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

Study Overview
=================
Brief Summary
-----------------
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.

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.

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)

Conditions
-----------------
Liver Cancer, Metastatic Cancer

Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Y90 Group<br>Patients receiving treatment with radioembolization. | |
| TACE Group<br>Patients receiving treatment with transcatheter arterial embolization | |
| RFA Group<br>Patients receiving treatment with radiofrequency ablation. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life of all patients over the course of treatment |  | Before treatment, 2 weeks post, and 1 month post | 
| Quality of life differences between treatment groups |  | Before treatment, 2 weeks post, and 1 month post | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult primary hepatocellular carcinoma, advanced adult primary liver cancer, liver metastases, recurrent adult primary liver cancer