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

NCT02190864 | Unknown

• 1 other identifier: 318-13-EP
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Summary score derived from patient preferences of adverse events

  Up to three months

Other Outcomes (1)

• Physicians' will to select a treatment

  Two years

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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:
• have not yet started chemo
• are currently undergoing chemo for stage IV NSCLC
• have completed first line stage IV NSCLC chemo or progressed to maintenance for stage IV NSCLC within the last 30 days
• elect to have chemo elsewhere -- not at one of the study sites
• decline chemo

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (8)

Moffitt Cancer Center

Tampa, Florida, 33612-9416, United States

RECRUITING

Kansas City VA Medical Center

Kansas City, Missouri, 64128, United States

RECRUITING

Saint Francis Cancer Treatment Center

Grand Island, Nebraska, 68803, United States

RECRUITING

Southeast Nebraska Cancer center

Lincoln, Nebraska, 68510, United States

RECRUITING

Callahan Cancer Center of Great Plains Regional Medical Center

North Platte, Nebraska, 69101, United States

RECRUITING

Nebraska-Western Iowa (NWI) VA Health Care System

Omaha, Nebraska, 68105, United States

RECRUITING

University of Nebraska Medical Center

Omaha, Nebraska, 68198, United States

RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, 57105, United States

RECRUITING

Related Links

• Patient Centered Outcomes Research Institute
• University of Nebraska Medical Center

MeSH Terms

Conditions

Coitus

Condition Hierarchy (Ancestors)

Sexual Behavior; Behavior

Study Officials

• KM Munirul Islam, MD, PhD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Central Study Contacts

KM Munirul Islam, MD, PhD

CONTACT

402-559-8283; kmislam@unmc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 2, 2014
• First Posted: July 15, 2014
• Study Start: December 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: December 4, 2015

Record last verified: 2015-11

Locations

US (8)