Clinical trial NCT00739167: Quality of Life in Patients Undergoing Embolization Using Yttrium Y 90 Glass Microspheres for Primary or Metastatic Liver Cancer
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cancer
Metastatic Cancer
Keywords: adult primary hepatocellular carcinoma
advanced adult primary liver cancer
liver metastases
recurrent adult primary liver cancer
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-08-21
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of hepatocellular carcinoma being treated with either TACE, RFA, or Y90.

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.

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

Primary outcomes:
measure: Quality of life of all patients over the course of treatment
timeFrame: Before treatment, 2 weeks post, and 1 month post
measure: Quality of life differences between treatment groups
timeFrame: Before treatment, 2 weeks post, and 1 month post
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Robert H. Lurie Comprehensive Cancer Center at Northwestern University
state: Illinois
Study officials:
affiliation: Robert H. Lurie Cancer Center
name: Peggy Gilbertsen, RN, BS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Salem R, Gilbertsen M, Butt Z, Memon K, Vouche M, Hickey R, Baker T, Abecassis MM, Atassi R, Riaz A, Cella D, Burns JL, Ganger D, Benson AB 3rd, Mulcahy MF, Kulik L, Lewandowski R. Increased quality of life among hepatocellular carcinoma patients treated with radioembolization, compared with chemoembolization. Clin Gastroenterol Hepatol. 2013 Oct;11(10):1358-1365.e1. doi: 10.1016/j.cgh.2013.04.028. Epub 2013 May 2.