Clinical trial NCT02190864: Patient-Defined Treatment Success and Preferences in Stage IV Lung Cancer Patients
Official title: Patient-Defined Treatment Success and Preferences in Stage IV Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Particularly Rural/Urban Residence
Gender
Age
FACT-TOI Scores
Comorbid Conditions
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-07-15
Enrollment: 210
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed advanced stage non-small cell lung cancer patients with age \> 19 years.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient-defined "treatment success"
timeFrame: Baseline
measure: Patients' will to experience adverse events
timeFrame: Baseline
Secondary outcomes:
measure: Summary score derived from patient preferences of adverse events
timeFrame: Up to three months
Other outcomes:
measure: Physicians' will to select a treatment
timeFrame: Two years
Locations:
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Kansas City
country: United States
facility: Kansas City VA Medical Center
state: Missouri
city: Grand Island
country: United States
facility: Saint Francis Cancer Treatment Center
state: Nebraska
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer center
state: Nebraska
city: North Platte
country: United States
facility: Callahan Cancer Center of Great Plains Regional Medical Center
state: Nebraska
city: Omaha
country: United States
facility: Nebraska-Western Iowa (NWI) VA Health Care System
state: Nebraska
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Sioux Falls
country: United States
facility: Avera Cancer Institute
state: South Dakota
Study officials:
affiliation: University of Nebraska
name: KM Munirul Islam, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: