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

City of Hope Medical Center16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

counseling interventionOTHER

Undergo PCI

quality-of-life assessmentPROCEDURE

Ancillary studies

questionnaire administrationOTHER

Ancillary studies

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (2)

City of Hope Medical Center

Duarte, California, United States

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

Study accrual and retention

Time frame: 8 weeks

Change in psychological distress assessed using Distress Thermometer

One-way repeated measure of Analysis of Covariance (ANCOVA), controlling for baseline scores and testing for within subjects change over time (4 weeks and 8 weeks) will be conducted to examine the PCI's impact on each of the outcome measures.

Time frame: Baseline to 8 weeks

Change in satisfaction with communication assessed using Satisfaction with Communication Tool

One-way repeated measure of ANCOVA, controlling for baseline scores and testing for within subjects change over time (4 weeks and 8 weeks) will be conducted to examine the PCI's impact on each of the outcome measures.

Time frame: Baseline to 8 weeks

Change in QOL using Functional Assessment of Cancer Therapy- General (FACT-G) and Functional Assessment of Chronic Illness Therapy- Spirituality (FACT-Sp-12)

Multivariate ANCOVAs (MANCOVAs) will be used at 4 and 8 weeks to examine the PCI's impact on QOL and symptom intensity and distress due to the multiple subscales in these two instruments.

Time frame: Baseline to 8 weeks

Change in symptom intensity and distress using Memorial Symptom Assessment Scale (MSAS)

MANCOVAs will be used at 4 and 8 weeks to examine the PCI's impact on QOL and symptom intensity and distress due to the multiple subscales in these two instruments.

Time frame: Baseline to 8 weeks

Data from ClinicalTrials.gov

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