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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT01612598
First received: June 4, 2012
Last updated: January 29, 2014
Last verified: January 2014
  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

Resource links provided by NLM:


Further study details as provided by City of Hope Medical Center:

Primary Outcome Measures:
  • 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.


Enrollment: 16
Study Start Date: July 2012
Study Completion Date: January 2014
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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01612598

Locations
United States, California
City of Hope Medical Center
Duarte, California, United States, 91010
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
Sponsors and Collaborators
City of Hope Medical Center
Investigators
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: January 29, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on October 29, 2014