Feasibility of a Palliative Care Intervention for Patients on Phase 1 Clinical Trials
I. Describe the feasibility of implementing a PCI for patients on phase I clinical trials
(study accrual and retention).
II. Describe the initial impact of a PCI on key patient outcome measures (quality of life
[QOL], psychological distress, satisfaction with communication, symptom intensity, symptom
distress, and patient satisfaction) over time.
PCI PART I: Patients undergo comprehensive palliative care (PC) assessment based on baseline
data and complete goals of care discussion.
PCI PART II: Following the first dose of phase I investigational treatment, patients meet
with the interdisciplinary team (IDT), where PC recommendations are made. This is followed
by two patient educational sessions that will cover QOL-related domains, including physical,
social, emotional, and spiritual well-being. Supportive care referrals are made based on IDT
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Study accrual and retention
City of Hope Medical Center
United States: Institutional Review Board
|City of Hope Medical Center||Duarte, California 91010|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital||Baltimore, Maryland 21231|