Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Lung Neoplasms

Subjects at high risk of lung cancer screened by the medical team of the AOUPR or by GPs to join the prevention program.

Inclusion criteria

* Age between 50 and 75 years
* Equivalent tobacco intoxication of ≥ 15 cigarettes per day for ≥25 years or ≥ 10 cigarettes per day for ≥30 years
* Status of current smoker or ex-smoker for \<10 years.

Exclusion criteria

• Personal history of cancer within the prior 5 years

Early detection of lung cancer by LDCT and smoking cessation counselling

Low-dose computed tomography (LDCT)

Nicola Sverzellati, MD, PhD

This project from the University Hospital of Parma (AOUPR) aims to verify the feasibility of a prevention program in our district, relying on advanced technological resources and highly experienced team in lung cancer early diagnosis, in order to identify useful elements towards the applicability of such a prevention program on a large scale (regional, national).

Uncontrolled, monocentric experimental study with dynamic enrollment and prospective data collection, aimed at implementing a prevention program based on scientific evidence. This study is set to verify the applicability and feasibility of a lung cancer prevention program in a real context, including a preliminary evaluation at the smoking cessation clinic and a LDCT assessment with subsequent LDCT follow-up for participants who show indeterminate findings at the first LDCT (LDCT baseline) exam.

The main objective of the study is to verify the feasibility of a lung cancer prevention program according to internationally validated scientific methods.

Secondary objectives:

1. To evaluate the use of local smoking cessation clinics and their effects in terms of smoking cessation (primary prevention)
2. To evaluate the outcomes of the program in terms of number of patients with early (presymptomatic) lung cancer treated with minimally invasive surgery (secondary prevention)
3. To evaluate the number of false positives and their diagnostic work-up (PET-CT, CT-guided biopsy, bronchoscopy)

Primary endpoint:

- Percentage of enrolled subjects to whom the program was offered within 60 days from the date of enrolment and percentage of those who stop smoking for at least 12 months

Secondary endpoints:

* To describe the organizational model, human resources employed, difficulties encountered and elements that have favoured its realization
* To measure the variation in smoking habits in enrolled smokers
* To describe the effect of annual LDCT on lung cancer diagnosis rates, considering size, shape, histology and site
* To measure the consequent demand for further diagnostic investigations and treatment
* To measure the number of false positives

Subjects at high risk of lung cancer screened by the medical team of the AOUPR or by GPs to join the prevention program.

Inclusion criteria

* Age between 50 and 75 years
* Equivalent tobacco intoxication of ≥ 15 cigarettes per day for ≥25 years or ≥ 10 cigarettes per day for ≥30 years
* Status of current smoker or ex-smoker for \<10 years.

Exclusion criteria

• Personal history of cancer within the prior 5 years

We expect to recruit around 500 people in 1 year. This sample size is considered adequate based on the available resources, both human and economic.

After closing and adjusting the database and before data analysis, a document called Statistical Analysis Plan (SAP) will be drawn up. It will consist of the following paragraphs:

* Statistical methods planned in the study protocol;
* Size of the sample;
* Management of missing data;
* Evaluation of the endpoints;
* Statistical models that will be applied in the analysis. The socio-demographic characteristics of the enrolled subjects, the adopted organizational methods and the effects of the prevention program (endpoints) will be analyzed and described using tables and figures.

The project "PRogetto Salute Parma: Primary and secondary prevention of smoking-related lung cancer" will be started once approved by the institutional Ethics Committee and authorized by the General Manager. The study is expected to be carried out over 2 years (from the inclusion of the first subject), with an expected period of 1 year for the enrolment and 1 further year for follow-up.

PRogetto Salute Parma

PRogetto Salute Parma: PRevenzione Primaria e Secondaria Del Danno da Fumo

Percentage of enrolled subjects to whom the program was offered within 60 days from the date of enrolment and percentage of those who stop smoking for at least 12 months

To describe the organizational model, human resources employed, difficulties encountered and elements that have favoured its realization

To measure the variation in smoking habits in enrolled smokers.

To describe the effect of annual LDCT on lung cancer diagnosis rates, considering size, shape, histology and site.

To measure the demand for further diagnostic investigations and treatment generated by LDCT.

To measure the number of false positives generated by LDCT

Azienda Ospedaliero-Universitaria di Parma

Azienda Unità Sanitaria Locale (AUSL) di Parma

University of Parma

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

This arm provides a multi-faceted, 8-session intensive telephone counseling (ITC) protocol, tailored on lung cancer screening results, with 8-weeks of free nicotine replacement patches provided (Nicoderm patch, 21mg, 14mg, and 7mg) and primary care engagement.

This arm provides a multi-faceted, 3-session usual care telephone counseling (UC) protocol, with 2-weeks of free nicotine replacement patches provided (Nicoderm patch, 21mg, 14mg, and 7mg) and primary care engagement.

Participants are provided up to 8 counseling sessions lasting approximately 20 minutes each and access to 8-weeks of free nicotine replacement patches. A counselor-initiated discussion of screening results will also be included throughout the counseling sessions.

Intensive Telephone Counseling (8 sessions) with nicotine replacement

Participants are provided up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine replacement patches.

Usual Care: Telephone counseling (3 sessions) with nicotine replacement

The purpose of this study is to compare intensive telephone counseling (ITC) plus the nicotine patch vs. standard telephone counseling plus the nicotine patch (Usual Care; UC) among current smokers undergoing lung cancer screening. Smoking-related outcomes will be examined at three, six and twelve months post-randomization.

The investigators have built on the evidence-base of telephone counseling for smoking cessation. This pragmatic approach is designed at the intersection of scalability and intensity, for future implementation within the national tobacco quitline. In collaboration with five geographically and ethnically diverse lung cancer screening programs, the investigators will accrue smokers who have registered for screening,and are at all levels of readiness to quit. Prior to the screening day, the investigators will conduct the baseline (T0) phone interview. Following participants' receipt of their screening result (one week post-screening), the investigators will complete the T1 phone interview, provide brief advice to quit and conduct randomization. Participants will be randomized into one of two groups: ITC, in which participants are provided up to 8 counseling sessions lasting approximately 20 minutes each and access to 8-weeks of free nicotine patches. ITC will include a discussion of screening results throughout counseling sessions. The UC arm will include up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine patches. UC will not include a discussion of screening results throughout counseling sessions. All sessions will be conducted by a Tobacco Treatment Specialist (English or Spanish) and the investigators will assess intervention fidelity. In both groups, the investigators will engage referring physicians by notifying them of their patients' study enrollment and of their patients' smoking status at the 6-month follow-up. The 3-month (T2), 6-month (T3), and 12-month (T4) assessments will assess readiness to quit, quit attempts, 7-day and 30-day abstinence verified by Nicalert or carbon monoxide testing, and intervention process variables. Furthermore, two important aspects of this approach include a cost-effectiveness analysis and use of the Cancer Intervention and Surveillance Modeling Network (CISNET) to evaluate the cost of the interventions relative to their impact on short- and long-term smoking-related outcomes.

The aims are:

1. To compare ITC vs. UC standard telephone counseling. H1.1. At 3-, 6-, and 12- months, the ITC arm will have significantly improved biochemically verified 7-day and 30-day abstinence, compared to UC. H1.2. Mediators, including teachable moment factors (e.g., perceived risk based on screening results) and process measures (TC and nicotine patch adherence, primary care appointment) will positively affect cessation outcomes at 3-, 6- and 12-months. H.1.3. Moderators include screening result, readiness to quit, and nicotine dependence.
2. To evaluate reach (% of current smokers enrolled) and engagement (% who receive the interventions), both overall and among subgroups (gender, age, nicotine dependence, site). The investigators will assess intervention fidelity and feasibility for implementation, from both community-based and academically-based screening centers.
3. To conduct an economic analysis to test the hypothesis that while costlier, ITC will be more effective and have greater reach than UC in the lung screening setting, making it more cost-effective in terms of costs per 3-, 6- and 12-month cessation rates and quit attempts. The investigators will use these results as inputs to the CISNET model to project the long-term impact of the interventions on costs per life year saved and quality-adjusted life years saved, lung cancer deaths averted, lung cancer mortality reduction, and overall population mortality.

This study's strengths include the assessment of effective cessation methods designed for widespread implementation, novel components based on unique features of screening, cost-effectiveness analyses, and leveraging the University of Michigan CISNET model to project the population impact of implementing an effective cessation intervention in lung screening programs. The overall goal is to have a substantial public health impact by providing critical data to address scalability efforts by screening centers, insurers, and policy-makers.

The Lung Screening, Tobacco and Health Project

Integrating Evidence-Based Smoking Cessation Interventions Into Lung Cancer Screening Programs: A Randomized Trial

Deidentified patient data will be shared with the National Cancer Institute as part of the SCALE collaboration.

Comparison between study arms of 7-day and 30-day point prevalence cessation with biochemical verification. The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).

Comparison between study arms of 7-day and 30-day point prevalence cessation. The investigators will also assess quit rates among subgroups (gender, age, nicotine dependence, site).

Measured using the 10-point contemplation ladder.

The investigators will assess the number and length of prior quit attempts at baseline. At all follow-up assessments, the investigators will assess the number and length of quit attempts that have occurred since the previous assessment.

Measurement of counselor adherence to the TC protocol, which will be assessed on 10% of randomly selected participants.

Reach: % of eligible smokers enrolled in trial; Engagement: % who receive the TC and the nicotine patch interventions), both overall and among subgroups (gender, age, nicotine dependence, site)

Patient time costs in the interventions; fixed costs (space, overhead) and variable costs (intervention delivery and patient participation) by arm

Hackensack Meridian Health

Baptist Health South Florida

Lahey Hospital & Medical Center

University of Michigan

National Cancer Institute (NCI)

Unity Point Health

MedStar Shah Medical Group

Anne Arundel Medical Center

Georgetown University

The ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening

The usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks and an educational brochure about lung cancer screening

The ESCAPE intervention consists of five components:1) behavioral counseling, 2) the use of NRT, 3) digital SNC 4) decision aid about LDCT screening, and 5) a letter and educational materials sent to the primary care provider.

Escape

Participants in the standard care arm (brief advice and referral to quit line), will be referred to the MA Quitline which provides free NRT by the study team and will receive an educational brochure related to lung cancer screening.

Standard Care

Mary E. Cooley, PhD

This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening.

In this research study involves Studying the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program compared to usual care.

The ESCAPE program was developed help women with HIV quit smoking. Women in the ESCAPE program quit smoking and stayed quit for longer (up to 3 months). For this study, investigators have added a lung screening to the ESCAPE program and want to test if this will improve lung health through increasing quit rates and lung screening.

.

* This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening. The research study procedures include: screening for eligibility and study interventions including participation in counseling and completion of questionnaires by e-mail, phone or in-person.
* This research study involves participating in either the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program or the usual care. Participants will be randomized into one of two groups:

  * ESCAPE: The ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening
  * Usual Care: The usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks
* Participants will be in this research study for up to 6-months.
* It is expected that about 250 people will take part in this research study.

Digitally Enhanced Smoking Cessation for High Risk Smokers

A Digitally-enhanced Smoking Cessation Intervention for High-risk Smokers: Phase II

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

biochemical verification of smoking status will be done and the %7-day point prevalence abstinence will be compared between two groups with exact binomial test,

self-report number of cigarettes will be compared with exact Poisson test.

(stage of low-dose computed tomography \[LDCT\] screening adoption) Lung Cancer Screening Behaviors\[20\] will be measured with a questionnaire based on the Precaution Adoption Process Model. This model has seven stages of adoption which includes; stage 1=no awareness of lung cancer screening, stage 2=not engaged with lung cancer screening, stage 3=deciding about action, stage 4= decide not to screen, stage 5=decided to act, stage 6-=acting, and stage 7=maintenance. stage of change will be compared between two groups with exact binomial test,

The evaluation of the storytelling narrative communication at 1 and 3 months will be defined as follows:1) \> 80% receipt and completion rate of watching the SNC digitalized videos.

Descriptive statistics (estimate and 95% CI) will be used to report completion rate.

defined as \> 80% of the group perceive the film as just right in length in addition to favorable comments, the Narrative Engagement Scale scores are ≥ to the established means ). Descriptive statistics (estimate and 95% CI) will be used to report percentage and one-sample t-test will be used to compare Narrative Engagement Scale scores to the established means.

\> 80% of the group comments indicate that the film would have value to others and the Narrative Engagement Scale scores are ≥ to the established means. Descriptive statistics (estimate and 95% CI) will be used to report percentage and one-sample t-test will be used to compare Narrative Engagement Scale scores to the established means.

The ratings of SNC videos will be evaluated using the Narrative Engagement Scale that will be administered at 1 and 3 months \[37\] The scale is a paper and pencil questionnaire developed to measure the extent to which the viewer of narratives in a variety of forms (film, TV etc.) becomes engaged, transported, or immersed in the narrative and the potential of the narrative to affect change in story-related attitudes and beliefs. The scale scores range from 1-7 with 7 indicating greater engagement.

The ratings of SNC videos will be evaluated using the Narrative Engagement Scale that will be administered at 1 and 3 months \[37\] The scale is a paper and pencil questionnaire developed to measure the extent to which the viewer of narratives in a variety of forms (film, TV etc.) becomes engaged, transported, or immersed in the narrative and the potential of the narrative to affect change in story-related attitudes and beliefs. The scale scores range from 1-7 with higher scores indicating greater engagement.

We will construct three PRS. The first will be based on the lead single nucleotide polymorphisms (SNPs) from 183 independent genetic loci associated at genome-wide significance (p\<5x10-8) with ever smoking status in adults from the UK Biobank and the Tobacco and Alcohol Genetic Consortium. The risk will be calculated as the weighted sum of each genetic variant, under an additive genetic model, counting the number of copies of the risk increasing allele. The weights will be proportional to the estimated effect size of each SNP. The second risk score will be constructed from a larger set of SNPs (\~1 million) from the same GWAS using LDPred that allows for the construction of more powerful PRSs for specific racial groups using linkage disequilibrium information from large genetic reference panels. Finally, we will also construct a PRS based on the GWAS results for the largest available study specifically for nicotine dependence using the LDPred approach.

A semi-structured interview will be conducted with participants. Topics for the interview guide include; 1) perceptions of genomic evaluation, 2) experiences for providing risk information, 3) preferences for receiving risk information, 4) experiences with the study interventions, 5) suggestions for program improvements.

American Association for Cancer Research

Dana-Farber Cancer Institute

Principal Investigator

Varenicline

50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration.

49 participants will be enrolled in this group.

varenicline comes in bottles of 56 - 0.5 mg pills

Varenicline 0.5 MG

The purpose of this study is to learn what happens when people are given a free, 4-week, sample of varenicline, a smoking cessation medication. Investigators will look at quit attempts, changes in smoking, and attitude towards varenicline, in both smokers who want to quit and those who do not.

Smoking use causes a number of deaths and diseases, including heart disease and cancer. All smokers are advised to quit. Varenicline (sometimes called Chantix), is a prescription medication approved by the US FDA. Many studies show that use of varenicline can help smokers quit smoking.

Varenicline is a prescription medication, which usually means that people have to see a doctor to get it. This study examines a different way to deliver varenicline, delivered directly to participants for a few weeks, and without need to see a doctor. This method is called "varenicline sampling."

The study is sponsored by the Hollings Cancer Center at the Medical University of South Carolina. The study is being done at the Medical University of South Carolina, but study recruitment is based state-wide, throughout South Carolina.

Participants will be randomized into one of the two study groups, like drawing numbers from a hat. One group will receive a mailed sample of varenicline, and the other will not. Participants have 50/50 chance of being in either group. Both groups will contain equal numbers of smokers motivated to quit and smokers not currently motivated to quit.

Hollings Cancer Center Varenicline Sampling Study

A Pilot Translational Study of Varenicline Sampling to Promote Treatment Engagement and Smoking Cessation

Percent of participants with any self-defined and any self-defined 24-hr quit attempt

Percent of participants in the sampling group using varenicline at 3-month follow up assessment.

Medical University of South Carolina

50 participants will be enrolled in this group. They will receive a sample of varenicline to use for up to 4-weeks. They are receiving 40 - 0.5mg pills of varenicline, with instructions for titration.

Varenicline 0.5 MG: varenicline comes in bottles of 56 - 0.5 mg pills

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
PRogetto Salute Parma	NCT04282694	Smoking Smoking Habit Smoking, Tobacc... Smoking, Cigare... Smoking Cessati... Lung Cancer	Low-dose comput...	50 Years - 74 Years	University of Parma
The Lung Screening, Tobacco and Health Project	NCT03200236	Smoking, Tobacc... Tobacco-Related... Tobacco Use Lung Cancer Scr...	Intensive Telep... Usual Care: Tel...	50 Years - 80 Years	Georgetown University
Digitally Enhanced Smoking Cessation for High Risk Smokers	NCT04691297	Smoking Smoking Cessati... Lung Cancer Scr... Smoking, Tobacc... Smoking Behavio...	Escape Standard Care	55 Years - 77 Years	Dana-Farber Cancer Institute
Hollings Cancer Center Varenicline Sampling Study	NCT03742154	Smoking Smoking Cessati... Smoking, Tobacc... Smoking, Cigare...	Varenicline 0.5...	18 Years -	Medical University of South Carolina
The Lung Screening, Tobacco and Health Project	NCT03200236	Smoking, Tobacc... Tobacco-Related... Tobacco Use Lung Cancer Scr...	Intensive Telep... Usual Care: Tel...	50 Years - 80 Years	Georgetown University

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