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

City of Hope

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Other: questionnaire administration; Procedure: quality-of-life assessment; Other: counseling intervention; Other: educational intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01612598

12123

NCI-2012-00887 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 16 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Supportive Care (PCI)

Experimental group

Description:

PCI PART I: Patients undergo comprehensive 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 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.

Treatment:

Other: educational intervention

Other: counseling intervention

Procedure: quality-of-life assessment

Other: questionnaire administration