Palliative Care Intervention in Patients With Solid Tumors Participating in Phase I Clinical Trials
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- Other: counseling interventionProcedure: quality-of-life assessmentOther: questionnaire administrationOther: educational intervention
- Registration Number
- NCT01612598
- Lead Sponsor
- City of Hope Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- Patient diagnosed with hematologic or brain cancers
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Supportive Care (PCI) counseling intervention 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. Supportive Care (PCI) quality-of-life assessment 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. Supportive Care (PCI) questionnaire administration 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. Supportive Care (PCI) educational intervention 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.
- Primary Outcome Measures
Name Time Method Study accrual and retention 8 weeks Change in psychological distress assessed using Distress Thermometer Baseline to 8 weeks 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.
Change in satisfaction with communication assessed using Satisfaction with Communication Tool Baseline to 8 weeks 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.
Change in QOL using Functional Assessment of Cancer Therapy- General (FACT-G) and Functional Assessment of Chronic Illness Therapy- Spirituality (FACT-Sp-12) Baseline to 8 weeks 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.
Change in symptom intensity and distress using Memorial Symptom Assessment Scale (MSAS) Baseline to 8 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
City of Hope Medical Center
🇺🇸Duarte, California, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
🇺🇸Baltimore, Maryland, United States