An Intervention to Improve Cancer Patients' Understanding of Early-Phase Clinical Trials
Kass, Nancy E., Sugarman, Jeremy, Medley, Amy M., Fogarty, Linda A., Taylor, Holly A., Daugherty, Christopher K., Emerson, Mark R., Goodman, Steven N., Hlubocky, Fay J., Hurwitz, Herbert I., Carducci, Michael, Goodwin-Landher, Annallys, IRB: Ethics & Human Research
The consent process for human subjects research educates potential participants about research risks, benefits, and procedures so they can make an informed decision about whether to enroll in a clinical trial. Yet numerous studies demonstrate that trial participants sometimes have difficulty distinguishing research from clinical care--i.e., they believe the experimental innovation is therapy. (1) This "therapeutic misconception" is widespread, (2) including among research participants in oncology clinical trials. For instance, Joffe and colleagues found that 30% of oncology trial participants believed that the investigational therapy was proven to be the best treatment for their cancer. (3) In another study, Daugherty et al. found that 73% of 144 participants in a phase I trial joined the study seeking an "anticancer response" including cure or remission, and 61% reported the main purpose of the trial was to determine efficacy. (4) In a study we conducted, 17% of cancer patients recruited for phase I trials believed the trials promised a cure, 60% reported a purpose related to efficacy, and only 17% mentioned a purpose related to dosing, safety, or side effects. (5) If these reports regarding participants' beliefs about clinical trials reflect a true misconception that investigational interventions are actually proven treatments, this is ethically troubling, particularly for early phase clinical trials where the primary purpose is to determine toxicity and dosing rather than efficacy.
Our own work has further documented that oncologists often couple discouraging statements about research benefit with longer encouraging ones. They also sometimes emphasize the chance of a great breakthrough and suggest that the decision regarding trial enrollment depends on whether the patient likes to "play the lottery," or wants to "try for the home run." (6) Yet other studies have shown that phase I oncology consent forms do not overestimate the benefit of early phase clinical trials. (7) Such work, when taken together, suggests that consent interventions may be useful as a means of providing supplemental or more detailed information to patients being recruited to participate in these types of trials.
Traditionally, however, most empirical research testing different interventions to improve individuals' understanding of clinical research (8) has been conducted in simulated research and treatment settings, rather than in actual clinical trials. Studies have measured the effects of simplifying consent forms (9) and/or of giving quizzes with "corrected feedback" (10) for respondents imagining hypothetical studies. Some intervention studies showed an increase in understanding. Two studies gave oncology patients a simplified consent form for actual trials, though neither found that the patients' level of understanding differed from that achieved through the consent process that used a standard consent form. (11)
Multimedia interventions have also been tested to see whether they improve patients' understanding of a clinical trial, with mixed results. (12) Participants who were shown a video about a hypothetical clinical trial, quizzed about what they learned from it, and then provided corrected feedback understood more than control subjects. (13) Other studies, however, have found that an interactive computer tool did not increase oncology patients' understanding of a hypothetical trial. (14) Cancer patients randomized to a video or computer instructional program did not improve their understanding when compared to patients using a standard consent process. (15) Studies supplementing standard consent with videos have also shown an increase in understanding too small to be significant. (16)
One criticism of multimedia interventions is that they repackage the same information provided in traditional consent documents. It might be more important, then, to test how different information is given to prospective subjects. …