Particularly Rural/Urban ResidenceNCT02190864
Patient-Defined Treatment Success and Preferences in Stage IV Lung Cancer Patients
An observational study of Particularly Rural/Urban Residence and Gender, run by University of Nebraska at 8 sites in United States.
Trial summary
Our long-term goal is to integrate non-small cell lung cancer patient treatment preferences into clinical treatment planning. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Particularly Rural/Urban Residence, Gender, Age
- How many people
- 210 participants
- Where
- 8 sitesUnited States
- Study dates
- Dec 2013to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Newly diagnosed advanced stage non-small cell lung cancer patients with age > 19 years.
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Saint Francis Cancer Treatment Center
Grand Island, Nebraska, 68803
- Recruiting
Kansas City VA Medical Center
Kansas City, Missouri, 64128
Sarah Spancer, RN, 816-861-4700 ext. 57665, sarah.spancer@va.gov
- Recruiting
Southeast Nebraska Cancer center
Lincoln, Nebraska, 68510
bronson Riley, MS, 402-327-7363, bronsonr@leadingcancercare.com
- Recruiting
Callahan Cancer Center of Great Plains Regional Medical Center
North Platte, Nebraska, 69101
Irfan A Vaziri, MD, 308-696-7864, vazirii@gprmc.com
- Recruiting
Nebraska-Western Iowa (NWI) VA Health Care System
Omaha, Nebraska, 68105
Joy Egan, RN, 402-995-4143, joy.egan@va.gov
- Recruiting
University of Nebraska Medical Center
Omaha, Nebraska, 68198
KM Munirul Islam, MD, PhD, 402-559-8283, kmislam@unmc.edu
- Recruiting
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612-9416
Jhanelle E Gray, MD, 813-745-6895, katie.james@moffitt.org
About this study
Our long-term goal is to integrate non-small cell lung cancer patient treatment preferences into clinical treatment planning.
Read the 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.
- Medical subject headings
- Coitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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?
Measured: 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?
Measured: Baseline
Secondary outcomes (1)
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?
Measured: Up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2014 (estimated)
- Study startDec 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Particularly Rural/Urban ResidenceStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, KM Islam, PhD, University of Nebraska
- Investigators
- KM Munirul Islam, MD, PhD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02190864
- Sponsor's protocol ID
- 318-13-EP
- Status last verified
- Nov 2015
- First submitted
- 2 Jul 2014
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Defined Treatment Success and Preferences in Stage IV Lung Cancer Patients
- ClinicalTrials.gov ID
- NCT02190864
- Acronym / sponsor ID
- 318-13-EP
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Dec 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 15 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Newly diagnosed advanced stage non-small cell lung cancer patients with age > 19 years.
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient-defined "treatment success"
Time frame: 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
Time frame: 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?
1 secondary outcome
Summary score derived from patient preferences of adverse events
Time frame: Up to three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2015.
- Patient Centered Outcomes Research InstituteLink provided by the sponsor.
- University of Nebraska Medical CenterLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KM Munirul Islam, MD, PhD principal investigator
University of Nebraska
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Particularly Rural/Urban Residence and Gender, run by University of Nebraska at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KM Munirul Islam, MD, PhD (402-559-8283, kmislam@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-defined "treatment success" (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2015.