Lung Cancer Clinical Trial
— ORIENOfficial 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
Verified date | February 2023 |
Source | H. Lee Moffitt Cancer Center and Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | AstraZeneca, Genentech, Inc., Ohio State University Comprehensive Cancer Center, PatientsLikeMe |
United States,
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 |
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