Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Behaviors and Mental Disorders

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Quality of Life

smoking

1. Understanding the smoking change patterns among the newly diagnosis lung cancer patients after cancer diagnosis.
2. Explore the related factors of the smoking change patterns.
3. The type of smoking trajectory impact on survival and quality of life.

This was a prospective longitudinal design study. The investigators used the structure questionnaires to collect the data from a consecutive sample of newly diagnosed lung cancer patients.

Study of Smoking Trajectory in Newly Diagnosis Lung Cancer Patients

Smoking Trajectory in Newly Diagnosis Lung Cancer Patients

Self-reported smoking during the last 30 days was a dichotomous variable.

Functional Assessment of Cancer Therapy-Lung, Version 4 (FACT-L v. 4) was a 36-item ordinal scale, five-point scale from 0 (not at all) to 4 (very much). There were 5 domains: Physical, social/family, emotional, and functional well-being; lung cancer subscale (symptoms, cognitive function, regret of smoking). Subscale scores added to obtain total score, with higher scores indicating better quality of life.

National Defense Medical Center, Taiwan

Principal Investigator

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

Skin and Connective Tissue Diseases

Breast Neoplasms

Integrated intervention of smoking cessation and breastfeeding

Instructions on general pregnancy and infant care

The intervention group will receive an integrated intervention of smoking cessation and breastfeeding: education and counseling, monitoring and feedback, and contingent financial incentives.

Participants in the control group will receive usual prenatal care from physicians, nurses, or social workers. They will receive best standard care on smoking cessation and breastfeeding, including referral to the New York State Smokers' Quitline and the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC).

Attention placebo control

Xiaozhong Wen, MD, PhD

This pilot clinical trial aims to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their early pregnancy and randomize them into the integrated intervention or control group. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum.

The investigators are proposing the first randomized controlled trial to integrate maternal smoking cessation and breastfeeding interventions to enhance both cancer prevention behaviors. The investigators will recruit 40 daily smoking women in their 1st or 2nd trimester of pregnancy (≤28 weeks) from local obstetric clinics, communities, and social media. They will be randomized into either the intervention (N=20) or control group (N=20). The two groups will complete the same number of sessions (6 during pregnancy and 3 postpartum), but focus on different topics. Specifically, the control group will receive instructions on general pregnancy and infant care. The intervention group will receive instructions on general pregnancy and infant care, plus an integrated multicomponent intervention that promotes both smoking cessation and breastfeeding (i.e., education and counseling, monitoring and feedback, and contingent financial incentives). Two female Certified Lactation Counselors (interventionists) will be trained to run study sessions during home visits. Interventionists will provide additional support via phone and text messaging until 6 months postpartum. Main outcomes include smoking abstinence and breastfeeding rates at 6 months postpartum within the duration of this award.

The 40 eligible participants will be randomized into either the intervention (N=20) or control group (N=20). A sequence of random numbers in blocks of 2 will be used to ensure equal numbers of participants for each group over time.

Research staff who collect and analyze outcome data will be blinded to participants' group assignments.

Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding

Based on their recorded daily numbers of cigarettes and cigars smoked after enrollment, the investigators will classify smoking abstinence status in the past 7 days (7-day point-prevalence).60,61 The self-reported smoking abstinence will be biochemically confirmed by urine cotinine tests (\<50 ng/mL).

During pregnancy, participants will report breastfeeding intention using questionnaires modified from the Infant Feeding Practices Study II.

During postpartum, mothers will report breastfeeding status (exclusive, mixed with formula, non-breastfeeding) every month until 6 months postpartum.

During postpartum, mothers will report breastfeeding frequency (times per day) every month until 6 months postpartum.

During postpartum, mothers will update breastfeeding duration (weeks) every month until 6 months postpartum.

During postpartum, mothers will update formula duration (weeks) every month until 6 months postpartum.

National Center for Advancing Translational Sciences (NCATS)

Xiaozhong Wen

Associate Professor

The intervention entitled Motivating Pacifika Against Cigarettes and Tobacco (MPACT) was implemented for eight weeks starting on the quit date that the participant chose with their assigned coach during the baseline assessment. At the baseline assessment, each participant watched an introductory video that described the online smoking cessation program. The online program was accessed through the participant's Facebook account. The program included eight education modules and a forum. Participants also received automated daily text messages to provide support and encouragement during the quitting process.

Participants in the control group set a quit date within two weeks of their baseline assessment and watched an introductory video that described the smoking cessation program. They received one text message every other week over a period of eight weeks following the quit date. The messages were delivered by a web-based system not connected to the online intervention program. Participants were also given a handout listing local tobacco cessation and education resources, a link to a generic online smoking cessation program, a fact sheet on smoking and tobacco use among PI young adults, and a quit kit containing chewing gum and a stress ball.

Participants received one encouraging text message per day prior to their quit date. During the intervention, they received daily text messages with decreasing frequency per week. Participants were also able to craft personal text messages. On-demand text messages were optional and could be requested by texting key words to the program hotline.

The online MPACT program allowed participants to access eight educational modules and a forum where they could communicate with other participants. The modules focused on different aspects of quitting smoking, such as how to deal with withdrawal symptoms, triggers of tobacco use, and stress. Participants were limited to one module per day in order to increase the duration of exposure to the program. Upon completion, participants no longer received text messages but they were still able to access the educational modules, forum, and on-demand text messages.

Motivating Pacifika Against Cigarettes and Tobacco

The current study aimed to test a culturally tailored program designed to help Pacific Islanders (PIs) between the ages of 18 and 30 quit smoking cigarettes by using a randomized controlled trial design with one intervention group and one control group.

This randomized control trial (RCT) consisted of a baseline assessment (Wave 0) and three follow-up assessments (Waves 1-3). Follow-up assessments were conducted at 2 months, 5 months, and 8 months after the baseline assessment. The objective of the study was to test a culturally-tailored online program designed to help PI young adults quit smoking cigarettes. The online program contained (1) personalized, automated text messages, (2) interactive, online educational modules, and (3) an online forum.

Hypotheses for this study include:

1. Participants in the intervention program tailored to PIs would have significantly higher rates of abstinence, lower rates of relapse, and lower smoking frequency and intensity at each follow-up time point than those in the standard intervention program.
2. Participants with impaired affective decision capacity (low scores on Iowa Gambling Task (IGT)) would benefit more from the tailored intervention program than participants with normal affective decision capacity (high IGT scores).
3. Effects from the tailored intervention program would be more pronounced among participants with particular dispositional phenotypes (depression, hostility, impulsivity) and baseline severity of tobacco addiction (nicotine dependence).
4. High-intensity users of the tailored intervention program would be more successful than low intensity users in reducing the frequency and intensity of cigarettes smoked.
5. The tailored intervention program would have greater success at engaging and retaining participants than the standard intervention program.

Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco

Weaving an Islander Network for Cancer Awareness, Research and Training (WINCART): Technology & Smoking Cessation for Late Adolescent/Young Adult Pacific Islanders

De-identified datasets with individual participant data will be provided by the Principal Investigator upon request. All data sharing requests will be reviewed and approved by the Office of Research and Sponsored Programs at Claremont Graduate University and the WINCART2 Center Steering Committee.

How many cigarettes has the participant smoked in the last 30 days?

Has the participant smoked a cigarette in the past 7 days?

Has the participant smoked a cigarette in the past 24 hours?

Biomarker validation (expired CO) of self-reported tobacco use

National Cancer Institute (NCI)

Claremont Graduate University

All Drugs and Chemicals

Varenicline

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

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
Study of Smoking Trajectory in Newly Diagnosis Lung Cancer Patients	NCT03642041	Newly Diagnosed... Smoking, Cigare... Survival Quality of Life	smoking	20 Years -	National Defense Medical Center, Taiwan
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
Lung and Breast Cancer Prevention by an Integrated Intervention of Maternal Smoking Cessation and Breastfeeding	NCT05123118	Smoking, Cigare... Breastfeeding	Integrated inte... Attention place...	18 Years -	State University of New York at Buffalo
Smoking Cessation for Young Adult Pacific Islanders: Motivating Pacifika Against Cigarettes and Tobacco	NCT03238456	Tobacco Use Tobacco Smoking Tobacco Use Ces... Smoking Smoking Cessati... Smoking, Cigare...	Motivating Paci...	18 Years - 30 Years	Claremont Graduate University
Hollings Cancer Center Varenicline Sampling Study	NCT03742154	Smoking Smoking Cessati... Smoking, Tobacc... Smoking, Cigare...	Varenicline 0.5...	18 Years -	Medical University of South Carolina

Spots Global Cancer Trial Database for smoking, cigarette