Exploring Clinical Trial Experiences of People With Leiomyosarcoma

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05548179
Collaborator
(none)
500
24

Study Details

Study Description

Brief Summary

Clinical study participation has historically been heavily biased toward specific demographics.

Several people will be invited to enroll in this study so that it may collect a variety of data about leiomyosarcoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with leiomyosarcoma who are invited to take part in medical research will benefit from the analysis of the data.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    An In Depth Study Investigating The Experiences of Patients In Leiomyosarcoma Clinical Trials
    Anticipated Study Start Date :
    Oct 16, 2022
    Anticipated Primary Completion Date :
    Oct 16, 2023
    Anticipated Study Completion Date :
    Oct 16, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients who decide to enroll in an leiomyosarcoma clinical trial [3 months]

    2. Rate of patients who remain in leiomyosarcoma clinical trial to trial completion [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient has self-identified as planning to enroll in an interventional clinical trial

    • Patient has been diagnosed with leiomyosarcoma

    • Patient is a minimum of 18 years or older

    Exclusion Criteria:
    • Patient does not understand, sign, and return consent form

    • Inability to perform regular electronic reporting

    • Patient is pregnant

    • ECOG score of 4

    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:
    NCT05548179
    Other Study ID Numbers:
    • 87688730
    First Posted:
    Sep 21, 2022
    Last Update Posted:
    Sep 21, 2022
    Last Verified:
    Sep 1, 2022
    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 Sep 21, 2022