The proposed research will develop and validate (1) alternative methods for administering informed consent (IC) procedures to a diverse population of women at increased risk for breast cancer, and (2) standardized instruments to evaluate the effect of alternative methods on both comprehension and willingness to participate in research that includes screening for BRCA1/BRCA2 mutations. The proposed research focuses on the """"""""informed"""""""" part of informed consent and reflects the principles and methods of cognitive-based theories of decision making and risk communication. The study will be conducted in three stages. In stage 1, the investigators will compile and evaluate counseling protocols and IC forms used in previous research that involved BRCA1/BRCA2 screening. Those activities will result in the development of a control condition during stage 2 research that reflects """"""""best current IC practices."""""""" In addition, the investigators will develop two experimental conditions. Their content will come from a series of stage 2 activities that will include the deliberations of expert and lay panels; the investigators will use the methods of Fischhoff, Bostrom, and others to structure the presentation of information. Although the content will be held constant across the two experimental conditions, the material will be administered in different ways: (1) a counselor will administer the instrument using a computer-controlled instructional system to standardize the administration across counselors, and (2) the respondent will administer the instrument using a self-administered, interactive computer-assisted instructional system. Also, during stage 2, the investigators will develop and validate a standardized instrument to evaluate change in subjects' knowledge and beliefs about breast cancer and BRCA1/BRCA2 screening. Stage 3 research will use an experimental design that randomly assigns a sample of 456 first-degree relatives (FDRs) of women recently diagnosed with breast cancer to one of the three conditions. A standardized instrument will be administered to all women before they are assigned to and after they receive one of the IC conditions. Both process and outcome evaluation data will be collected. Outcomes will include changes in knowledge, attitudes, and beliefs about breast cancer and genetic screening as well as willingness to participate in a research study that would include BRCA1/BRCA2 testing.
| Gribble, J N (1999) Informed consent documents for BRCA1 and BRCA2 screening: how large is the readability gap? Patient Educ Couns 38:175-83 |
