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

Trial Summary

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 data supports the effectiveness of the treatment CONNECTing to LungCare for smoking cessation in lung cancer patients?

Research shows that proactive telephone counseling combined with self-directed interventions can be more effective in helping people quit smoking. Additionally, a study found that telephone-based counseling in lung cancer screening settings led to higher quit rates compared to usual care. ^{1 2 3 4 5}

Is the Smoking Cessation Program for Lung Cancer generally safe for humans?

The safety data for treatments related to lung cancer, such as antifibrotic drugs and targeted therapies, show that they can have adverse effects like interstitial lung disease (lung inflammation) and other toxicities. However, these treatments are generally considered safe when monitored properly, and patients often receive support to manage side effects. ^{6 7 8 9 10}

How does this smoking cessation treatment for lung cancer differ from other treatments?

This smoking cessation treatment is unique because it combines proactive telephone counseling with a tailored self-directed intervention, which may be more effective than self-directed efforts alone. It also emphasizes integrating smoking cessation services into multidisciplinary lung cancer care, providing a comprehensive approach that is not consistently implemented in oncology practices. ^{1 3 11 12 13}

What is the purpose of this trial?

This study evaluates a smoking cessation intervention (CONNECTing to LungCare) for improving shared decision-making conversations about smoking cessation and lung cancer screening between patients and providers. Shared decision making is a patient care model in which providers offer information regarding risks and benefits, patients express their values and preferences, and then healthcare decisions are jointly discussed between the patient and provider. Patient education, aided by decision support tools, can increase patients' knowledge, decrease their decisional conflict, promote decision making, and improve the patients' perception of risk. CONNECTing to LungCare is an interactive education intervention that addresses lung cancer screening and smoking cessation and provides participants with a tailored summary that may make them more likely to have shared decision-making discussions with their providers about smoking cessation and lung cancer screening.

Research Team

Judith Walsh-Cassidy, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Assessment of the impact of adjunctive proactive telephone counseling to promote smoking cessation among lung cancer patients' social networks. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Surgical lung cancer patients' views about smoking and support to quit after diagnosis: a qualitative study. [2022]

3. China pubmed.ncbi.nlm.nih.gov

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

4. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Improving coordination of lung cancer care at a tertiary healthcare center in Saudi Arabia. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of a telephone-based smoking cessation intervention in the lung cancer screening setting: A randomized clinical trial. [2019]

6. United States 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. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Discovering Associations of Adverse Events with Pharmacotherapy in Patients with Non-Small Cell Lung Cancer Using Modified Apriori Algorithm. [2022]

8. United States 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. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

IPF Care: a support program for patients with idiopathic pulmonary fibrosis treated with pirfenidone in Europe. [2018]

10. Switzerland 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. [2023]

11. China pubmed.ncbi.nlm.nih.gov

Integration of smoking cessation and lung cancer screening. [2023]

12. United States pubmed.ncbi.nlm.nih.gov

A Randomized Controlled Study of Integrated Smoking Cessation in a Lung Cancer Screening Program. [2020]

13. United States pubmed.ncbi.nlm.nih.gov

Importance of Smoking Cessation in a Lung Cancer Screening Program. [2021]