A Palliative Care Intervention for Patients on Phase 1 Studies.

Abstract

<b><i>Background:</i></b> Phase 1 clinical trials remain vital for oncology care. Patients on these trials require supportive care for quality-of-life (QOL) concerns. <b><i>Objective:</i></b> To test a Palliative Care Intervention (PCI) for patients with solid tumors enrolled in Phase I therapeutic trials with a priori hypothesis that psychological distress, QOL, satisfaction, symptoms, and resource utilization would be improved in the PCI group. <b><i>Design:</i></b> This unblinded randomized trial compared the PCI with usual care in patients accrued to Phase I Clinical Trials. Subjects (<i>n</i> = 479) were followed for 24 weeks, with 12 weeks as the primary outcome. <b><i>Setting:</i></b> Two Comprehensive Cancer Centers in the United States. <b><i>Subjects:</i></b> A consecutive sample, 21 years or older, English fluency, with solid tumors initiating a Phase 1 trial. <b><i>Measurements:</i></b> Psychological Distress (Distress Thermometer), QOL total and subscales (FACT-G), satisfaction (FAM-CARE), survival, and resource utilization (chart audit). <b><i>Results:</i></b> PCI subjects showed improved Psychological Distress (-0.47, <i>p</i> = 0.015) and Emotional Well-Being (0.81, <i>p</i> = 0.045), with differences on variables of QOL and distress between sites. High rates of symptom-management admissions (41.3%) and low rates of Advance Directive completion (39.0%), and hospice enrollment (30.7%), despite a median survival in both groups of 10.1 months from initiating a Phase 1 study. <b><i>Conclusions:</i></b> A nurse-delivered PCI can improve some QOL outcomes and distress for patients participating in Phase 1 trials. Greater integration of PC is needed to provide quality care to these patients and to support transitions from treatment to supportive care, especially at the end of life. ClinicalTrials.gov Identifier: NCT01612598.