Depression and Inflammation Predict Depression Trajectory of Non-Small Cell Lung Cancer Patients.
Kylie R Park, Peter G Shields, John V Myers...
https://pubmed.ncbi.nlm.nih.gov/40511978Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID03199651
Beating Lung Cancer in Ohio Protocol to Improve Survival in Stage IV Non-Small Cell Lung Cancer
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-02-19
3584
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the Beating Lung Cancer in Ohio protocol to improve survival in patients with stage IV non-small cell lung cancer (NSCLC). This study focuses on assessing immunotherapies and targeted therapies that may extend survival and have better toxicity profiles than standard chemotherapy, while also examining their impact on quality of life. The trial includes patients newly diagnosed or diagnosed within the past year, using a statewide research network and a cohort from Ohio State University. The study has multiple phases including a 3-month observation period documenting usual care practices, survival, and quality of life in patients with stage IV NSCLC. Following this, a 21-month cluster-randomized clinical trial is conducted in two phases, comparing usual care with advanced genomic and immunotherapy testing (AGIT), and then AGIT with decision support from a genomics board. Patients who smoke or recently quit, along with their household members who smoke, may participate in a 1-year smoking cessation trial using usual care or centralized telephone counseling with decision support. Biospecimens including tumor tissue and blood samples are collected for biomarker studies. Participants will undergo medical record reviews, quality-of-life questionnaires, and biospecimen collections. Researchers will monitor overall survival, progression-free survival, use of targeted therapies, genomic testing rates, enrollment in clinical trials, and smoking cessation outcomes. Biomarker analyses will assess tumor epigenetics and immune profiles related to immunotherapy response and adverse events. Study-related care and follow-ups last up to three years, with specific assessments at various intervals to evaluate outcomes and safety.
CONDITIONS
Brief Title
Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients With Stage IV Non-Small Cell Lung Cancer
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed stage IV non-small cell lung cancer (any NSCLC type) with imaging available or likely stage IV per physician judgment
- Enrollment possible if patient cannot be reached by first office visit, preferably before starting therapy and no later than one month after starting therapy
- English speaking
- Willing to provide access to medical records, insurance and billing data, biospecimens and respond to questionnaires
- For smoking cessation trial: current smokers or recent quitters smoking at least one cigarette most days per week (within 3 months)
- Household members must be current smokers smoking at least one cigarette most days per week
- No hearing or vision impairments preventing consent, interviews, or sample collection
You will not qualify if you...
- Receiving definitive chemoradiotherapy or surgery
- Receiving treatment for advanced lung cancer for over one month before enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Observation Period
Duration - 3 months
Participants newly diagnosed with stage IV non-small cell lung cancer are observed for 3 months to document usual care practices, survival, and quality of life.
Visits as part of usual care during the 3 months
Treatment
Duration - Up to 21 months
Participants receive either usual care or advanced genomic and immunotherapy testing (AGIT) with or without decision support. Tumor tissue and blood samples are collected for analysis and repository. Participants who smoke or recently quit and their household members may undergo smoking cessation interventions.
Visits as part of usual care and study assessments during treatment period
Follow-up
Duration - Up to 3 years
Participants are monitored for survival, quality of life, and clinical outcomes up to 3 years after enrollment.
Periodic assessments according to study schedule
Trial Site Locations
Total: 1 location
1
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
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Research Team
T
The Ohio State University Comprehensive Cancer Center
S
Sarah Reisinger
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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Published Research Related To This Trial
Lung cancer patients' illness perceptions: Prognostic for psychological and physical health trajectories.
Thomas R Valentine, Kylie R Park, Carolyn J Presley...
https://pubmed.ncbi.nlm.nih.gov/39325429COVID-19 or Cancer Stress? Anxiety and Depressive Symptoms in Patients with Advanced Lung Cancer.
Tessa R Blevins, Stephen B Lo, Clarence A Coker...
https://pubmed.ncbi.nlm.nih.gov/37594667Depression in association with neutrophil-to-lymphocyte, platelet-to-lymphocyte, and advanced lung cancer inflammation index biomarkers predicting lung cancer survival.
Barbara L Andersen, John Myers, Tessa Blevins...
https://pubmed.ncbi.nlm.nih.gov/36827396Illness perception profiles and psychological and physical symptoms in newly diagnosed advanced non-small cell lung cancer.
Thomas R Valentine, Carolyn J Presley, David P Carbone...
https://pubmed.ncbi.nlm.nih.gov/35604701Cancer Treatment During COVID-19: Resilience of Individuals With Advanced Non-Small Cell Lung Cancer Versus Community Controls.
Nicole A Arrato, Stephen B Lo, Clarence A Coker...
https://pubmed.ncbi.nlm.nih.gov/35130505Psychological Symptom Trajectories and Non-Small Cell Lung Cancer Survival: A Joint Model Analysis.
Barbara L Andersen, Joseph P McElroy, David P Carbone...
https://pubmed.ncbi.nlm.nih.gov/34629425Newly diagnosed patients with advanced non-small cell lung cancer: A clinical description of those with moderate to severe depressive symptoms.
B L Andersen, T R Valentine, S B Lo...
https://pubmed.ncbi.nlm.nih.gov/31806360