Oncology Research Information Exchange Network (ORIEN) Lung Cancer Study (ORIEN)

February 24, 2023 updated by: H. Lee Moffitt Cancer Center and Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33612
        • H. Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Data Capture Participants
This is a prospective observational cohort study of advanced non-small cell lung cancer patients (stage 3b/4) receiving treatment at the Moffitt Cancer Center (MCC) or The Ohio State Comprehensive Cancer Center (OSUCCC) to assess treatment impact at monthly intervals from baseline to 6 months post-enrollment.
Other: No Intervention
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Cancer Treatment Changes
Time Frame: 6 months post enrollment
Clinical, 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).
6 months post enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Collaborators

AstraZeneca
Genentech, Inc.
Ohio State University Comprehensive Cancer Center
PatientsLikeMe

Investigators

  • Principal Investigator: Matthew Schabath, Ph.D., H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2017

Primary Completion (Actual)

August 18, 2018

Study Completion (Actual)

November 19, 2021

Study Registration Dates

First Submitted

June 14, 2016

First Submitted That Met QC Criteria

June 15, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Estimate)

February 27, 2023

Last Update Submitted That Met QC Criteria

February 24, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCC-18515

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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