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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Other: counseling intervention
* Procedure: quality-of-life assessment
* Other: questionnaire administration
* Other: educational intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (PCI)<br>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. | Other: counseling intervention<br>* Undergo PCI<br>* Other names: counseling and communications studies;Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;Other: questionnaire administration<br>* Ancillary studies<br>Other: educational intervention<br>* Undergo PCI<br>* Other names: intervention, educational;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study accrual and retention |  | 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. | 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. | 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. | 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. | Baseline to 8 weeks |