Unspecified Adult Solid Tumor, Protocol Specific
Conditions
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.
Interventions
OTHERcounseling intervention
Undergo PCI
PROCEDUREquality-of-life assessment
Ancillary studies
OTHERquestionnaire administration
Ancillary studies
OTHEReducational intervention
Undergo PCI
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed