Date of this Version
Krieger, J. L., Palmer-Wackerly, A. L., Dailey, P., Krok, J., Schoenberg, N., & Paskett, E. (2015). Comprehension of randomization and uncertainty in cancer clinical trials decision-making among rural, Appalachian patients. Journal of Cancer Education (early online edition). doi: 10.1007/s13187-015-0789-0
Comprehension of randomization is a vital, but understudied, component of informed consent to participate incancer randomized clinical trials(RCTs). Thisstudy examines patient comprehension of the randomization process as well as sources of ongoing uncertainty that may inhibit a patient’s ability to provide informed consent to participate in RCTs. Cancer patients living in rural Appalachia who were offeredanopportunitytoparticipateinacancertreatmentRCT completed in-depth interviews and a brief survey. No systematic differences in randomization comprehension between patients who consented and those who declined participation in a cancer RCT were detected. Comprehension is conceptually distinct from uncertainty, with patients who had both high and low comprehension experiencing randomization-related uncertainty. Uncertainty about randomization was found to have cognitive and affective dimensions. Not all patients enrolling in RCTs have a sufficient understanding of the randomization process to provide informed consent. Healthcare providers need to be aware of the different types of randomization-related uncertainty. Efforts to improve informed consent to participate in RCTs should focus on having patients teach back their understanding of randomization.This practice could yield valuable information about the patient’s cognitive and affective understanding of randomization as well as opportunities to correct misperceptions. Education about RCTs should reflect patient expectations of individualized care by explaining how all treatments being compared are appropriate to the specifics of a patient’s disease.
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