Oncology Research Information Exchange Network (ORIEN) Lung Cancer Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-16

Study Completion Date

2021-11-19

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lung Cancer Non-small Cell Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No Intervention

Intervention Type OTHER

No intervention

Interventions

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No Intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No