NCT01828775

Palliative Care Intervention in Improving Quality of Life, Psychological Distress, and Communication in Patients With Solid Tumors Receiving Treatment

Integration of Palliative Care for Cancer Patients on Phase I Trials

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 480 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

This pilot randomized clinical trial studies palliative care intervention in improving quality of life, psychological distress, and communication in patients with solid tumors receiving treatment on phase I trials. Cancer patients experience many symptoms related to treatment and the cancer itself that can be distressing and impact quality of life. Palliative care focuses on managing these symptoms and may help patients with solid tumors live more comfortably.

Detailed description

PRIMARY OBJECTIVES: 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 groups. 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, patient 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.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	palliative care	Receive early PCI
OTHER	palliative care	Receive delayed PCI
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	survey administration	Ancillary studies

Timeline

• Start date: 2014-09-08
• Primary completion: 2020-05-18
• Completion: 2020-05-18
• First posted: 2013-04-11
• Last updated: 2021-03-10

Locations

2 sites across 1 country: United States