New Treatment Protocol for Advanced Lung Cancer
(BLCIO Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Ohio State University Comprehensive Cancer Center
Disqualifiers: Chemoradiotherapy, Surgery, Advanced treatment, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial tests new ways to treat advanced lung cancer using genetic and immune system tests, along with expert advice for doctors. It aims to improve survival and quality of life for patients with stage IV non-small cell lung cancer.
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 data supports the effectiveness of the treatment Smoking Cessation Intervention, Episodic Future Thinking (EFT), Smoking Cessation Intervention for advanced lung cancer?
Research shows that behavioral treatments, like smoking cessation interventions, are effective and cost-efficient for helping people quit smoking. These treatments are especially important for cancer patients, as quitting smoking can improve survival rates and treatment outcomes. Additionally, psychological interventions have been shown to enhance the effectiveness of nicotine replacement therapies, suggesting that combining these approaches could be beneficial.
12345Is the new treatment protocol for advanced lung cancer, which includes episodic future thinking, safe for humans?
Episodic future thinking (EFT) has been studied in various contexts, including smoking cessation and substance use disorders, and has shown promising results without any reported safety concerns in humans.
678910How does the new treatment for advanced lung cancer differ from existing options?
The new treatment for advanced lung cancer involves Acceptance and Commitment Therapy (ACT), which is unique because it focuses on improving quality of life and managing fatigue through psychological techniques rather than traditional medical approaches. This therapy uses personal values and experiential exercises to help patients cope with their condition, which is different from standard drug treatments.
311121314Eligibility Criteria
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
+3 more
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.
Trial Timeline
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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (AGIT/DS)Experimental Treatment6 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 Control7 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ohio State University Comprehensive Cancer CenterColumbus, OH
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Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer CenterLead Sponsor
References
Behavioral tobacco cessation treatments: yesterday's news or tomorrow's headlines? [2007]This article reviews behavioral treatments (broadly defined) for tobacco use, discusses cessation treatments for cancer patients, and predicts the future direction of behavioral interventions. During the past decade, progress in behavioral treatments for tobacco use has not kept pace with progress made in the development of pharmacotherapies. Nevertheless, the efficacy and cost-effectiveness of behavioral treatments compare favorably with the pharmacotherapies. Intensive behavioral interventions with empirical support are reviewed, and the difficulty of attracting smokers to intensive smoking clinics is discussed. Because there has been little research on tobacco cessation interventions designed specifically for cancer patients, clinicians should follow the Five A's suggested in the recent Clinical Practice Guidelines: Ask, Advise, Assess, Assist, and Arrange. The future of behavioral treatments will likely emphasize both minimal interventions (via telephone, Internet, and written materials) designed for broad impact and intensive interventions targeted to particular subgroups of smokers with the need and motivation for them (eg, the heavily nicotine-dependent, pregnant women, depression-prone smokers, and medical patients). A blurring of the distinctions between behavioral interventions, pharmacotherapies, and community-oriented approaches is also likely as multidimensional cessation strategies are developed.
Psychological interventions: state of the art. [2019]The usefulness of psychological interventions in smoking cessation is well established. Ongoing efforts are aimed at establishing interventions for specific diagnostic groups, developing interventions that are targeted at smokers who do not seek treatment, and combining psychological and pharmacological treatment. There is emerging evidence that useful treatments have been developed for smokers with a depression history, and that expert system interventions based upon a stage model can be useful in changing the smoking behavior of smokers who are not yet ready to quit. Psychological interventions add to the efficacy of nicotine replacement therapy, but whether they add to the efficacy of other pharmacotherapies is not known. There is a need to determine whether psychological interventions are useful for diagnostic groups other than depressive disorder, and if so, whether they need be specific for that group. Additional research is needed on interventions for smokers who are not ready to quit, both in developing new techniques, and determining the need and usefulness of adaptations of those in existence to specific populations.
Correlates of tobacco use among smokers and recent quitters diagnosed with cancer. [2022]Smoking after a cancer diagnosis shortens survival time, increases risk of recurrence and the development of another primary tumor, reduces treatment efficacy, and increases treatment complications. Nevertheless, many patients who smoked prior to their illness continue to smoke after diagnosis and treatment. The development of effective smoking cessation interventions for cancer patients has been slowed by the lack of data concerning psychological correlates of smoking in this population. This study, with 74 cancer patients, showed that smoking and lower readiness to quit was associated with: having relatives at home who smoke, a longer time between diagnosis and assessment, completion of medical treatment, greater nicotine dependence, lower self-efficacy, quitting pros, and risk perceptions, and higher quitting cons, fatalistic beliefs, and emotional distress. Thus, smoking cessation treatments for cancer patients should include pharmacotherapy, relapse prevention, and counseling designed to facilitate self-efficacy, quitting pros, and risk awareness and to reduce the quitting cons, fatalism, and distress.
[Smoking cessation with special focus on primary health care]. [2019]This review gives a presentation of current smoking cessation interventions, based on data collected from The Cochrane Library and randomized trials found in the PubMed database 1999-2007. The review investigates the effect of smoking cessation interventions in healthy and sick patients and the use of such interventions in daily practice. Individual counselling, group therapy, self-help materials and proactive telephone counselling all have a proven significant effect, as has nicotine replacement therapy, bupropion, nortryptyline, clonidine and vareniclin. Other interventions are without demonstrated effectiveness.
Guided health imagery for smoking cessation and long-term abstinence. [2022]To examine the effectiveness of guided imagery for immediate smoking cessation and long-term abstinence in adult smokers.
Imagining the future can shape the present: A systematic review of the impact of episodic future thinking on substance use outcomes. [2023]The combination of the high prevalence of problematic substance use and substance use disorders (SUD) with the low rates of spontaneous remission continues to generate interest in the development of novel and efficacious interventions. Theoretically, episodic future thinking (EFT) is capable of targeting various underlying psychological and neurobiological substrates of SUD by traversing various research domain criteria systems.
Episodic Future Thinking about Smoking-Related Illness: A Preliminary Investigation of Effects on Delay Discounting, Cigarette Craving, and Cigarette Demand. [2022]Cigarette smokers show excessive delay discounting (devaluation of delayed rewards), which may contribute to tobacco use disorder. Episodic future thinking (EFT), or mental simulation of future events, has been shown to reduce both delay discounting and laboratory smoking behavior. Traditionally, EFT involves vividly imagining positive future events. In this preliminary investigation, we examined the effects of EFT specifically about smoking-related illness (SRI) on delay discounting, cigarette craving, and behavioral economic demand for cigarettes. In a 2 (episodic thinking) × 2 (smoking-related illness) factorial design, we randomly assigned smokers from Amazon Mechanical Turk to one of two EFT groups: EFT alone or EFT + SRI; or one of two episodic "recent" thinking (ERT) control groups: ERT alone or ERT + SRI. Both EFT groups generated and imagined positive future events, while both ERT groups imagined real events from the recent past. Both EFT + SRI and ERT + SRI groups imagined these events while also experiencing SRI symptoms. Participants then completed assessments of delay discounting, cigarette craving, and measures of cigarette demand. We observed significant main effects on delay discounting of both EFT (reduced discounting) and SRI (increased discounting), as well as significant main effects of both EFT and SRI on cigarette craving (in both cases, reduced craving). No significant main effect of EFT was observed on cigarette demand measures, although we observed a main effect of SRI on quantity of demand when cigarettes were free (Q0) (reduced demand). In all analyses, we observed no significant EFT × SRT interactions, indicating that these variables operate independently of one another. These methods may be adapted for use in clinical treatment to aid in smoking cessation interventions.
Episodic future thinking for smoking cessation in individuals with substance use disorder: Treatment feasibility and acceptability. [2021]Smokers with substance use disorders (SUD) smoke approximately four times more than the general population. Current efforts are focused on improving smoking cessation treatments for this population. Episodic future thinking (EFT), a novel intervention aimed at decreasing impulsive choice, has shown promising results for reducing cigarette demand in experimental settings. This feasibility study sought to examine the feasibility and preliminary EFT effects on delay discounting (DD) and nicotine intake reductions throughout treatment.
Psychopathology and episodic future thinking: A systematic review and meta-analysis of specificity and episodic detail. [2019]Episodic future thinking (EFT) refers to the mental simulation of future events that might be personally-experienced; a crucial mental process in adaptation. Psychiatric disorders are associated with deficits in recalling episodic memory, however, no study has reviewed the empirical literature to assess for similar deficits in EFT. A systematic review comparing psychiatric groups with control groups on the specificity and episodic detail of EFT returned 19 eligible studies. An overall effect of g = -0.84 (95%CI = -1.06, - 0.62, p
Evaluating effects of episodic future thinking on valuation of delayed reward in cocaine use disorder: a pilot study. [2022]Background: Episodic future thinking (EFT; i.e., envisioning oneself in future contexts) has been demonstrated to reduce discounting of future reward in healthy adults. While this approach has the potential to support future-oriented decision-making in substance use recovery, the impact of EFT on discounting behavior in illicit stimulant users has not yet been evaluated.Objectives: This pilot study aimed to (1) assess the feasibility of utilizing EFT methods in individuals with cocaine use disorder (CUD) and (2) conduct preliminary measurement of the EFT effect on discounting behavior in this population.Methods: Eighteen treatment-seeking individuals with CUD (17 males) were interviewed about positive and neutral events expected to occur at a range of future latencies. Future event information identified by participants was subsequently included on a subset of trials in an intertemporal choice task to promote EFT; within-subject differences in discounting between standard and EFT conditions were evaluated.Results: Participants identified relevant events and demonstrated decreased discounting of future reward when event descriptors were included (relative to discounting without event descriptors; p = .039). It was further noted that most events identified by participants were goals, rather than plans or significant dates.Conclusion: While methods previously used to study the effect of EFT on discounting behavior in healthy individuals are also effective in individuals with CUD, methodological factors - including types of events identified - should be carefully considered in future work. These preliminary findings suggest that EFT can reduce impulsive decision-making in cocaine use disorder and may therefore have therapeutic value.
Acceptance and commitment therapy for smoking cessation: a preliminary study of its effectiveness in comparison with cognitive behavioral therapy. [2022]This controlled preliminary trial determined the feasibility and initial effectiveness of a promising behavioral intervention for smoking: Acceptance and Commitment Therapy (ACT). In a quasi-experimental design, the ACT intervention condition used metaphors and experiential exercises focused on personal values to motivate quitting smoking and enhancing the willingness to experience internal cues to smoke (e.g., urges) and abstinence-related internal distress. The comparison condition was cognitive behavioral therapy (CBT)--the current standard in behavioral intervention for smoking cessation. Each treatment was delivered in seven weekly 90-min sessions in a group format to 81 (43 in ACT; 38 in CBT) adult smokers. Results show that the ACT treatment was as feasible as the CBT treatment. They also demonstrate promising evidence of ACT's effectiveness: 30.2% intent-to-treat biochemically-supported 30-day point prevalence at twelve month follow-up, compared with 13.2% in the CBT condition (odds ratio = 5.13; p = .02). Replication in a well-powered, randomized, controlled trial is now needed.
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. [2022]Even though survival and quality of life are adversely affected by smoking among cancer patients, about one-third of cancer patients who smoked prior to their diagnosis continue to smoke. One barrier to the provision of smoking cessation treatments to cancer patients is the paucity of data on the characteristics of cancer patients who continue to smoke and a lack of data on correlates of quit motivation in this population. This descriptive study assessed demographic, medical, smoking history, and psychological characteristics of cancer patients in a smoking cessation program (N=111) and examined these characteristics as correlates of quit motivation. Methods used by patients to quit smoking were also queried. We found that: (1) most patients are Caucasian, married, diagnosed with head and neck (versus lung) cancer, highly addicted to nicotine, and in the contemplation or preparation stage of change; (2) most patients attempt to quit smoking without formal treatment, although 33-50% have used the transdermal nicotine patch, nicotine gum, or bupropion; (3) depressive symptoms, low quitting self-efficacy, low perceived risk, and low perceived benefits of quitting are prevalent among patients, but most patients do not endorse the perceived disadvantages of quitting or fatalistic beliefs; and (4) quit motivation is associated with higher quitting self-efficacy, risk perceptions, and perceived benefits of quitting, lower tobacco use and nicotine addiction, and shorter time since diagnosis. These findings can help guide the development of smoking cessation interventions for cancer patients.
A pilot test of a combined tobacco dependence treatment and lung cancer screening program. [2022]Lung cancer screening with computed tomography has demonstrated a significant reduction in mortality. While these findings are important for the lung cancer research field, the most important risk factor for lung cancer, i.e. smoking, should not be ignored. We performed a pilot study to examine the feasibility of delivering a program that included both tobacco dependence treatment and lung cancer screening. The objectives of this study were to: (1) estimate the proportion of smokers who complied with a 12-week treatment protocol that included both tobacco dependence treatment and lung cancer screening, (2) obtain preliminary estimates of abstinence and quit attempts at 4 and 6 months, and (3) obtain preliminary estimates of the cognitive social health information processing (C-SHIP) constructs and how they change following the intervention. In this randomized pilot study, 18 volunteers completed a 12-week protocol: half received the tobacco dependence treatment program before a CT scan (BCT) and the other received the CT scan first, followed by the treatment program (ACT). The treatment protocol included both nurse-delivered telephone counseling and either nicotine replacement therapy or varenicline. Only one person did not complete all follow-up evaluations. At 4 months post enrollment, the carbon monoxide confirmed quit rates were 33.3% in the BCT arm and 22.2% in the ACT arm (27.8% overall), and all but one had made a 24-h attempt to quit. At 6 months the confirmed abstinence decreased to 22.1% in the BCT arm and 11.1% in the ACT arm (16.7% overall), and 72.2% of participants had made a 24-h quit attempt. These preliminary results suggest that it might be better to deliver treatment before the screening test. Future randomized trials with a larger sample size are needed to confirm these findings.
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. [2023]The present study aimed to examine the feasibility and preliminary effects of Acceptance and Commitment Therapy (ACT) on fatigue interference and health-related quality of life in patients with advanced lung cancer.