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A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03672019
Recruitment Status : Active, not recruiting
First Posted : September 14, 2018
Last Update Posted : August 9, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Description
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Brief Summary:
The purpose of this study is to compare the participant's health-related quality of life before and after the biliary drainage procedure. The study will also help us learn whether having a drainage catheter or a stent placed during the procedure makes a difference in the participant's quality of life.

Condition or disease Intervention/treatment
Malignant Biliary Obstruction Behavioral: FACT-Hep

Study Design
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Study Type : Observational
Actual Enrollment : 118 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Health-Related Quality of Life in Patients Undergoing Percutaneous Biliary Drainage For Malignant Biliary Obstruction
Actual Study Start Date : September 11, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2022
Groups and Cohorts
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Group/Cohort Intervention/treatment
Patients Undergoing Percutaneous Biliary Drainage
Following Percutaneous Biliary Drainage (PBD), participants will complete Patient Reported Outcomes (PRO) assessments at baseline and at three time points post-procedure: 4 weeks (+/- 1 weeks), 12 weeks (+/- 2 weeks), and 6 months (+/- 2 weeks).
 Behavioral: FACT-Hep
Patient Reported Outcomes (PRO) assessments at baseline and at three time points post-procedure: 4 weeks (+/- 1 weeks), 12 weeks (+/- 2 weeks), and 6 months (+/- 2 weeks).
Other Name: The Functional Assessment of Cancer Therapy


Outcome Measures
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Primary Outcome Measures :
  1. change in the FACT-Hep scores [ Time Frame: baseline to week 4 post-procedure ]
    The FACT-Hep minimum score is 0 and the maximum is 180.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Potential research subjects will be identified in the interventional radiology clinic or while admitted based on a request for a biliary drainage procedure from their primary oncologist or surgeon at MSK.
Criteria

Inclusion Criteria:

  • Patients with known malignancy presenting for treatment of biliary obstruction
  • Undergoing initial Interventional Radiology PBD procedure
  • Fluent in English to enable instrument completion
  • At least18 years of age
  • Must be physically and mentally capable of completing instruments
  • Must be able to comprehend and execute informed consent

Exclusion Criteria:

  • Patients will be excluded if:

    • Indication for drainage is acute, symptomatic cholangitis requiring an emergent procedure
    • Previous PBD procedure
    • Presence of an indwelling biliary stent
  • Medical or psychiatric condition that, in the judgment of the consenting professional, prevents appropriate comprehension and execution of either the informed consent or the study instruments
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672019


Locations
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United States, New Jersey
Memoral Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, United States, 07920
Memoral Sloan Kettering Monmouth (Consent only)
Middletown, New Jersey, United States, 07748
United States, New York
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester (Consent only)
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
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Principal Investigator: Piera Cote Robson, MSN, CNS, NP Memorial Sloan Kettering Cancer Center
More Information
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Additional Information:

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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03672019    
Other Study ID Numbers: 18-366
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: August 9, 2021
Last Verified: August 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
Percutaneous Biliary Drainage
Quality of life
18-366