TY - JOUR
T1 - A Palliative Care Intervention for Patients on Phase 1 Studies
AU - Ferrell, Betty
AU - Chung, Vincent
AU - Hughes, Mark T.
AU - Koczywas, Marianna
AU - Azad, Nilofer Saba
AU - Ruel, Nora H.
AU - Knight, Louise
AU - Cooper, Rhonda S.
AU - Smith, Thomas J.
N1 - Publisher Copyright:
© 2021 Mary Ann Liebert Inc.. All rights reserved.
PY - 2021/6
Y1 - 2021/6
N2 - 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.
AB - 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.
KW - palliative care
KW - palliative care intervention
KW - phase 1 clinical trials
KW - quality of life
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U2 - 10.1089/jpm.2020.0597
DO - 10.1089/jpm.2020.0597
M3 - Article
C2 - 33103938
AN - SCOPUS:85104391211
SN - 1096-6218
VL - 24
SP - 846
EP - 856
JO - Journal of palliative medicine
JF - Journal of palliative medicine
IS - 6
ER -