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

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

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.

Inclusion Criteria:

• Patients diagnosed with solid tumors who are being assessed for participation in phase I clinical trials of investigational cancer therapies
• Able to read or understand English
• Ability to read and/or understand the study protocol requirements, and provide written informed consent

Exclusion Criteria:

• Patient diagnosed with hematologic or brain cancers