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A Quality of Life Study for Patients With Primary or Metastatic Liver Cancer Who Are Treated With Radioembolization (Y90 Microspheres) or Transcatheter Arterial Embolization (TACE)


N/A
18 Years
N/A
Not Enrolling
Both
Liver Cancer, Metastatic Cancer

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Trial Information

A Quality of Life Study for Patients With Primary or Metastatic Liver Cancer Who Are Treated With Radioembolization (Y90 Microspheres) or Transcatheter Arterial Embolization (TACE)


OBJECTIVES:

Primary

- Assess the quality of life (QOL) as defined by the presence or absence of physical,
social, emotional, and functional distress in patients with primary or metastatic liver
cancer undergoing treatment with radioembolization or transcatheter arterial
embolization.

- Compare the time course of QOL measures between treatment groups in patients treated
with these regimens.

- Compare the time course of QOL measures between patient subgroups defined by
pre-treatment quality of life or tumor burden.

OUTLINE: Patients complete FACT-Hep version 4 surveys on quality of life prior to initiation
of embolization, and at 2 weeks and 1 month after completion of embolization.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of primary hepatocellular cancer or metastatic liver cancer

- Planning radioembolization or transcatheter arterial embolization using yttrium Y 90
glass microspheres

- No encephalopathy

PATIENT CHARACTERISTICS:

- ECOG performance status 0-2

- Bilirubin ≤ 3 mg/dL

- Able to comply with study procedures

PRIOR CONCURRENT THERAPY:

- No prior treatment with radioembolization or transcatheter arterial embolization

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Quality of life of all patients over the course of treatment

Outcome Time Frame:

Before treatment, 2 weeks post, and 1 month post

Safety Issue:

No

Principal Investigator

Peggy Gilbertsen, RN, BS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Robert H. Lurie Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

NU 07Q1

NCT ID:

NCT00739167

Start Date:

April 2008

Completion Date:

May 2010

Related Keywords:

  • Liver Cancer
  • Metastatic Cancer
  • adult primary hepatocellular carcinoma
  • advanced adult primary liver cancer
  • liver metastases
  • recurrent adult primary liver cancer
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary

Name

Location

Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611