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Feasibility of a Palliative Care Intervention for Patients on Phase 1 Clinical Trials


N/A
21 Years
N/A
Open (Enrolling)
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Feasibility of a Palliative Care Intervention for Patients on Phase 1 Clinical Trials


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Study accrual and retention

Outcome Time Frame:

8 weeks

Safety Issue:

No

Principal Investigator

Betty Ferrell

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Institutional Review Board

Study ID:

12123

NCT ID:

NCT01612598

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific

Name

Location
City of Hope Medical Center Duarte, California  91010
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital Baltimore, Maryland  21231