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Assessing Clinical Trial Experiences of Patients With Osteosarcoma

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05535283
Collaborator
(none)
500
Enrollment
24
Anticipated Duration (Months)

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 osteosarcoma clinical trial experiences and identify barriers to participation as well as the causes of participants' failure or withdrawal.

People with osteosarcoma 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 Observational Study Investigating The Experiences of Patients In Osteosarcoma Clinical Trials
    Anticipated Study Start Date :
    Oct 6, 2022
    Anticipated Primary Completion Date :
    Oct 6, 2023
    Anticipated Study Completion Date :
    Oct 6, 2024

    Outcome Measures

    Primary Outcome Measures

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

    2. Rate of patients who remain in osteosarcoma 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 been diagnosed with osteosarcoma

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

    • Patient is a minimum of 18 years or older

    Exclusion Criteria:

    • ECOG score of 4

    • Patient is pregnant

    • Inability to perform regular electronic reporting

    • 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:
    NCT05535283
    Other Study ID Numbers:
    • 83926159
    First Posted:
    Sep 10, 2022
    Last Update Posted:
    Sep 10, 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.
    osteosarcoma
    Additional relevant MeSH terms:
    Osteosarcoma

    Study Results

    No Results Posted as of Sep 10, 2022