Clinical trial NCT02803333: Oncology Research Information Exchange Network (ORIEN) Lung Cancer Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Cancer
Non-small Cell Lung Cancer
Keywords: NSCLC
Carcinoma, Non-Small-Cell Lung
Lung Diseases
Thoracic Neoplasms
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: PatientsLikeMe
name: Ohio State University Comprehensive Cancer Center
name: AstraZeneca
name: Genentech, Inc.
First posted: 2016-06-16
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Advanced non-small cell lung cancer patients (stage 3b/4) receiving treatment at the Moffitt Cancer Center (MCC) or The Ohio State University Comprehensive Cancer Center (OSUCCC)

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of Participants with Cancer Treatment Changes
timeFrame: 6 months post enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Matthew Schabath, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: