Quality Of Life in Patients With Malignant Biliary Obstruction

NCT00579865 | Completed

• 1 other identifier: 04-036
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

You may have symptoms like itching, abdominal pain, loss of appetite, fatigue, fevers and chills. The treatment you will receive to relieve the blockage is also intended to relieve symptoms and improve your quality of life. The purpose of this study is to find out if relieving the blockage in your bile duct improves your quality of life.

Conditions

Gallbladder Cancer; Liver Cancer; Bile Duct Cancer

Keywords

Quality of Life

Outcome Measures

Primary Outcomes (1)

• To determine how surgical or percutaneous drainage affects HRQL scores in patients with MBO, and to determine if these changes are sustained or change over time.

  conclusion of the study

Secondary Outcomes (1)

• To identify factors associated with changes in HRQL after drainage(e.g. diagnosis, level of obstruction, degree of pruritus)

  conclusion of the study

Study Arms (2)

Group A

Patients scheduled for percutaneous drainage

Behavioral: questionnaires

Group B

Patients scheduled for a surgical bypass or resection of a high bile duct tumor.

Behavioral: questionnaires

Interventions

questionnaires BEHAVIORAL

complete the FACT-Hep, the SSQ, and the Visual Analog Scale for Pruritus Assessment at 1 week and 4 weeks post procedure.

Group A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

MSKCC clinics

You may qualify if:

• Clinical diagnosis of malignant biliary obstruction
• Radiologic or histologic evidence of MBO
• Percutaneous biliary drainage procedure planned or
• Surgical biliary enteric bypass, or hepatic resection with biliary reconstruction (high bile duct tumors) planned
• KPS \>50%
• Age 18 years or greater
• Able to speak and read English
• Able to comprehend and execute informed consent

You may not qualify if:

• Unable to complete questionnaire due to performance status
• Proxy completion is not accepted
• Medical or psychiatric condition that, in the judgment of the investigator, prevents appropriate comprehension and execution of either the informed consent or the study instrument

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Gallbladder Neoplasms; Liver Neoplasms; Bile Duct Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Biliary Tract Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases; Gallbladder Diseases; Liver Diseases; Bile Duct Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Piera Robson, RN, BSN

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 20, 2007
• First Posted: December 24, 2007
• Study Start: May 1, 2005
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: January 14, 2010

Record last verified: 2010-01

Locations

US (1)