Quality of Life in Patients With Liver Cancer Treated With Image-Guided Therapy

June 3, 2015 updated by: Steven Meranze, Vanderbilt University

Outcomes Following Image-Guided Therapy for Hepatic Malignancies

RATIONALE: Gathering information about quality of life over time from patients with liver cancer treated with image-guided therapy may help the study of cancer in the future.

PURPOSE: This clinical trial is gathering information about quality of life over time from patients with liver cancer treated with image-guided therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Develop a data repository for clinical and health-related quality of life outcome measures in patients with hepatic malignancies treated with image-guided therapies.

OUTLINE: This is a pilot, prospective, longitudinal study.

Patients complete a standard questionnaire assessing health-related quality of life at baseline, during routine follow-up care after image-guided therapy, and then annually thereafter. Health and disease status and the development of other illnesses are assessed by medical record review.

PROJECTED ACCRUAL: Not specified

Study Type

Observational

Enrollment (Actual)

137

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center at Franklin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with hepatic neoplasms who undergo Image-guided Therapy

Description

DISEASE CHARACTERISTICS:

  • Undergoing concurrent image-guided therapy for hepatic malignancies using any of the following imaging techniques:

    • X-ray
    • Ultrasound
    • MRI
    • CT scan
    • Nuclear medicine imaging

PATIENT CHARACTERISTICS:

  • Not specified

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Image-guided Therapy
Patients undergoing Image-guided Therapy of Hepatic Neoplasms.
Other: medical chart review
Review the medical charts of patients with hepatic neoplasms who undergo Image-guided Therapy.
Other Names:
  • Embolization
  • Ablation
Other: questionnaire administration
Patients with hepatic neoplasms who undergo Image-guided Therapy
Other Names:
  • Embolization
  • Ablation
  • Chemo-embolization
Procedure: quality-of-life assessment
Patients with hepatic neoplasms who undergo Image-guided Therapy
Other Names:
  • Chemoembolization
  • Embolization
  • Ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of a data repository for clinical outcome measures by conducting a medical record review at baseline, during routine follow-up after image-guided therapy, and then annually thereafter
Time Frame: one year
one year
Development of a data repository for health-related quality of life outcome measures by administering the Medical Outcomes Study Short Form questionnaire at baseline, during routine follow-up after image-guided therapy, and then annually thereafter
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt University

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Steven G. Meranze, MD, Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

June 4, 2007

First Submitted That Met QC Criteria

June 4, 2007

First Posted (Estimate)

June 5, 2007

Study Record Updates

Last Update Posted (Estimate)

June 8, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000546520
  • P30CA068485 (U.S. NIH Grant/Contract)
  • VU-VICC-GI-0372 (Other Identifier: Vanderbilt University)
  • VU-VICC-IRB-020874 (Other Identifier: Vanderbilt University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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