New Treatment Protocol for Advanced Lung Cancer

(BLCIO Trial)

Overseen By Sarah Reisinger

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Disqualifiers: Chemoradiotherapy, Surgery, Advanced treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

3584 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines new treatments for individuals with stage IV non-small cell lung cancer, focusing on therapies that may improve survival and quality of life. It compares usual care with advanced methods, including a specific smoking cessation program called Episodic Future Thinking (EFT) for patients and their household members who smoke. Suitable candidates include those with confirmed stage IV lung cancer who currently smoke or recently quit, smoking at least one cigarette most days. Participants must also be comfortable sharing medical records and participating in surveys. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Beating Lung Cancer in Ohio protocol is safe for patients with stage IV non-small cell lung cancer?

Research has shown that programs to help people quit smoking, like the one in this trial, are generally safe. These programs often use a method called episodic future thinking (EFT), which helps people envision their life without smoking. Studies have found that EFT does not cause serious side effects.

In one study, EFT helped smokers reduce their cravings without harm. Another study demonstrated that quitting smoking programs did not cause significant negative effects over time.

In summary, programs to stop smoking are usually well-tolerated and have not shown major safety concerns in past research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it's exploring innovative ways to help patients with advanced lung cancer by combining usual care with advanced genetic analysis and smoking cessation strategies. Unlike standard treatments that mainly focus on chemotherapy, radiation, or targeted therapy, this trial incorporates the FoundationOne assay and FoundationACT blood circulating tumor DNA assay to analyze tumor and blood samples, offering personalized insights into the cancer's genetic makeup. This approach could lead to more tailored treatment plans and potentially better outcomes. Additionally, the trial emphasizes smoking cessation, which is crucial since quitting smoking can significantly improve cancer treatment efficacy and overall health.

What evidence suggests that this trial's treatments could be effective for advanced lung cancer?

Research has shown that quitting smoking can greatly improve health for people with lung cancer. Successfully stopping smoking links to fewer complications and better chances of living longer. In this trial, participants may receive a smoking cessation intervention, which includes methods like imagining future events to help reduce smoking and cravings. For those with lung cancer, quitting smoking could be crucial for feeling better and living longer. These findings indicate that stopping smoking is a helpful step for patients with stage IV non-small cell lung cancer. ^{1 2 3 5 6}

Who Is on the Research Team?

Peter G. Shields, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for English-speaking adults with stage IV non-small cell lung cancer (NSCLC), including current or recent smokers. Participants must be willing to share medical records and biospecimens, and complete questionnaires. They should not have hearing or vision impairments that would affect their participation, nor should they have been treated for advanced lung cancer for over a month before joining.

Inclusion Criteria

No hearing and vision impairments that would prevent ability to complete consent, interviews, or sample collection

My lung cancer is at stage IV, and I have images or a doctor's opinion to support this.

Willing to provide access to medical records, insurance and billing data, biospecimens, and respond to questionnaires

Exclusion Criteria

I have been treated for advanced lung cancer for more than a month.

I am currently undergoing treatment with chemotherapy and radiation, or I have had surgery.

Timeline for a Trial Participant

Observation

Establish a 3 month observation period for newly diagnosed stage IV non-small cell lung cancer patients, documenting usual care practices, survival, and quality of life.

3 months

Treatment Phase 1

Over 9 months, sites will be randomized to offer patients either usual care or free advanced genomic and immunotherapy testing, followed by medical record review and recontacting of patients.

9 months

Treatment Phase 2

Over 12 months, sites will be randomized to offer patients advanced genomic and immunotherapy testing or testing with decision support through a genomics board, followed by medical record review and recontacting of patients.

12 months

Smoking Cessation Intervention

Conduct a 1 year smoking cessation intervention trial where subjects are randomized by site to receive usual care or NCCN-driven centralized telephone counseling and decision support.

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including survival and quality of life assessments.

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Smoking Cessation Intervention

Trial Overview The 'Beating Lung Cancer in Ohio' protocol is being tested to see if it can improve survival rates by using immunotherapies and targeted therapies instead of conventional chemotherapy. These treatments are expected to be less toxic and may positively impact the quality of life.

How Is the Trial Designed?

Group I: Arm II (AGIT/DS) Experimental Treatment 6 Interventions

Patients undergo collection of tumor tissue for analysis using FoundationOne assay and blood sample for analysis using FoundationACT blood circulating tumor DNA assay. Patients who smoke or have recently quit smoking and their household members who smoke may also undergo smoking cessation via usual care or NCCN driven-CTC/DS.

Group II: Arm I (UC) Active Control 7 Interventions

Patients receive usual care and undergo collection of tumor tissue and blood sample for the repository. Patients who smoke or have recently quit smoking and their household members who smoke may also undergo smoking cessation via usual care or NCCN driven-CTC/DS.

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Published Research Related to This Trial

Acceptance and Commitment Therapy (ACT) was found to be as feasible as Cognitive Behavioral Therapy (CBT) for smoking cessation in a preliminary trial involving 81 adult smokers, with both treatments delivered over seven weekly sessions.

ACT showed promising effectiveness, with a 30.2% smoking cessation rate at 12 months compared to 13.2% for CBT, indicating that ACT may be a more effective option for helping smokers quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment therapy for smoking cessation: a preliminary study of its effectiveness in comparison with cognitive behavioral therapy. Hernández-López, M., Luciano, MC., Bricker, JB., et al.[2022]

A study of 111 cancer patients in a smoking cessation program revealed that most were Caucasian, married, and diagnosed with head and neck cancer, indicating specific demographic trends among those who continue to smoke after diagnosis.

Quit motivation was positively linked to higher self-efficacy and perceived benefits of quitting, while negatively associated with nicotine addiction and depressive symptoms, suggesting that tailored interventions addressing these factors could improve cessation efforts in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics of cancer patients entering a smoking cessation program and correlates of quit motivation: implications for the development of tobacco control programs for cancer patients. Schnoll, RA., Rothman, RL., Newman, H., et al.[2022]

Psychological interventions have been shown to be effective in helping people quit smoking, especially for those with a history of depression, and they can enhance the effectiveness of nicotine replacement therapy.

There is a need for further research to explore the effectiveness of psychological interventions for other diagnostic groups and for smokers who are not yet ready to quit, to develop tailored approaches for these populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychological interventions: state of the art. Hall, SM.[2019]

The combination of cognitive-behavioral treatment (CBT) and episodic future thinking (EFT) for smoking cessation in a group of 29 smokers with substance use disorders was found to be acceptable, with a high satisfaction rating of 8.83 out of 10.

Despite the positive reception, adherence to the EFT component was low, with only 15.8% of participants practicing it as recommended, indicating a need for adjustments in future studies to enhance compliance and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Episodic future thinking for smoking cessation in individuals with substance use disorder: Treatment feasibility and acceptability. Aonso-Diego, G., González-Roz, A., Martínez-Loredo, V., et al.[2021]

In a study of 74 cancer patients, continued smoking after diagnosis was linked to factors such as lower readiness to quit, greater nicotine dependence, and higher emotional distress, which can negatively impact treatment outcomes.

Effective smoking cessation interventions for cancer patients should incorporate pharmacotherapy and counseling that boosts self-efficacy and addresses psychological barriers to quitting, such as fatalistic beliefs and emotional distress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlates of tobacco use among smokers and recent quitters diagnosed with cancer. Schnoll, RA., Malstrom, M., James, C., et al.[2022]

Behavioral treatments for tobacco use are effective and cost-effective, comparable to pharmacotherapies, but have not advanced as quickly in recent years.

There is a need for more research on tobacco cessation interventions specifically for cancer patients, and clinicians are encouraged to use the Five A's approach to support these patients in quitting smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Behavioral tobacco cessation treatments: yesterday's news or tomorrow's headlines? Brandon, TH.[2007]

Individuals with psychiatric disorders show significant deficits in episodic future thinking (EFT), with an overall effect size of g = -0.84, indicating less specific and detailed future event simulations compared to control groups.

Subgroup analyses revealed that these deficits are particularly pronounced in depression, bipolar disorder, and schizophrenia, suggesting that these conditions may impair the ability to mentally simulate future experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Psychopathology and episodic future thinking: A systematic review and meta-analysis of specificity and episodic detail. Hallford, DJ., Austin, DW., Takano, K., et al.[2019]

Episodic future thinking (EFT) significantly reduces delay discounting and cigarette craving among smokers, suggesting it may help in smoking cessation efforts.

Imagining smoking-related illness (SRI) increased delay discounting but also reduced craving, indicating that while SRI can heighten the perceived value of immediate rewards, it may also help in managing cravings when combined with EFT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Episodic Future Thinking about Smoking-Related Illness: A Preliminary Investigation of Effects on Delay Discounting, Cigarette Craving, and Cigarette Demand. Ruhi-Williams, P., King, MJ., Stein, JS., et al.[2022]

A review of smoking cessation interventions from 1999 to 2007 found that methods like individual counseling, group therapy, and nicotine replacement therapy are significantly effective for helping both healthy and sick patients quit smoking.

Medications such as bupropion, nortriptyline, clonidine, and varenicline also showed proven efficacy, while other interventions did not demonstrate effectiveness in aiding smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Smoking cessation with special focus on primary health care]. Bredesen, H., Lous, J.[2019]

In a study involving 71 adult smokers, those who used guided imagery techniques had a significantly higher smoking abstinence rate of 26% after 24 months compared to 12% in the control group.

The intervention included daily practice of guided imagery, suggesting that this mental technique can be an effective tool for long-term smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guided health imagery for smoking cessation and long-term abstinence. Wynd, CA.[2022]

Acceptance and Commitment Therapy (ACT) was found to be feasible and well-accepted among 40 patients with advanced lung cancer, with high attendance (88.75%) and satisfaction rates (95%).

While ACT did not significantly reduce fatigue interference, it showed statistically significant improvements in health-related quality of life, cancer-related fatigue, depressive symptoms, anxiety, and distress, indicating its potential benefits for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Acceptance and Commitment Therapy on fatigue interference and health-related quality of life among patients with advanced lung cancer: A pilot randomized controlled trial. Li, H., Jin, X., Ng, MSN., et al.[2023]

A pilot study involving 18 smokers showed that combining tobacco dependence treatment with lung cancer screening is feasible, with high compliance and follow-up rates.

Participants who received tobacco treatment before lung cancer screening (BCT) had higher quit rates at 4 months (33.3%) compared to those who had screening first (ACT, 22.2%), suggesting that the timing of treatment may influence smoking cessation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot test of a combined tobacco dependence treatment and lung cancer screening program. Ferketich, AK., Otterson, GA., King, M., et al.[2022]

Episodic future thinking (EFT) was successfully applied in a pilot study with 18 individuals seeking treatment for cocaine use disorder, showing that it can help reduce impulsive decision-making by decreasing the discounting of future rewards.

Participants who engaged in EFT by envisioning future positive events demonstrated a significant reduction in discounting behavior compared to standard conditions, indicating that EFT may have therapeutic potential for improving future-oriented decision-making in substance use recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating effects of episodic future thinking on valuation of delayed reward in cocaine use disorder: a pilot study. Forster, SE., Steinhauer, SR., Ortiz, A., et al.[2022]

Episodic future thinking (EFT) shows promise as an intervention for reducing problematic substance use and substance use disorders, based on a systematic review of 16 studies that demonstrated benefits in self-reported and task-based outcomes.

The review highlights the need for further research to assess the feasibility, generalizability, and long-term effects of EFT, as well as to identify factors that influence its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imagining the future can shape the present: A systematic review of the impact of episodic future thinking on substance use outcomes. Collado, A., Stokes, A.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07158749

Generalized and Domain-Specific Episodic Thinking for ... Successful smoking cessation yields the majority of its health benefits (e.g., avoidance of lung cancer) after years of sustained behavioral ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8867367/

Comparing Smoking Cessation Interventions among ... Comparing smoking cessation interventions among underserved patients referred for lung cancer screening: a pragmatic trial protocol.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9223435/

Episodic Future Thinking about Smoking-Related Illness Episodic future thinking (EFT), or mental simulation of future events, has been shown to reduce both delay discounting and laboratory smoking behavior.

4. withpower.com withpower.com/trial/phase-lung-neoplasms-6-2017-9c5be

New Treatment Protocol for Advanced Lung Cancer Episodic future thinking (EFT) has been studied in various contexts, including smoking cessation and substance use disorders, and has shown promising results ...

5. researchgate.net researchgate.net/publication/361239415_Episodic_Future_Thinking_about_Smoking-Related_Illness_A_Preliminary_Investigation_of_Effects_on_Delay_Discounting_Cigarette_Craving_and_Cigarette_Demand

Episodic Future Thinking about Smoking-Related Illness ... Lung Health Study Research Group. The. Effects of a Smoking Cessation Intervention on 14.5-Year Mortality: A Randomized Clinical Trial. Ann ...

6. mdpi.com mdpi.com/1660-4601/19/12/7136

Episodic Future Thinking about Smoking-Related Illness In this preliminary investigation, we examined the effects of EFT specifically about smoking-related illness (SRI) on delay discounting, cigarette craving, and ...