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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

June 4, 2012
January 29, 2014
July 2012
June 2013   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01612598 on ClinicalTrials.gov Archive Site
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Not Provided
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Palliative Care Intervention in Patients With Solid Tumors Participating in Phase I Clinical Trials
Feasibility of a Palliative Care Intervention for Patients on Phase 1 Clinical Trials

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

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Unspecified Adult Solid Tumor, Protocol Specific
  • 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
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.

Interventions:
  • Other: counseling intervention
  • Procedure: quality-of-life assessment
  • Other: questionnaire administration
  • Other: educational intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
January 2014
June 2013   (final data collection date for primary outcome measure)

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
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01612598
12123, NCI-2012-00887
Yes
City of Hope Medical Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Betty Ferrell City of Hope Medical Center
City of Hope Medical Center
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP