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Patient-Defined Treatment Success and Preferences in Stage IV Lung Cancer Patients

Sponsor
University of Nebraska (Other)
Overall Status
Unknown status
CT.gov ID
NCT02190864
Collaborator
Patient-Centered Outcomes Research Institute (Other)
210
Enrollment
8
Locations
30
Duration (Months)
26.3
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Our long-term goal is to integrate non-small cell lung cancer patient treatment preferences into clinical treatment planning.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The following specific aims are proposed:

    Aim 1: Determine whether individual patients' preferences, characteristics, and treatment experiences affect the definition of treatment success.

    Aim 2: Determine how to best predict real-life patients' treatment choices based on patients' preferences of adverse events.

    Aim 3: Determine whether physicians are likely to change their oncologic clinical practice after receiving a detailed communication of their patients' preferences of adverse events.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    210 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Patient-Defined Treatment Success and Preferences in Stage IV Lung Cancer Patients
    Study Start Date :
    Dec 1, 2013
    Anticipated Primary Completion Date :
    Jun 1, 2016
    Anticipated Study Completion Date :
    Jun 1, 2016

    Outcome Measures

    Primary Outcome Measures

    1. Patient-defined "treatment success" [Baseline]

      In advanced stage NSCLC patients does patient-defined "treatment success" differ when both survival and patient preferences of adverse events are accounted for, compared to when success is measured solely by survival? And does it also differ based on individual patient characteristics?

    2. Patients' will to experience adverse events [Baseline]

      Will the serious adverse events that an advanced stage NSCLC patient is willing to experience as part of his/her treatment differ after a real-life treatment experience, compared to before treatment?

    Secondary Outcome Measures

    1. Summary score derived from patient preferences of adverse events [Up to three months]

      In advanced stage NSCLC patients, is a summary score derived from patient preferences of adverse events comparable to a real-life treatment scenario?

    Other Outcome Measures

    1. Physicians' will to select a treatment [Two years]

      Are physicians treating NSCLC patients more likely to select a treatment that matches patients' drug choices when provided standardized, detailed information on patients' preferences of adverse events compared to when they follow regular clinical practice?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Willing and able to provide consent

    • Greater than or equal to 19 years of age

    • Diagnosed with stage IV non-small cell lung cancer (NSCLC)

    • Able to understand spoken English

    • Eligible to undergo chemotherapy for stage IV NSCLC, to include, but not limited to, those who:

    1. have not yet started chemo

    2. are currently undergoing chemo for stage IV NSCLC

    3. have completed first line stage IV NSCLC chemo or progressed to maintenance for stage IV NSCLC within the last 30 days

    4. elect to have chemo elsewhere -- not at one of the study sites

    5. decline chemo

    Exclusion Criteria:

    • Age <19 years

    • Not willing and/or able to provide consent

    • Not able to understand spoken English

    • Not eligible to undergo chemotherapy for stage IV NSCLC

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Moffitt Cancer Center Tampa Florida United States 33612-9416
    2 Kansas City VA Medical Center Kansas City Missouri United States 64128
    3 Saint Francis Cancer Treatment Center Grand Island Nebraska United States 68803
    4 Southeast Nebraska Cancer center Lincoln Nebraska United States 68510
    5 Callahan Cancer Center of Great Plains Regional Medical Center North Platte Nebraska United States 69101
    6 Nebraska-Western Iowa (NWI) VA Health Care System Omaha Nebraska United States 68105
    7 University of Nebraska Medical Center Omaha Nebraska United States 68198
    8 Avera Cancer Institute Sioux Falls South Dakota United States 57105

    Sponsors and Collaborators

    • University of Nebraska
    • Patient-Centered Outcomes Research Institute

    Investigators

    • Principal Investigator: KM Munirul Islam, MD, PhD, University of Nebraska

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    KM Islam, PhD, Principal Investigator, University of Nebraska
    ClinicalTrials.gov Identifier:
    NCT02190864
    Other Study ID Numbers:
    • 318-13-EP
    First Posted:
    Jul 15, 2014
    Last Update Posted:
    Dec 4, 2015
    Last Verified:
    Nov 1, 2015

    Study Results

    No Results Posted as of Dec 4, 2015