Assessing Psychological Toxicity and Patient-Reported Distress as the Sixth Vital Sign in Cancer Care and Clinical Trials.

As the number of available cancer therapies continues to grow, there is increasing interest in their impact on cancer patients' lived experiences. Screening for distress is one way to measure psychological dimensions of cancer patients' experiences, and doing so is increasingly part of standard operations at major cancer centers across the US. To date, however, most clinical trials have not adequately captured patients' experiences as part of their outcome assessments, so clinicians lack data needed to guide their responses to psychological features of patients' illness experiences. As distress becomes the "sixth vital sign" in routine cancer care, we argue that clinical trials should assess patients' experiences in the same way that they robustly screen for adverse events and toxicities. New interventions are needed to address distress.