Quality of Life in Patients Undergoing Embolization Using Yttrium Y 90 Glass Microspheres for Primary or Metastatic Liver Cancer

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Northwestern University
ClinicalTrials.gov Identifier:
NCT00739167
First received: August 20, 2008
Last updated: April 6, 2011
Last verified: April 2011
  Purpose

RATIONALE: Learning about quality of life in patients with cancer undergoing embolization may help doctors learn about the side effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying quality of life in patients undergoing embolization using yttrium Y 90 glass microspheres for primary or metastatic liver cancer.


Condition
Liver Cancer
Metastatic Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • Quality of life of all patients over the course of treatment [ Time Frame: Before treatment, 2 weeks post, and 1 month post ] [ Designated as safety issue: No ]
  • Quality of life differences between treatment groups [ Time Frame: Before treatment, 2 weeks post, and 1 month post ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: April 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Y90 Group
Patients receiving treatment with radioembolization.
TACE Group
Patients receiving treatment with transcatheter arterial embolization
RFA Group
Patients receiving treatment with radiofrequency ablation.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a diagnosis of hepatocellular carcinoma being treated with either TACE, RFA, or Y90.

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
  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: NCT00739167

Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Peggy Gilbertsen, RN, BS Robert H. Lurie Cancer Center
  More Information

Additional Information:
No publications provided by Northwestern University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Margaret Gilbertsen, Northwestern University
ClinicalTrials.gov Identifier: NCT00739167     History of Changes
Other Study ID Numbers: NU 07Q1, P30CA060553, NU-07Q1, NU-IRB-STU00002799
Study First Received: August 20, 2008
Last Updated: April 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
adult primary hepatocellular carcinoma
advanced adult primary liver cancer
liver metastases
recurrent adult primary liver cancer

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on July 29, 2014