Evaluation of the Patient's Experience in Medical Studies for Cholangiocarcinoma

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05694845
Collaborator
(none)
500
24

Study Details

Study Description

Brief Summary

The main reason for conducting this research is to gain a better understanding of why some people with cholangiocarcinoma are not able to participate in or complete clinical trials. Historically, certain groups of people have been more likely to participate in clinical trials, but there hasn't been much research to understand why this is the case.

The goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through. The data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future cholangiocarcinoma patients during clinical trials.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    A Clinical Study Experiences of Cholangiocarcinoma Patients To Identify Trial Attributes Affecting Completion Rates For Specific Demographic Groups
    Anticipated Study Start Date :
    Feb 12, 2023
    Anticipated Primary Completion Date :
    Feb 12, 2024
    Anticipated Study Completion Date :
    Feb 12, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Rate of patients who decide to enroll in a Cholangiocarcinoma Clinical Study. [3 months]

    2. Number of Cholangiocarcinoma patients who remain in clinical trial until completion. [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:
    • Patient is at least 18 years of age

    • Participant has a diagnosis of Cholangiocarcinoma

    • Patient has self-identified as planning to enroll in an interventional Cholangiocarcinoma clinical trial

    • Patient must provide written informed consent

    Exclusion Criteria:
    • No diagnosis of Cholangiocarcinoma confirmed

    • Inability to perform regular electronic reporting

    • Women who are pregnant, intend to become pregnant, or are lactating

    • Patient does not understand, sign, and return consent form

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Power Life Sciences Inc.

    Investigators

    • Study Director: Michael B Gill, Power Life Sciences Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Power Life Sciences Inc.
    ClinicalTrials.gov Identifier:
    NCT05694845
    Other Study ID Numbers:
    • 82275501
    First Posted:
    Jan 23, 2023
    Last Update Posted:
    Jan 30, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Power Life Sciences Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 30, 2023