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

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)

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00739167

Enrollment

Registered

2008-08-21

Start date

2008-04-30

Completion date

2010-05-31

Last updated

2015-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cancer, Metastatic Cancer

Keywords

adult primary hepatocellular carcinoma, advanced adult primary liver cancer, liver metastases, recurrent adult primary liver cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Countries

United States

Outcome results