Despite descriptive work documenting that patients do not fully understand the nature of early phase clinical research, little work has been conducted testing interventions designed to enhance patients' understanding, a critical element of the informed consent process. Patient activation is an inexpensive intervention that has been used effectively in the health education arena, but has never been tested in early phase clinical trials. In the proposed study, patients eligible for early phase clinical trials in oncology and infectious disease clinics at the John Hopkins Hospital and Duke University Medical Center will be randomized either to receive or not receive a short, self-directed, computer-based educational intervention concerning the nature of clinical research before their appointment with the physician. In addition to describing the purpose of early phase trials, the intervention will include an """"""""activation"""""""" component, meaning that questions will be suggested that patients might want to ask physician-investigators during their appointment. Discussions between physicians and patients will be audiotaped and analyzed using previously validated techniques to determine the effect of the intervention on doctor-patient interactions, including whether there are changes in the ratio of """"""""doctor-speak"""""""" to """"""""patient-speak"""""""" and in the amount of question asking by patients. Patients will be interviewed after these discussions, using quantitative and qualitative methods, to examine the degree to which the intervention and/or different styles of communication affect patient understanding, patients' expectation for personal medical benefit, patient enrollment, reasons for participating, patients' decisional commitment, satisfaction and trust in the process. Later in the study, aggregate feedback will be given to physician-investigators concerning what was learned in the analyses of physician-patient interactions and from patient interviews. The research may determine whether providing this simple feedback intervention to physician-investigators has an effect above and beyond any effect seen by providing an """"""""activation"""""""" intervention to patients alone.
| Kass, Nancy E; Sugarman, Jeremy; Medley, Amy M et al. (2009) An intervention to improve cancer patients' understanding of early-phase clinical trials. IRB 31:1-10 |
| Sugarman, Jeremy; Kass, Nancy; Faden, Ruth (2009) Categorizing empirical research in bioethics: why count the ways? Am J Bioeth 9:66-7 |
| Kass, Nancy; Taylor, Holly; Fogarty, Linda et al. (2008) Purpose and benefits of early phase cancer trials: what do oncologists say? What do patients hear? J Empir Res Hum Res Ethics 3:57-68 |
