Oncology Research Information Exchange Network (ORIEN) Lung Cancer Study



Status:Active, not recruiting
Conditions:Lung Cancer, Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/6/2018
Start Date:June 14, 2016
End Date:November 2020

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Symptoms, Toxicity Prevalence and Quality of Life Benefit of Targeted Therapies and Immunotherapies in Lung Cancer Patients: An Observational Prospective Cohort Study Within the Total Cancer Care Population

The Moffitt Cancer Center and PatientsLikeMe.com (PLM), an online patient community, are
working together to better understand the patient's entire lung cancer experience, both
inside and outside the doctor's office. By combining the data that is captured by their care
team in the clinic with the data participants enter at their home on PatientsLikeMe.com, the
investigators hope to improve patient-physician treatment decisions, so that the patient's
personal treatment goals and quality of life have the highest chances of being fulfilled.

The aim of the study is to assess the real-world patient experience by evaluating the
patients' quality of life, treatment toxicities, and clinical measures over a 6-month period.
The ultimate goal of this research is to improve patient-physician treatment decisions, so
that the patient's personal treatment goals and quality of life have the highest chances of
being fulfilled.

Aim 1. To track the toxicities/side-effects of FDA approved molecular targeted agents,
immunotherapies, and combinations of treatments for NSCLC in a clinical setting for six
months.

Aim 2. To assess the impact of these treatment regimens on patient toxicities, symptoms,
function, and quality of life, after adjustment for clinical factors and patient
characteristics during the 6 month follow-up period.

Inclusion Criteria:

- >= 18 years of age

- Diagnosed with metastatic (stage 3b/4) non-small cell lung cancer (NSCLC)

- The total combined sample size must include at least 100 people who received one or
more treatments of PD-1/PDL-1 inhibitor treatment (immunotherapy), and 50 patients who
received an Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor (EGFR-TKI).
Patients receiving any other treatments will be tracked for treatment outcomes, as
well as to serve as comparison participants during data analyses of outcomes
associated with PD-1/PDL-1 or EGFR-TKI).

- Consented separately to the Total Cancer Care (TCC) protocol

- Have access to the internet

- Willing to enroll in the free online health tracking and patient community
"PatientsLikeMe"

Exclusion Criteria:

- Patients enrolled in Phase I clinical trial protocols

- Patients enrolled in Phase II, III or IV clinical trials involving blinded therapies
(patients in open label trials will be eligible)
We found this trial at
1
site
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
Principal Investigator: Matthew Schabath, Ph.D.
Phone: 813-745-2926
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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mi
from
Tampa, FL
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