Palliative Care Intervention in Patients With Solid Tumors Participating in Phase I Clinical Trials
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Purpose
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
| Condition | Intervention |
|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Other: counseling intervention Procedure: quality-of-life assessment Other: questionnaire administration Other: educational intervention |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Feasibility of a Palliative Care Intervention for Patients on Phase 1 Clinical Trials |
- Study accrual and retention [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Change in psychological distress assessed using Distress Thermometer [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]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) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]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) [ Time Frame: Baseline to 8 weeks ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2012 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Supportive Care (PCI)
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
Undergo PCI
Other Name: counseling and communications studies
Procedure: quality-of-life assessment
Ancillary studies
Other Name: quality of life assessment
Other: questionnaire administration
Ancillary studies
Other: educational intervention
Undergo PCI
Other Name: intervention, educational
|
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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| United States, California | |
| City of Hope Medical Center | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Betty Ferrell 800-826-4673 bferrell@coh.org | |
| Principal Investigator: Betty Ferrell | |
| United States, Maryland | |
| Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital | Recruiting |
| Baltimore, Maryland, United States, 21231 | |
| Contact: Thomas Smith, MD 410-955-2091 | |
| Principal Investigator: Thomas Smith, MD | |
| Principal Investigator: | Betty Ferrell | City of Hope Medical Center |
More Information
No publications provided
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT01612598 History of Changes |
| Other Study ID Numbers: | 12123, NCI-2012-00887 |
| Study First Received: | June 4, 2012 |
| Last Updated: | February 15, 2013 |
| Health Authority: | United States: Institutional Review Board |
ClinicalTrials.gov processed this record on May 19, 2013