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

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

Study Overview

• Status: Unknown
• Conditions: Gender; Age; Comorbid Conditions; Particularly Rural/Urban Residence; FACT-TOI Scores

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 Type: Observational
• Enrollment (Anticipated): 210

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612-9416
      • Recruiting
      • Moffitt Cancer Center
      • Contact: Jhanelle E Gray, MD; Phone Number: 813-745-6895; Email: katie.james@moffitt.org
  • Missouri
    • Kansas City, Missouri, United States, 64128
      • Recruiting
      • Kansas City VA Medical Center
      • Contact: Sarah Spancer, RN; Phone Number: 57665 816-861-4700; Email: sarah.spancer@va.gov
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Recruiting
      • Saint Francis Cancer Treatment Center
    • Lincoln, Nebraska, United States, 68510
      • Recruiting
      • Southeast Nebraska Cancer Center
      • Contact: bronson Riley, MS; Phone Number: 402-327-7363; Email: bronsonr@leadingcancercare.com
    • North Platte, Nebraska, United States, 69101
      • Recruiting
      • Callahan Cancer Center of Great Plains Regional Medical Center
      • Contact: Irfan A Vaziri, MD; Phone Number: 308-696-7864; Email: vazirii@gprmc.com
    • Omaha, Nebraska, United States, 68198
      • Recruiting
      • University of Nebraska Medical Center
      • Contact: KM Munirul Islam, MD, PhD; Phone Number: 402-559-8283; Email: kmislam@unmc.edu
    • Omaha, Nebraska, United States, 68105
      • Recruiting
      • Nebraska-Western Iowa (NWI) VA Health Care System
      • Contact: Joy Egan, RN; Phone Number: 402-995-4143; Email: joy.egan@va.gov
  • South Dakota
    • Sioux Falls, South Dakota, United States, 57105
      • Recruiting
      • Avera Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed advanced stage non-small cell lung cancer patients with age > 19 years.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient-defined "treatment success"	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?	Baseline
Patients' will to experience adverse events	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?	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Summary score derived from patient preferences of adverse events	In advanced stage NSCLC patients, is a summary score derived from patient preferences of adverse events comparable to a real-life treatment scenario?	Up to three months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physicians' will to select a treatment	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?	Two years

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: Patient-Centered Outcomes Research Institute
• Investigators: Principal Investigator: KM Munirul Islam, MD, PhD, University of Nebraska

Publications and helpful links

Helpful Links

• Callahan Cancer Center of Great Plains Regional Medical Center
• Patient Centered Outcomes Research Institute
• Saint Francis Cancer Treatment Center
• University of Nebraska Medical Center
• UNMC IRB

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: July 2, 2014
• First Submitted That Met QC Criteria: July 11, 2014
• First Posted (Estimate): July 15, 2014

Study Record Updates

• Last Update Posted (Estimate): December 4, 2015
• Last Update Submitted That Met QC Criteria: December 3, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: 318-13-EP