Smoking Cessation Program for Lung Cancer

Overseen By Van Le

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Not a current smoker

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

Compensation: Varies

Number of Visits: Unknown

147 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new program called CONNECTing to LungCare, designed to improve conversations between smokers or lung cancer screening candidates and their doctors about quitting smoking. The program offers personalized education and tools to promote shared decision-making, enabling patients and doctors to discuss and decide on the best steps together. It includes interactive sessions, video segments, and follow-up support to help participants understand the risks and benefits of quitting smoking and screening for lung cancer. Smokers or those eligible for lung cancer screening who visit a participating clinic may be suitable for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative approaches in patient-doctor communication and decision-making.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the CONNECTing to LungCare intervention is safe?

Research shows that the CONNECTing to LungCare program helps people discuss quitting smoking and lung cancer screening with their doctors. The program information mentions no safety concerns. As an educational initiative rather than a medication or medical procedure, it is likely safe. Participants watch videos and receive personalized feedback, which is generally safe. Additionally, other studies have used similar tools to aid smoking cessation without reports of harm. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the CONNECTing to LungCare program because it offers a personalized approach to smoking cessation, which is different from standard care options like counseling and nicotine replacement therapy. This program uniquely integrates computerized assessments and tailored video content to address individual concerns and barriers, enhancing motivation for quitting smoking. Additionally, it supports shared decision-making by providing both patients and their healthcare providers with a detailed summary of these concerns, thus fostering a more collaborative effort in the quitting process. The program also includes follow-up calls and text messages that keep participants engaged and supported, potentially leading to more successful smoking cessation outcomes.

What evidence suggests that the CONNECTing to LungCare intervention is effective for smoking cessation and lung cancer screening?

Research shows that programs to help people stop smoking can be effective. In this trial, participants may receive the CONNECTing to LungCare intervention, which significantly reduces cigarette use. One study found that 14.3% of participants quit smoking after three months, and 10.3% remained smoke-free after six months. These results are encouraging because they suggest that using educational tools and making decisions together can help people quit smoking, which is important for those at risk of lung cancer. Additionally, combining smoking cessation with lung cancer screening can greatly lower the chances of dying from lung cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Judith Walsh-Cassidy, MD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for individuals interested in quitting smoking and learning about lung cancer screening. Participants should be willing to engage in shared decision-making with their healthcare providers, using an educational intervention called CONNECTing to LungCare.

Inclusion Criteria

Must be current smokers and/or candidates for Lung Cancer Screening (LCS)

Primary care patients at the University of California, San Francisco (UCSF) General Internal Medicine (GIM) clinics

Exclusion Criteria

Not a current smoker

Must be working in one of the clinics participating in CONNECTing to LungCare

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Beta Testing

Participants interact with the CONNECTing to LungCare intervention and provide feedback in support of intervention refinement.

4 weeks

Feasibility Trial

Participants receive the CONNECTing to LungCare intervention, including education about the benefits and risks of LCS and the importance of shared decision making, computerized assessments, and tailored video segments.

Up to 1 year

Follow-up

Participants are monitored for shared decision-making conversations and smoking cessation outcomes through follow-up phone calls and EHR reviews.

3 months

What Are the Treatments Tested in This Trial?

Interventions

• CONNECTing to LungCare

Trial Overview The study tests a program designed to help patients quit smoking and make informed decisions about lung cancer screening. It involves collecting saliva samples, completing surveys, and participating in the CONNECTing to LungCare education intervention.

How Is the Trial Designed?

Group I: Feasibility trial, Group I (CONNECTing to LungCare) Experimental Treatment 3 Interventions

Participants receive the CONNECTing to LungCare intervention, including education about the benefits and risks of LCS and the importance of shared decision making, computerized assessments of the participant's smoking status, readiness to quit and concerns about quitting, and video segments tailored to the participant's responses to assessment questions, prior to their primary care appointment. Participants and their providers receive a tailored summary of the participant's concerns and barriers to quitting to enhance motivation for smoking cessation and shared decision-making discussions. Participants then receive up to 3 follow-up phone calls over 10-15 minutes each encouraging them to follow up with their provider, to complete the shared decision-making conversation, obtain LCS if appropriate, and access smoking cessation resources. Participants may also receive brief, tailored follow-up text messages that include links to video segments or cessation resources 1-3 times weekly.

Group II: Beta testing (CONNECTing to LungCare, feedback) Experimental Treatment 2 Interventions

Participants interact with the CONNECTing to LungCare intervention and provide feedback in support of intervention refinement.

Group III: Feasibility trial, Group II (usual care) Active Control 3 Interventions

Participants receive usual care from their provider at their primary care appointment.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

Tobacco Related Disease Research Program

Collaborator

Trials

27

Recruited

26,300+

Alere San Diego

Industry Sponsor

Trials

10

Recruited

6,000+

Published Research Related to This Trial

In a study of 16,527 non-small cell lung cancer patients, the most common adverse events linked to pharmacotherapy were hypocalcemia, elevated creatine phosphokinase, and hypertriglyceridemia, highlighting the need for monitoring these conditions during treatment.

The modified Apriori algorithm proved to be more effective than the conventional method in identifying associations between chemotherapy drugs and adverse events, suggesting it could be a valuable tool for improving patient safety in cancer pharmacotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovering Associations of Adverse Events with Pharmacotherapy in Patients with Non-Small Cell Lung Cancer Using Modified Apriori Algorithm. Chen, W., Yang, J., Wang, HL., et al.[2022]

A randomized controlled trial involving 496 participants (245 in the proactive counseling group and 251 in the control group) found that proactive telephone counseling did not significantly improve smoking cessation rates overall, but younger participants (<50 years) showed a higher cessation rate at 2 weeks (16% vs. 4%).

The study suggests that while proactive counseling aimed at teaching coping skills was challenging to implement, it may still hold potential for younger smokers in the social networks of lung cancer patients, indicating a need for further research to optimize such interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks. Bastian, LA., Fish, LJ., Peterson, BL., et al.[2022]

Tobacco use is the leading cause of lung cancer, yet many patients continue to smoke even after diagnosis, highlighting the need for effective smoking cessation interventions in oncology settings.

Multidisciplinary lung cancer treatment programs are well-suited to provide comprehensive tobacco treatment services, but current implementation of these services is often inconsistent and inadequate, suggesting a need for improved delivery strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of tobacco cessation services into multidisciplinary lung cancer care: rationale, state of the art, and future directions. Warren, GW., Ward, KD.[2022]

In a study of 60 lung cancer patients, the coordination of care through a multidisciplinary tumor board (MTB) positively influenced patient management in 35% of cases, highlighting the importance of collaborative decision-making in cancer treatment.

A significant portion of patients (76.2%) with stage IV lung cancer were referred to palliative care, indicating a strong focus on improving quality of life for advanced cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving coordination of lung cancer care at a tertiary healthcare center in Saudi Arabia. Alkhathlan, A., Alfaiz, R., Almusallam, G., et al.[2022]

The National Lung Screening Trial showed that low-dose computed tomography (LDCT) significantly reduces lung cancer mortality and overall mortality in high-risk individuals aged 55-74 with a history of heavy smoking (30 pack-years).

Integrating smoking cessation resources into lung cancer screening programs is crucial, as it not only helps reduce lung cancer risk but also addresses other smoking-related diseases, ultimately aiming to improve the overall health and longevity of screened patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of smoking cessation and lung cancer screening. Steliga, MA., Yang, P.[2023]

A randomized control trial involving 345 active smokers undergoing lung cancer screening found that intensive telephone-based smoking cessation counseling did not significantly increase 12-month quit rates compared to usual care, with only a 1.4% difference in abstinence rates.

The study suggests that routine referral to counseling for smoking cessation in lung cancer screening programs may not be effective, indicating a need for future research to identify better methods for helping older, long-term smokers quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Study of Integrated Smoking Cessation in a Lung Cancer Screening Program. Tremblay, A., Taghizadeh, N., Huang, J., et al.[2020]

This study analyzed data from the Japanese Adverse Drug Event Report (JADER) and the FDA Adverse Event Reporting System (FAERS) to investigate the incidence of interstitial lung disease (ILD) potentially caused by antifibrotic drugs nintedanib and pirfenidone, both of which are first-line treatments for idiopathic pulmonary fibrosis (IPF).

The findings indicated that both nintedanib and pirfenidone were associated with signals for causing ILD, emphasizing the need for careful monitoring of these drugs due to their limited effectiveness and potential to induce lung damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the potential complication of interstitial lung disease associated with antifibrotic drugs using data from databases reporting spontaneous adverse effects. Nawa, H., Hamano, H., Niimura, T., et al.[2023]

In a study of 1361 patients undergoing radiation therapy for locally advanced lung cancer, over half (53%) reported significant declines in their quality of life (QoL) by the end of treatment, indicating that treatment can have a substantial impact on patient well-being.

While clinician-reported adverse events (AEs) were linked to declines in QoL, the correlation was only moderate, suggesting that patient-reported outcomes (PROs) are crucial for understanding the full impact of treatment and may help identify when interventions are needed to improve patient experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between Physician- and Patient-Reported Symptoms in Patients Treated With Definitive Radiation Therapy for Locally Advanced Lung Cancer in a Statewide Consortium. Wilkie, JR., Hochstedler, KA., Schipper, MJ., et al.[2022]

Surgical lung cancer patients often attempt to quit smoking during hospitalization, but many relapse shortly after discharge, indicating a need for ongoing support.

Most patients expressed a desire for smoking cessation support integrated into their cancer care, highlighting that they would welcome help from health professionals to quit smoking, especially in the weeks following surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Surgical lung cancer patients' views about smoking and support to quit after diagnosis: a qualitative study. Farley, A., Aveyard, P., Kerr, A., et al.[2022]

A pilot randomized trial involving 92 current smokers (average age 60.2 years) showed that telephone counseling (TC) for smoking cessation significantly increased quit rates to 17.4% compared to 4.3% in the usual care group, indicating the efficacy of TC in a lung cancer screening (LCS) setting.

The study demonstrated that TC is a feasible intervention, with participants completing an average of 4.4 counseling sessions, suggesting that integrating such programs into LCS could enhance public health efforts to reduce smoking among high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of a telephone-based smoking cessation intervention in the lung cancer screening setting: A randomized clinical trial. Taylor, KL., Hagerman, CJ., Luta, G., et al.[2019]

Lung cancer screening programs can potentially enhance smoking cessation efforts, as studies have shown changes in smoking behavior among participants in major screening trials in the U.S. and Europe.

Understanding the relationship between smoking habits and surgical outcomes can help improve post-diagnosis and post-treatment smoking cessation strategies, maximizing the overall benefits of lung cancer screening and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Importance of Smoking Cessation in a Lung Cancer Screening Program. Munshi, V., McMahon, P.[2021]

The IPF Care Patient Support Program provides essential support and education to patients with idiopathic pulmonary fibrosis (IPF) receiving pirfenidone, leading to high patient satisfaction and low discontinuation rates from the program.

Patients in the IPF Care program often require dose modifications due to adverse events, which typically occur early in treatment, but most continue on a stable maintenance dose, indicating effective management of side effects through the program's support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IPF Care: a support program for patients with idiopathic pulmonary fibrosis treated with pirfenidone in Europe. Duck, A., Pigram, L., Errhalt, P., et al.[2018]

Targeted therapies for non-small cell lung cancer (NSCLC) have significantly improved treatment options, but their effectiveness can be compromised by issues like poor patient adherence and adverse events.

The review highlights the need for standardized monitoring protocols for the various toxicities associated with these therapies, which can include skin, gastrointestinal, lung, and heart-related side effects, to ensure better patient management and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeted Toxicities: Protocols for Monitoring the Adverse Events of Targeted Therapies Used in the Treatment of Non-Small Cell Lung Cancer. Hines, JB., Bowar, B., Levine, E., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7641238/

Clinical impact and cost-effectiveness of integrating ... This study aimed to assess the impact of adding a smoking cessation intervention to lung cancer screening on clinical outcomes, costs and cost-effectiveness.

2. withpower.com withpower.com/trial/phase-cigarette-smoking-related-carcinoma-5-2024-c1c53

Smoking Cessation Program for Lung Cancer This study evaluates a smoking cessation intervention (CONNECTing to LungCare) for improving shared decision-making conversations about smoking cessation ...

3. ascopubs.org ascopubs.org/doi/10.1200/OP.2024.20.10_suppl.357

Efficacy of a smoking cessation program for patients with ... Conclusions: Our smoking cessation program demonstrates effectiveness in facilitating a significant decrease in PPD. However, low utilization ...

4. jto.org jto.org/article/S1556-0864(25)00175-3/fulltext

Reducing Lung Cancer Mortality by Providing Smoking ... SCS delivered in the LCS setting can considerably reduce lung cancer mortality, with the potential to reduce global, racial, economic, and geographic ...

5. ilcn.org ilcn.org/smoking-cessation-in-lung-cancer-screening-the-latest-randomized-controlled-trial-evidence/

Smoking Cessation in Lung Cancer Screening ⁸ Cessation rates of 14.3% at 3 months and 10.3% at 6 months are encouraging given that 48% of participants in the trial were not yet ready to ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06213532

Study Details | NCT06213532 | CONNECTing to LungCare This study evaluates a smoking cessation intervention (CONNECTing to LungCare) for improving shared decision-making conversations about smoking cessation ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4828323/

Pairing Smoking-Cessation Services With Lung Cancer ... A pilot study of a 12-week smoking-cessation program for lung cancer screening participants (N = 18) yielded more promising results. In that trial, half of ...

8. ancora.ai ancora.ai/it/details/NCT06213532

CONNECTing to LungCare (NCT06213532) This study evaluates a smoking cessation intervention (CONNECTing to LungCare) for improving shared decision-making conversations about smoking cessation ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03611881

Assessing the Integration of Tobacco Cessation Treatment ... This randomized controlled trial seeks to evaluate the effectiveness of alternative strategies to integrate smoking cessation interventions into the ...