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

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