Integration of Palliative Care for Cancer Patients on Phase I Trials
I. Test the effects of a palliative care intervention (PCI) on patients' quality of life
(QOL), psychological distress and satisfaction with communication, comparing the
experimental versus control groups.
II. Test the effects of a PCI on patients' symptom intensity and symptom interference with
daily activities, comparing the experimental versus control groups.
III. Test the effects of a PCI on patients' hospital and palliative care resource
utilization and clinical trial retention rates, comparing the experimental versus control
IV. Test the effects of the timing of PCI initiation (early versus delayed) on patient
outcomes, comparing the experimental versus control groups.
V. Describe patients' satisfaction with the PCI.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive part I of the PCI comprising quantitative surveys, comprehensive
palliative care assessment by the Research Nurses, and goals of care discussions beginning
prior to administration of the first dose of phase I treatment. Patients then receive part
II of the PCI comprising recommendations from the interdisciplinary team, patent educational
sessions, and supportive care referrals following the first dose of phase I treatment and is
completed within one month of the first treatment.
ARM II: Patients receive usual care until 12 weeks post-treatment initiation. Patients then
receive both part I and II of the PCI.
After completion of study, patients are followed up for 5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Change in overall QOL scores, assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) and Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp)
To control for inflation of experimentwise error caused by analyzing four different QOL subscales, alpha will be set to .01. A 2x2 multiply repeated measures ANCOVA (in which the within groups variables are QOL subscale scores at 4 and 12 weeks, the between groups measure is treatment group (control vs. PCI), and the covariate is baseline QOL) might be employed if the correlation between the four FACT-G subscale scores are high enough to warrant such an analysis. The overall QOL score derived from the FACT-G will be tested individually using alpha=.05. If subscale correlations are not high, outcome will be analyzed using four 2x2 repeated measures ANCOVAs in which the within groups variable is each QOL subscale, the between groups measure is group (PCI vs. control), and the covariate is the appropriate baseline QOL subscale (Physical well-being, emotional well-being, social well-being, and functional well-being).
Baseline to 12 weeks
City of Hope Medical Center
United States: Federal Government
|Sidney Kimmel Cancer Center||San Diego, California 92121|
|City of Hope Medical Center||Duarte, California 91010|