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/40511978/Actively Recruiting
Led by Ohio State University Comprehensive Cancer Center · Updated on 2026-06-17
3584
Participants Needed
1
Research Sites
104 weeks
Total Duration
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, offer better toxicity profiles than conventional chemotherapy, and impact quality of life. The study includes patients newly diagnosed or diagnosed within the previous year with stage IV NSCLC. Participants are randomized to one of two groups one group receives usual care along with collection of tumor tissue and blood samples for a research repository, while the other group undergoes advanced genomic and immunotherapy testing AGIT including tumor and blood analyses. Additionally, a smoking cessation intervention is offered to current or recent smokers and their household members through either usual care or centralized telephone counseling with decision support. The study also involves correlative studies to identify biomarkers related to immunotherapy response and immune-related adverse events. During the study, participants provide medical records, insurance and billing data, biospecimens, and complete questionnaires through phone, online, or in-person formats. Researchers monitor survival, quality of life using validated questionnaires, smoking cessation outcomes, and the use of genomic testing and targeted therapies. The study duration includes a three-month observation period followed by a 21-month randomized trial phase, with outcomes assessed up to three years. This comprehensive approach helps track the impact of advanced genomic testing and decision support on patient care and survival.
CONDITIONS
Beating Lung Cancer in Ohio Protocol in Improving Survival in Patients With Stage IV Non-Small Cell Lung Cancer
T
The Ohio State University Comprehensive Cancer Center
S
Sarah Reisinger
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Ohio State University Comprehensive Cancer Center
Lead Sponsor
This table compares participation in this trial with other options available for this condition. The information is drawn from published research and the trial’s study details and is provided for educational purposes only.
| Factors | NCCN‑guided cessation support (Arm II) | Usual care (Arm I) |
|---|---|---|
| What each option is | Enhanced smoking cessation support guided by NCCN‑based counseling and decision‑support (AGIT/DS) plus biospecimen and quality‑of‑life assessments | Provision of usual smoking cessation resources and standard care referrals |
| Role in the study | Serves as the investigational enhancement arm evaluated against usual care | Serves as the comparator arm representing standard cessation practice |
| Aim of intervention | Deliver structured NCCN‑driven cessation counseling, decision support, biospecimen collection, and quality‑of‑life assessments | Provide standard smoking cessation referral and resources |
| How it is performed | Counseling and decision support based on NCCN cessation guidelines, with biospecimen and quality‑of‑life data collected | Standard care pathway as per routine practice |
| External evidence on smoking cessation in lung cancer | Structured evidence‑based counseling plus pharmacotherapy improves quit rates over usual care in cancer patients | Evidence indicates that quitting smoking early after NSCLC diagnosis is associated with improved survival |
| Important risks | Risks are minimal and align with non‑invasive behavioral support | Risks are minimal and reflect standard referral processes |
| Important limitations | Requires more resources, coordination, and biospecimen collection infrastructure | May result in lower quit success rates compared with structured intervention |
Disclaimer: This comparison is created with the help of artificial intelligence(AI) and may contain errors or missing information. It is not medical advice and does not mean one option is better or safer than another. Clinical trials are still being studied, and joining a trial is your choice. Please consult your healthcare professional before making any decisions.
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 3 months
Participants newly diagnosed with stage IV NSCLC are observed for 3 months to document usual care practices, survival, and quality of life.
Regular follow-ups as per usual care
Duration - 21 months
Participants are randomized to receive either usual care or advanced genomic and immunotherapy testing with decision support. Smoking cessation support is offered to eligible smokers and their household members.
Medical record reviews and patient recontact at intervals
Duration - Up to 3 years
Researchers monitor survival, quality of life, treatment use, and smoking cessation outcomes for up to 3 years.
Questionnaires and data collection at scheduled times
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/39325429/Ohio State University Comprehensive Cancer Center
Lead Sponsor