Skip to content

Oncology Research Information Exchange Network (ORIEN) Lung Cancer Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02803333
Acronym
ORIEN
Enrollment
75
Registered
2016-06-16
Start date
2017-02-16
Completion date
2021-11-19
Last updated
2023-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer, Non-small Cell Lung Cancer

Keywords

NSCLC, Carcinoma, Non-Small-Cell Lung, Lung Diseases, Thoracic Neoplasms

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.

Interventions

OTHERNo Intervention

No intervention

Sponsors

PatientsLikeMe
CollaboratorOTHER
Ohio State University Comprehensive Cancer Center
CollaboratorOTHER
AstraZeneca
CollaboratorINDUSTRY
Genentech, Inc.
CollaboratorINDUSTRY
H. Lee Moffitt Cancer Center and Research Institute
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Cancer Treatment Changes6 months post enrollmentClinical, molecular, and patient-reported data will be collected from participants. Participants will be asked if their treatment course has changed and, if so, what changes have occurred. These questions are primarily meant to identify the number of patients who were switched from one treatment regimen (e.g., chemotherapy) to either PD-1/PDL-1 inhibitor treatment (immunotherapy) or tyrosine kinase inhibitors (TKIs).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026