The informed consent statement is required to be read and signed by all patients participating in clinical trials. This document fulfills an important ethical and legal function, but also carries considerable potential as a valuable education tool. This potential is not fully realized in the majority of patients since the consent form is frequently difficult to read and comprehend. This multi-site randomized controlled study will be conducted to determine if utilization of an easy-to-read informed consent statement, when compared to a standard informed consent statement, will increase patient comprehension of the clinical trial treatment protocol, will decrease patient anxiety due to clinical trial involvement, and will increase patient accrual to the clinical treatment study. In order to investigate these objectives, the following specific aims will be accomplished: (1) The impact of using an easy-to-read informed consent statement on patient comprehension of two cancer treatment research protocols will be evaluated (E1594 - metastatic lung cancer; C9741 - adjuvant breast cancer). (2) The informed consent statements will be revised in both readability and layout, utilizing information obtained from a presently ongoing pilot study on informed consent. These easy-to- read informed consent statements will contain all the required information, yet be written in a manner that is easier for the patient to read and understand. (3) Member institutions of the participating cooperative groups implementing the treatment studies will be randomized to one of two arms: use of the standard informed consent statement or the easy-to-read consent statement. Patients being entered onto the selected treatment studies will receive one of the two consent statements, depending on the institutional assignment. (4) The impact of the easy-to-read consent statement will be assessed through the results of the telephone interviews to measure patient comprehension, satisfaction and anxiety, and by monitoring patient accrual. One of the major strengths of the proposed study is that it will be conducted within two established cooperative oncology groups (ECOG and NCCTG), thereby maximizing the external validity of the research. This study is designed to evaluate the impact of informed consent statements written in a language and presented in a format which can be standardized and readily applied to any clinical study being conducted locally, regionally or nationally.
| 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 |
