Are we undermining the value of palliative care through advanced cancer clinical trial consent language?

Abstract

We believe that this framing undermines the many advances in palliative care over the past 3 decades, sends unintended messages, and is a disservice to the patients and families that we serve. We found language offering variations of comfort care or palliative care as an alternative to trial participation in both pediatric and adult oncology consent forms across multiple institutions and clinical trials. This language appears to be unique to informed consents in oncology, as these terms were not included as alternatives in consents across other disease groups. The incorporation of palliative care into the informed consent form as an alternative to trial participation stems from templated language from regulatory bodies, including the National Cancer Institute. Although the breadth of symptom support described is accurate, labeling the nontreatment path in this way misrepresents palliative care. These required and templated forms equate palliative care to comfort care, a phrase that is nebulous and poorly defined, and propagate language that lacks clarity about the types of care that patients and families may want to prioritize and/or avoid. Informed consent forms are required in clinical research to communicate the purpose of the study, risks and benefits of participation, and treatment alternatives. Informed consent is a process and includes both written documentation and conversations between providers and patients. The disclosure of alternative treatments during this process is a federal legal and regulatory requirement. However, the inclusion of palliative care among the listed alternatives to participation in an advanced cancer clinical trial is problematic. As described by the World Health Organization, palliative care aims to improve the quality of life for seriously ill patients and families and is applicable early in the course of illness in conjunction with lifeprolonging therapies. Palliative care is an approach to care; models have been created to distinguish primary palliative care, which includes communication and symptom management skills, from specialty palliative care, which encompasses advanced skills and training in symptom management, complex psychosocial issues, and communication. Although informed consents for advanced cancer trials may be an appropriate time to introduce palliative care, we believe that doing so in this manner raises 2 key issues. First, presenting palliative care as an alternative to cancerdirected therapy suggests that the two cannot occur simultaneously: patients and families must choose to treat their cancer or choose to be comfortable. Second, informed consents may be a patient or family’s first introduction to palliative care, and equating it to comfort care in this setting suggests that palliative care is equivalent to endoflife care and perpetuates misperceptions that hinder early palliative care uptake. The benefits of early integration of palliative care within oncology have been well described. Patients receiving palliative care concurrently with cancerdirected therapy have better symptom control, quality of life, and satisfaction with care, less psychological distress, and may experience survival benefits in comparison with those receiving cancerdirected treatment alone. The integration of palliative care and oncology care is particularly important in pediatrics, where patients and families often have blended goals throughout their illness trajectory. Patients may mistakenly perceive early phase trials to be in opposition to palliative care, and both patients and oncologists may not recognize the complementary nature of palliative care and diseasefocused therapy. For some individuals, the involvement of palliative care while