The informed consent document and process are an integral part of clinical research. Clinical trials, especially cancer prevention trials, need to not only address the required elements of consent, but also provide information in a clear and succinct manner that allows the prospective participant to weigh all potential risks and benefits, taking into account personal beliefs, values and expectations. This proposed study builds on the findings of our initial informed consent study supported by an R25 NCI grant (Impact of an Easy-to-Read Informed Consent Document, P. Raich, PI, 1 R25 CA72592). It will expand on the overall goal of making the consent document easier to read and understand by further lowering the readability to the 6th grade level and providing a supplemental audiotape. In addition, it will address suitability of the materials provided by incorporating principles and language reflecting cultural sensitivity to minority populations considering participation in clinical trials. We plan to test the modified version of the consent document and supplementary audiotape in a more socioeconomic and culturally diverse population than we were able to accomplish in our initial study, by inviting Veterans Administration clinical sites to participate. Furthermore, the clinical trial setting for this study is the recently initiated national SELECT prostate cancer prevention trial, as compared to cancer treatment trial participants in our initial study. Outcome measures explored and validated in our initial study will be complemented by several additional measures, including self-efficacy, cultural sensitivity and satisfaction with decision, as suggested by theoretical models of decision-making. We expect the results of this study to provide additional insight into the decision-making process and the format presentation of information required for men from diverse socioeconomic, educational and cultural backgrounds presented with the option of participating in a clinical trial for the prevention of prostate cancer.
| Coyne, Cathy A; Xu, Ronghui; Raich, Peter et al. (2003) Randomized, controlled trial of an easy-to-read informed consent statement for clinical trial participation: a study of the Eastern Cooperative Oncology Group. J Clin Oncol 21:836-42 |
