A Palliative Care Intervention for Patients on Phase 1 Studies

Area of Science:

• Oncology
• Palliative Care
• Clinical Trials

Background:

• Phase 1 clinical trials are crucial for cancer care, requiring supportive interventions for patients' quality of life.
• Patients in early-phase therapeutic trials often face significant psychological distress and symptom burden.

Purpose of the Study:

• To evaluate a Palliative Care Intervention (PCI) for patients with solid tumors in Phase 1 trials.
• To determine if PCI improves psychological distress, quality of life (QOL), satisfaction, symptoms, and resource utilization compared to usual care.

Main Methods:

• An unblinded, randomized trial comparing PCI with usual care.
• 479 adult patients with solid tumors initiating Phase 1 trials were followed for 24 weeks (12-week primary outcome).
• Outcomes included Psychological Distress (Distress Thermometer), QOL (FACT-G), satisfaction (FAM-CARE), survival, and resource utilization.

Main Results:

• PCI group showed significant improvements in Psychological Distress and Emotional Well-Being.
• Differences in QOL and distress varied between study sites.
• High symptom-management admissions (41.3%) and low Advance Directive completion (39.0%) and hospice enrollment (30.7%) were noted.

Conclusions:

• A nurse-delivered PCI can enhance QOL and reduce distress for patients in Phase 1 oncology trials.
• Increased integration of palliative care is essential for quality supportive care and end-of-life transitions in this population.