Discovering Factors in Metastatic Breast Cancer Patients' Clinical Trial Experiences

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05760183
Collaborator
(none)
500
24

Study Details

Study Description

Brief Summary

Enrollment in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups.

This trial will evaluate the safety and efficacy of metastatic breast cancer treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future metastatic breast cancer studies.

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 Medical Trial Assessing Patterns in Experiences of Participants of Metastatic Breast Cancer Clinical Trials
    Anticipated Study Start Date :
    Mar 25, 2023
    Anticipated Primary Completion Date :
    Mar 25, 2024
    Anticipated Study Completion Date :
    Mar 25, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Rate of patients who decide to enroll in a metastatic breast cancer clinical study. [3 months]

    2. Number of metastatic breast cancer study participants 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
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patient is at least 18 years of age

    • Patient is able and willing to comply with the treatment/follow-up schedule and requirements

    • Patient must provide written informed consent

    Exclusion Criteria:
    • Women who are pregnant, intend to become pregnant, or are lactating

    • Inability to perform regular electronic reporting

    • Participants who are vulnerable to any intervention

    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:
    NCT05760183
    Other Study ID Numbers:
    • 82944089
    First Posted:
    Mar 8, 2023
    Last Update Posted:
    Mar 8, 2023
    Last Verified:
    Feb 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 Mar 8, 2023