NCT01612598

Palliative Care Intervention in Patients With Solid Tumors Participating in Phase I Clinical Trials

Feasibility of a Palliative Care Intervention for Patients on Phase 1 Clinical Trials

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: City of Hope Medical Center · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

Patients enrolled in phase I clinical trials could potentially benefit from palliative care concurrently, yet limited evidence is available to support such a change in care. The primary purpose of this study is to test the feasibility of a palliative care intervention (PCI) for patients participating in a phase I therapeutic clinical trial

Detailed description

PRIMARY OBJECTIVES: 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. OUTLINE: 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 recommendations.

Conditions

• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	counseling intervention	Undergo PCI
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	questionnaire administration	Ancillary studies
OTHER	educational intervention	Undergo PCI

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-06-01
• Completion: 2014-01-01
• First posted: 2012-06-06
• Last updated: 2014-01-31

Locations

2 sites across 1 country: United States