A Palliative Care Intervention for Patients on Phase 1 Studies

Betty Ferrell, Vincent Chung, Mark T. Hughes, Marianna Koczywas, Nilofer Saba Azad, Nora H. Ruel, Louise Knight, Rhonda S. Cooper, Thomas J. Smith

Research output: Contribution to journalArticlepeer-review


Background: Phase 1 clinical trials remain vital for oncology care. Patients on these trials require supportive care for quality-of-life (QOL) concerns. Objective: 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. Design: This unblinded randomized trial compared the PCI with usual care in patients accrued to Phase I Clinical Trials. Subjects (n = 479) were followed for 24 weeks, with 12 weeks as the primary outcome. Setting: Two Comprehensive Cancer Centers in the United States. Subjects: A consecutive sample, 21 years or older, English fluency, with solid tumors initiating a Phase 1 trial. Measurements: Psychological Distress (Distress Thermometer), QOL total and subscales (FACT-G), satisfaction (FAM-CARE), survival, and resource utilization (chart audit). Results: PCI subjects showed improved Psychological Distress (-0.47, p = 0.015) and Emotional Well-Being (0.81, p = 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. Conclusions: 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.

Original languageEnglish (US)
Pages (from-to)846-856
Number of pages11
JournalJournal of palliative medicine
Issue number6
StatePublished - Jun 2021


  • palliative care
  • palliative care intervention
  • phase 1 clinical trials
  • quality of life

ASJC Scopus subject areas

  • General Nursing
  • Anesthesiology and Pain Medicine


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