Quality of Life in Patients Undergoing Embolization Using Yttrium Y 90 Glass Microspheres for Primary or Metastatic Liver Cancer
Overview
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.
Full Title of Study: “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)”
Study Type
- Study Type: Observational
- Study Design
- Time Perspective: Prospective
- Study Primary Completion Date: May 2010
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.
Arms, Groups and 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.
Clinical Trial Outcome Measures
Primary Measures
- Quality of life of all patients over the course of treatment
- Time Frame: Before treatment, 2 weeks post, and 1 month post
- Quality of life differences between treatment groups
- Time Frame: Before treatment, 2 weeks post, and 1 month post
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Northwestern University
- Collaborator
- National Cancer Institute (NCI)
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Peggy Gilbertsen, RN, BS, Principal Investigator, Robert H. Lurie Cancer Center
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