Simultaneous care: a model approach to the perceived conflict between investigational therapy and palliative care

Abstract

Clinical trials of investigational therapy in patients with advanced cancer may not pay sufficient attention to quality of life (QOL) and supportive care issues, resulting in an adverse impact on the quality of care (QOC). We hypothesized that the simultaneous delivery of investigational therapy and a structured program of supportive care would result in measurable improvements in predefined outcomes without adverse events for patients, caregivers, or the physician/patient interaction. This report describes the findings of a trial designed to test the feasibility and initial results of such an approach. Forty-four patients accrued to Phase I or Phase II investigational therapy trials were simultaneously enrolled into a defined home care program focused on supportive care needs of the patient and family, as well as assessment of the toxicities of investigational therapy. These 44 patients constitute the Simultaneous Care (SC) cohort. Twenty patients receiving investigational therapy and the standard supportive care measures available through the Cancer Center served as a control group, designated the Usual Care (UC) cohort. We measured QOL using baseline and monthly assessments of the Functional Assessment of Cancer Therapy (FACT-G) instrument. This instrument measures four domains of well-being: physical, emotional, functional, and social/family. We prospectively defined QOC as: the percentage of hospice referrals; hospice length of stay; and number of cycles of chemotherapy administered. A summary score for the four FACT domains at each time point for each patient was calculated (FACT 4). The FACT 4 scores of the SC group improved compared to the UC group but did not reach a significant difference. Individual scores reflected a wide range of psychometric variability. A statistically significant difference in referral to hospice was seen in the SC group (35/44) compared to the UC group (8/15) (P=0.034). The median length of stay in hospice was the same for both cohorts but the mean stay was greater in the SC cohort (54 days) compared to the UC cohort (37 days). The mean number of chemotherapy cycles was not different between SC and UC (P=0.25). The self-reported acceptance by patients, caregivers, physicians and Cancer Center support staff was qualitatively excellent. Patients with advanced cancer at the time of enrollment onto investigational therapy should have made an explicit transition to palliative care goals but often have not. In the current health care environment, patients with advanced cancer without curative potential may be forced by their health provider or health insurer to choose between disease-directed therapy (including investigational therapy) or structured best supportive care programs. In this emerging era of targeted therapies, SC provides an approach designed to optimize palliative care goals while supporting the clinical research mission of offering patients with advanced cancer new and potentially better therapeutic interventions. SC is a system of care that enhances patient choice by allowing patients and families to have concurrent access to two beneficial options. SC may enhance coordination of care and facilitate patients' explicit transition from curative intent to palliative intent. In order to validate this approach, a randomized comparative trial evaluating SC has been initiated.