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

Gender Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02190864
• Other study ID #: 318-13-EP
• Status: Unknown status
• Phase: N/A
• First received: July 2, 2014
• Last updated: December 3, 2015
• Start date: December 2013
• Est. completion date: June 2016

Study information

• Verified date: November 2015
• Source: University of Nebraska
• Contact: KM Munirul Islam, MD, PhD
• Phone: 402-559-8283
• Email: kmislam[@]unmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 210
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Saint Francis Cancer Treatment Center	Grand Island	Nebraska
United States	Kansas City VA Medical Center	Kansas City	Missouri
United States	Southeast Nebraska Cancer center	Lincoln	Nebraska
United States	Callahan Cancer Center of Great Plains Regional Medical Center	North Platte	Nebraska
United States	Nebraska-Western Iowa (NWI) VA Health Care System	Omaha	Nebraska
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Avera Cancer Institute	Sioux Falls	South Dakota
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Nebraska	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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

External Links

•   Avera Cancer Institute
•   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