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Integration of Palliative Care for Cancer Patients on Phase I Trials


N/A
21 Years
N/A
Not Enrolling
Both
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

Integration of Palliative Care for Cancer Patients on Phase I Trials


PRIMARY OBJECTIVES:

I. Test the effects of a palliative care intervention (PCI) on patients' quality of life
(QOL), psychological distress and satisfaction with communication, comparing the
experimental versus control groups.

II. Test the effects of a PCI on patients' symptom intensity and symptom interference with
daily activities, comparing the experimental versus control groups.

III. Test the effects of a PCI on patients' hospital and palliative care resource
utilization and clinical trial retention rates, comparing the experimental versus control
groups.

IV. Test the effects of the timing of PCI initiation (early versus delayed) on patient
outcomes, comparing the experimental versus control groups.

V. Describe patients' satisfaction with the PCI.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive part I of the PCI comprising quantitative surveys, comprehensive
palliative care assessment by the Research Nurses, and goals of care discussions beginning
prior to administration of the first dose of phase I treatment. Patients then receive part
II of the PCI comprising recommendations from the interdisciplinary team, patent educational
sessions, and supportive care referrals following the first dose of phase I treatment and is
completed within one month of the first treatment.

ARM II: Patients receive usual care until 12 weeks post-treatment initiation. Patients then
receive both part I and II of the PCI.

After completion of study, patients are followed up for 5 years.


Inclusion Criteria:



- Patients diagnosed with solid tumors who are eligible for participation in Phase I
clinical trials of investigational cancer therapies

- Patients who have signed an informed consent for participation in Phase I clinical
trials

- Able to read or understand English-this is included because the intervention and
study materials (including outcome measures) are only in English

- Ability to read and/or understand the study protocol requirements, and provide
written informed consent

Exclusion Criteria:

- Patients diagnosed with hematologic (as a population distinct from solid tumors and
different trials) or brain cancers (due to cognitive ability)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Change in overall QOL scores, assessed by the Functional Assessment of Cancer Therapy-General (FACT-G) and Functional Assessment of Chronic Illness Therapy-Spirituality (FACIT-Sp)

Outcome Description:

To control for inflation of experimentwise error caused by analyzing four different QOL subscales, alpha will be set to .01. A 2x2 multiply repeated measures ANCOVA (in which the within groups variables are QOL subscale scores at 4 and 12 weeks, the between groups measure is treatment group (control vs. PCI), and the covariate is baseline QOL) might be employed if the correlation between the four FACT-G subscale scores are high enough to warrant such an analysis. The overall QOL score derived from the FACT-G will be tested individually using alpha=.05. If subscale correlations are not high, outcome will be analyzed using four 2x2 repeated measures ANCOVAs in which the within groups variable is each QOL subscale, the between groups measure is group (PCI vs. control), and the covariate is the appropriate baseline QOL subscale (Physical well-being, emotional well-being, social well-being, and functional well-being).

Outcome Time Frame:

Baseline to 12 weeks

Safety Issue:

No

Principal Investigator

Betty Ferrell

Investigator Role:

Principal Investigator

Investigator Affiliation:

City of Hope Medical Center

Authority:

United States: Federal Government

Study ID:

13193

NCT ID:

NCT01828775

Start Date:

September 2013

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific

Name

Location

Sidney Kimmel Cancer CenterSan Diego, California  92121
City of Hope Medical CenterDuarte, California  91010