Spots Global Cancer Trial Database for Palliative Care Intervention in Patients With Solid Tumors Participating in Phase I Clinical Trials

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Trial Identification

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

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

Study ID: NCT01612598

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Interventions

counseling intervention

quality-of-life assessment

questionnaire administration

educational intervention

Study Description

Brief Summary: 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: 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.