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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Vanderbilt University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Steven Meranze, Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00482586
First received: June 4, 2007
Last updated: May 28, 2014
Last verified: May 2014

June 4, 2007
May 28, 2014
October 2003
October 2016   (final data collection date for primary outcome measure)
  • 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 ]
  • Data repository for clinical outcome measures assessed by medical record review at baseline, during routine follow-up after image-guided therapy, and then yearly
  • Data repository for health-related quality of life outcome measures assessed by the Medical Outcomes Study Short Form at baseline, during routine follow-up after image-guided therapy, and then yearly
Complete list of historical versions of study NCT00482586 on ClinicalTrials.gov Archive Site
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Quality of Life in Patients With Liver Cancer Treated With Image-Guided Therapy
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.

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

Observational
Observational Model: Case Control
Time Perspective: Retrospective
Not Provided
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Non-Probability Sample

Patients with hepatic neoplasms who undergo Image-guided Therapy

  • Liver Cancer
  • Metastatic Cancer
  • 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
Image-guided Therapy
Patients undergoing Image-guided Therapy of Hepatic Neoplasms.
Interventions:
  • Other: medical chart review
  • Other: questionnaire administration
  • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
Not Provided
October 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
United States
 
NCT00482586
CDR0000546520, P30CA068485, VU-VICC-GI-0372, VU-VICC-IRB-020874
No
Steven Meranze, Vanderbilt University
Vanderbilt University
National Cancer Institute (NCI)
Study Chair: Steven G. Meranze, MD Vanderbilt-Ingram Cancer Center
Vanderbilt University
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP