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A Quality of Life Study in Patients Undergoing Percutaneous Biliary Drainage

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03672019
Collaborator
(none)
118
Enrollment
5
Locations
59.7
Anticipated Duration (Months)
23.6
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Behavioral: FACT-Hep

Study Design

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 :
Sep 11, 2018
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Sep 1, 2023

Arms and Interventions

Arm 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 Names:
  • The Functional Assessment of Cancer Therapy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. change in the FACT-Hep scores [baseline to week 4 post-procedure]

      The FACT-Hep minimum score is 0 and the maximum is 180.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Memoral Sloan Kettering Basking Ridge (Consent only) Basking Ridge New Jersey United States 07920
    2 Memoral Sloan Kettering Monmouth (Consent only) Middletown New Jersey United States 07748
    3 Memorial Sloan Kettering Commack (Consent only) Commack New York United States 11725
    4 Memorial Sloan Kettering Westchester (Consent only) Harrison New York United States 10604
    5 Memorial Sloan Kettering Cancer Center New York New York United States 10065

    Sponsors and Collaborators

    • Memorial Sloan Kettering Cancer Center

    Investigators

    • Principal Investigator: Piera Cote Robson, MSN, CNS, NP, Memorial Sloan Kettering Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Memorial Sloan Kettering Cancer Center
    ClinicalTrials.gov Identifier:
    NCT03672019
    Other Study ID Numbers:
    • 18-366
    First Posted:
    Sep 14, 2018
    Last Update Posted:
    Aug 9, 2022
    Last Verified:
    Aug 1, 2022
    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

    Study Results

    No Results Posted as of Aug 9, 2022