Clinical trials of new treatments are a critical part of the medical research process. The process of telling patients about a trial, and asking whether they would agree to take part, is called informed consent. Researchers say, however, that informed consent for trials often causes patients to feel anxious and confused. Information about a trial can seem overwhelming: for instance, patients are asked to sign off on an information form that is often more than 15 pages long. This is a particular problem as clinical trial consent often needs to take place at a difficult time for patients, such as just after diagnosis or recurrence, when they are subject a host of new information and choices.
Researchers have documented that clinical trial consent causes clinically important increases in anxiety and, paradoxically, does not even result in a good understanding of trials: 70 percent of cancer trial participants are unaware that their treatment is experimental. Meanwhile, many trials are closed without including enough patients, at least in part because doctors may decline to approach patients for trial participation because getting informed consent is so difficult.
Recently, a new idea for consent has been proposed as a method to reduce patient anxiety and distress while maintaining patient autonomy. In two-stage consent, patients are asked to give consent for research (e.g. undergo an extra scan) and for the opportunity to be randomly selected for experimental treatment. Patients signing research consent are then randomized to a new treatment or to get usual medical care, with only those allocated to the experimental group participating in a second informed consent process. Patients allocated to the control group receive standard medical care as usual. Separating consent for research from consent for experimental treatment may reduce anxiety and distress associated with informed consent, particularly in the control group, who avoid hearing about the pros and cons of a treatment they will never receive.
Moreover, two-stage consent reduces the problem of information overload by breaking up information into more manageable chunks. In this grant, we propose to study two-stage consent. Patients at an academic cancer center who are approached for randomized trials of experimental treatment versus standard care will first be randomized to undergo standard one-stage versus two-stage consent. Patients will then be contacted shortly after the informed consent discussion and asked to about their experience (e.g. did the informed consent discussion make them anxious?) and their understanding of the trial (e.g. do they understand that the treatment they are receiving is experimental?). We will compare results between patients undergoing standard consent and those undergoing the new two-stage consent. We will also compare participation rates, that is, whether more patients approached for consent joint the trial if the consent is two-stage or one-stage. Finally, we will determine whether differences between groups depend on the type of trial, specifically whether stakes are low (e.g. a trial of a relaxation intervention to reduce pain during biopsy), or high (e.g. chemotherapy to improve survival).
*All proposed projects, including requested budgets and project periods, are approved subject to a programmatic and budget review by PCORI staff and the negotiation of a formal award contract.