Improving Informed Consent for Palliative Chemotherapy

Research indicates that many patients with advanced cancer receive palliative chemotherapy without sufficient understanding of its likely risks and benefits. In surveys, many patients receive palliative chemotherapy without expressing an understanding that cure is unlikely. The root of this problem is undoubtedly complex, but may relate to gaps in communication and patient education about the risks and benefits of treatment. Patients are routinely asked to sign an "informed consent" document prior to starting chemotherapy, indicating they understand the risks and benefits of treatment. Although this could be a strategic moment to equip patients with information they need to make truly informed medical decisions, many patients and caregivers note that these conversations are less useful than they could be. The informed consent process and its associated documents suffer several limitations: 1) risks are emphasized over benefits; 2) educational materials focus on individual drugs instead of regimens; 3) information is presented in written instead of alternative written/audiovisual format; and 4) the patient perspective is lacking. The overarching objective of this trial is to test a suite of patient-centered videos and booklets to support informed consent for common chemotherapy regimens used to treat advanced gastrointestinal cancers. In this study, patients with metastatic colorectal cancer, locally advanced and metastatic pancreatic cancer considering treatment with first or second-line palliative chemotherapy were randomized to the usual process of chemotherapy informed consent, or usual care supplemented by access to the appropriate investigational chemotherapy informed consent video and booklet. Patients were surveyed at baseline, 2-weeks post-treatment initiation, and 3 months regarding their understanding of chemotherapy risks and benefits, decisional conflict, and other metrics of informed decision-making.