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

Metastatic Cancer Clinical Trial

Official title:

Outcomes Following Image-Guided Therapy for Hepatic Malignancies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482586
• Other study ID #: CDR0000546520
• Secondary ID: P30CA068485VU-VI
• Status: Completed
• Phase: N/A
• First received: June 4, 2007
• Last updated: June 3, 2015
• Start date: October 2003
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Liver Cancer
• Liver Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis

Intervention

Other:
• medical chart review
Review the medical charts of patients with hepatic neoplasms who undergo Image-guided Therapy.
• questionnaire administration
Patients with hepatic neoplasms who undergo Image-guided Therapy

Procedure:
• quality-of-life assessment
Patients with hepatic neoplasms who undergo Image-guided Therapy

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		one year	No
Primary	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		one year	No