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

• Sponsor: City of Hope Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01612598
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 16
• Locations: 2
• Arm: 1
• Duration (Months): 18
• Patients Per Site: 8
• Patients Per Site Per Month: 0.4

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Unspecified Adult Solid Tumor, Protocol Specific	Other: counseling intervention; Procedure: quality-of-life assessment; Other: questionnaire administration; Other: educational intervention	N/A

Detailed Description

PRIMARY OBJECTIVES:

1. Describe the feasibility of implementing a PCI for patients on phase I clinical trials (study accrual and retention).

2. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Feasibility of a Palliative Care Intervention for Patients on Phase 1 Clinical Trials
• Study Start Date: Jul 1, 2012
• Actual Primary Completion Date: Jun 1, 2013
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm

Intervention/Treatment

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 Names: counseling and communications studies ; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment ; Other: questionnaire administration; Ancillary studies; Other: educational intervention; Undergo PCI; Other Names: intervention, educational

Outcome Measures

Primary Outcome Measures

1. Study accrual and retention [8 weeks]

2. 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.

3. 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.

4. 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.

5. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• 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

Locations

	Site	City	State	Country	Postal Code
1	City of Hope Medical Center	Duarte	California	United States	91010
2	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital	Baltimore	Maryland	United States	21231

Sponsors and Collaborators

• City of Hope Medical Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Betty Ferrell, City of Hope Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: City of Hope Medical Center
• ClinicalTrials.gov Identifier: NCT01612598
• Other Study ID Numbers: 12123; NCI-2012-00887
• First Posted: Jun 6, 2012
• Last Update Posted: Jan 31, 2014
• Last Verified: Jan 1, 2014

Study Results

No Results Posted as of Jan 31, 2014