the gold standard for evidence-based medicine and the most powerful tool available to evaluate interventions for possible incorporation into clinical practice. Despite the importance of this research, it has been estimated that only 3 percent of adult cancer patients participate in these studies. There is a multitude of reasons why patients are not enrolled in clinical trials, however the complexity and time demands of the informed consent process make it one of the major obstacles in increasing trial accrual. The specific aim of this application is to create a new model for assisting patients and physicians with the informed consent process. Video is the optimal media to utilize for this purpose because it allows the replication of the most familiar and effective means of traditional patient education -- a physician speaking to a patient. DVD is a major technologic advance in the delivery of video for educational purposes, because it allows random access, providing the viewer with the opportunity to utilize specific segments of interest. The recent widespread dissemination of DVD players and the rapid decrease in cost make this approach much more attractive.
We propose the development of a pilot DVD composed of approximately two hours of video interviews divided into easily accessed chapters. The focus of this pilot project will be an important new Phase III randomized trial that has just been launched by the National Surgical Adjuvant Breast and Bowel Project (NSABP). The NSABP B-35 trial will randomize approximately 3,000 women with Ductal Carcinoma In Situ (DCIS) to either the nonsteroidal aromatase inhibitor, anastrozole or tamoxifen. Interviewees on the DVD will include surgical oncologist Dr Richard Margolese (principal investigator of this trial), a medical oncologist and an oncology research nurse who are participating in the study (to be determined) and three breast cancer survivors who participated in previous Phase III adjuvant trials. Medical oncologist, Dr Neil Love, founder and president of NL Communications will host the DVD video program. NL Communications has more than 20 years experience in breast cancer education and currently produces a family of CME-certified oncology products funded by several major pharmaceutical companies. Independent market research has confirmed that 65% of US-based oncologists currently utilize these NL's educational programs. The intent of the DVD program is to provide useful information and perspectives to breast cancer patients related to B-35 and to facilitate (not replace) the informed consent process. In addition, the product will be evaluated in terms of the potential to save physicians' and nurses' time, and ultimately improve clinical trial accrual.
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