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

Abstract

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.

Strategies to Understand What Matters to Advanced Cancer Patients in Advance Care Planning: A Qualitative Study Using the Lifeline Interview Method

“…The qualitative descriptive exploratory design was used to describe the perspectives of study participants experiencing a phenomenon of interest 19 . This design allows detailed descriptions of an experienced phenomenon, offering a unique opportunity to gain insight into “emic knowledge” and learn how those involved see their world 19 . The Standards for Reporting Qualitative Research approach was followed to ensure rigor in reporting.…”

“…In addition, a prognosis of less than 1 year suggests the relevance of initiating ACP discussions 14,21 . Data collection was discontinued once it was confirmed that no new codes emerged from the interviews 19 …”

Non-pharmacological interventions to manage psychological distress in patients living with cancer: a systematic review

“…The National Comprehensive Cancer Network (NCCN), in their recently revised guidance, define distress in cancer as ‘….a multifactorial unpleasant experience of a psychological (i.e., cognitive, behavioral, emotional), social, spiritual, and/or physical nature that may interfere with one’s ability to cope effectively with cancer, its physical symptoms, and its treatment’ [ 2 ]. The American Medical Association (AMA) characterises psychological distress as an inability to cope with the disease or its treatment, a lack of control and a condition distinct from anxiety and depression [ 3 ]. Distress has been proposed as the 6 th vital sign in cancer care by the International Psycho-Oncology Society [ 4 , 5 ] and the AMA recommend that screening for, and treating, distress should become an integral part of care plans.…”

Coping Style, Insomnia, and Psychological Distress Among Persons With Gastrointestinal Cancer

“…In particular, there is a growing awareness that psychological distress is associated with increased physical symptoms and decreased quality of life and can also be a barrier for patients to engage in survivorship care (Cha et al, 2017). The International Psycho-Oncology Society has listed psychological distress as the sixth vital sign and a routine item in clinical nursing practice (LeBlanc & Kamal, 2017); the need for psychological status evaluation and management of these patients should be emphasized.…”