Oncology Research Information Exchange Network (ORIEN) Lung Cancer Study

Lung Cancer Clinical Trial

— ORIEN  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02803333
• Other study ID #: MCC-18515
• Status: Completed
• Start date: February 16, 2017
• Est. completion date: November 19, 2021

Study information

• Verified date: February 2023
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: November 19, 2021
• Est. primary completion date: August 18, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Non-small Cell Lung Cancer

Intervention

Other:
• No Intervention
No intervention

Locations

Country	Name	City	State
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida

Sponsors (5)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	AstraZeneca, Genentech, Inc., Ohio State University Comprehensive Cancer Center, PatientsLikeMe

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Cancer Treatment Changes	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

External Links

•   Moffitt Cancer Center Clinical Trials website