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

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

• Registration Number: NCT02190864
• Lead Sponsor: University of Nebraska

Brief Summary

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

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 Timeline

• Study Start: 2013-12
• Study First Submitted: 2014-07-02
• Study First Submitted QC: 2014-07-11
• Study First Posted: 2014-07-15
• Status Verified: 2015-11
• Last Update Submitted: 2015-12-03
• Last Update Posted: 2015-12-04
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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?
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

Name	Time	Method
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?

Trial Locations

Locations (8)

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Nebraska-Western Iowa (NWI) VA Health Care System; 🇺🇸 Omaha, Nebraska, United States

Kansas City VA Medical Center; 🇺🇸 Kansas City, Missouri, United States

Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Avera Cancer Institute; 🇺🇸 Sioux Falls, South Dakota, United States

Southeast Nebraska Cancer center; 🇺🇸 Lincoln, Nebraska, United States

Saint Francis Cancer Treatment Center; 🇺🇸 Grand Island, Nebraska, United States

Callahan Cancer Center of Great Plains Regional Medical Center; 🇺🇸 North Platte, Nebraska, United States