Examination of Trends in Multiple Myeloma Trial Patient Experiences

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05860179
Collaborator
(none)
500
24

Study Details

Study Description

Brief Summary

Historically, participation in clinical trials has been highly skewed towards specific demographic groups. However, research identifying which trial attributes impact participation, in either positive or negative ways, is limited.

This study invites participants to record a wide range of data on their clinical trial experience, with the goal being to identify factors which persistently limit patients' ability to participate in, or complete, a trial in which they were initially interested.

Data will be analyzed through a range of demographic lenses, in hopes of discovering patterns which might improve the experience of future multiple myeloma patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Analyzing Factors of Patient Involvement in Multiple Myeloma Clinical Trials
    Anticipated Study Start Date :
    May 1, 2024
    Anticipated Primary Completion Date :
    May 1, 2025
    Anticipated Study Completion Date :
    May 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Number of participants with multiple myeloma who decide to enroll in clinical trial [3 Months]

    2. Rate of patients with multiple myeloma who remain in clinical trial to completion [12 month]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed

    • Patient has been diagnosed with multiple myeloma

    • Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

    Exclusion Criteria:
    • Inability to perform regular electronic reporting

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

    • Pregnant, breastfeeding or expecting to conceive within the projected duration of the study

    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:
    NCT05860179
    Other Study ID Numbers:
    • 80736578
    First Posted:
    May 16, 2023
    Last Update Posted:
    May 23, 2023
    Last Verified:
    Apr 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 May 23, 2023