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Administrative data

NCT number NCT02190864
Other study ID # 318-13-EP
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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