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

This study is currently recruiting participants.
Verified August 2011 by Vanderbilt University
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00482586
First received: June 4, 2007
Last updated: August 8, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention
Liver Cancer
Metastatic Cancer
 Other: medical chart review
Other: questionnaire administration
Procedure: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Outcomes Following Image-Guided Therapy for Hepatic Malignancies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: October 2003
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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:
  • Ablation
  • Embolization
Other: questionnaire administration
Patients with hepatic neoplasms who undergo Image-guided Therapy
Other Names:
  • Ablation
  • Embolization
  • Chemo-embolization
Procedure: quality-of-life assessment
Patients with hepatic neoplasms who undergo Image-guided Therapy
Other Names:
  • Ablation
  • Embolization
  • Chemoembolization

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with hepatic neoplasms who undergo Image-guided Therapy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482586

Locations
United States, Tennessee
Vanderbilt-Ingram Cancer Center - Cool Springs Recruiting
Nashville, Tennessee, United States, 37064
Contact: Steven G Meranze     615-322-3906        
Vanderbilt-Ingram Cancer Center at Franklin Recruiting
Nashville, Tennessee, United States, 37064
Contact: Steven G Meranze     615-322-3906        
Vanderbilt-Ingram Cancer Center Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center     800-811-8480        
Sponsors and Collaborators
Vanderbilt University
National Cancer Institute (NCI)
Investigators
Study Chair: Steven G. Meranze, MD Vanderbilt-Ingram Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Steven G. Meranze, M.D., Vanderbilt University
ClinicalTrials.gov Identifier: NCT00482586     History of Changes
Other Study ID Numbers: CDR0000546520, P30CA068485, VU-VICC-GI-0372, VU-VICC-IRB-020874
Study First Received: June 4, 2007
Last Updated: August 8, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
adult primary liver cancer
liver metastases

Additional relevant MeSH terms:
Liver Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013