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

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.

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Key information

Conditions

Liver Cancer Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Metastatic Cancer Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Official study 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)

Important dates

Study start: 2008
Primary completion: 2010
Study completion: 2010
First posted: Aug 21, 2008
Registry last updated: Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed