Neoplasms

Mouth and Tooth Diseases

All Conditions

Rare Diseases

Mouth Neoplasms

Lip Neoplasms

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

Professional help in the form of health awareness sessions, focus group discussion, one to one counseling and pharmacotherapy was provided to the employees by a team of doctors and counselors from Tata Memorial Hospital. Self reporting of tobacco history was validated with Rapid Urine cotinine test. Naked eye examination of oral cavity of all employees for detection of oral pre-cancers and cancers was conducted. Nursing staff and Doctors attached to the industry and from the local referral hospital were invited to participate as trainees during the active intervention sessions for local manpower development.

Behavioural and Pharmacotherapy for tobacco cessation

Tata Memorial Hospital has initiated Workplace Tobacco Cessation and Oral Cancer Screening Programme in Chemical Industry at Khed, Ratnagiri. Appropriate interventions for tobacco cessation will be carried at monthly intervals for twelve months duration. The tobacco cessation rates based on history will be validated with the urinary cotinine levels.

The prevalence of tobacco use in India among men has been reported to be high in most parts (generally exceeding 50%). It's use is more common in rural areas as compared to urban areas. Oral cancer, the main cause of which is tobacco, is common in men in developing countries and the most common cancer among men in India. The five year survival rate for oral and pharyngeal cancers even in premier institute like the Tata Memorial Hospital ranges from a poor 8% (hypo pharynx) to 43% (lower lip). Evidence has shown that cessation is the only intervention with the potential to reduce tobacco related mortality in the short- term and medium- term. An emphasis on prevention of tobacco consumption will, in the short run, only have a limited positive effect on tobacco related morbidity and mortality, as prevention strategies do not affect existing consumers. Workplace tobacco cessation activities in India are still in rudimentary stage.

In the proposed study of one year duration, professional help in the form focus group discussion, one to one counseling and pharmacotherapy will be provided to the employees by a team of doctors and counsellors from Tata Memorial Hospital. Self reporting of tobacco history will be validated with Biochemical test. This will add objectivity to the programme, so that, if successful, it can be replicated as a model to promote tobacco control activities at other workplaces. Naked eye examination of oral cavity of all employees for detection of oral pre-cancers and cancers will be done by doctors from the Tata Memorial Hospital. The employees with lesions may be referred for further management, if required. Nursing staff and Doctors attached to the industry and from the local referral hospital will be invited to participate as trainees during the active intervention sessions.

The long term objective of this initiative is to establish a model workplace tobacco cessation and oral cancer screening programme. It will contribute to the human resource and infrastructure development for tobacco cessation services at the industrial unit and at the local referral hospital. Proposed tobacco cessation services in the chemical industry would be of great help for boosting Anti - Tobacco Activities not only in the particular factory unit but also in the nearby industrial and residential zone.

Workplace Tobacco Cessation And Oral Cancer Screening Study

Department of Atomic Energy

Tata Memorial Hospital

Dr. Gauravi Ashish Mishra, Assistant Professor and Assistant Physician

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Lyon Hospital employees meeting criteria for high risk of lung cancer according French recommendation criteria.

3 levels of solicitation will be cumulated. First : a Simple collective solicitation of all staff via internal media 4 months later : Personalized indirect solicitation of at-risk groups with information posted in identified areas 4 months later : Personalized direct solicitation of at-risk groups

Solicitation for lung cancer screening

* spirometry examination
* Questionnaires
* Blood samples and breath samples to find biomarkers

added exams to the usual lung cancer screening

Sébastien COURAUD, Pr

Julie DE BERMONT

Michael DURUISSEAUX, MD

Lize KIAKOUAMA-MALEKA, MD

Sébastien COURAUD, PhD

Several randomized studies have demonstrated the efficiency of lung cancer screening (LCS) on mortality rates. However, screening efficiency is related to the targeted population and the participation rate.

In France, the participation rate for breast and colon cancer screening programs is respectively 50% and 32%, which is low. Then, it appears very important to determine which factors are influencing the willingness to participate to these programs. Indeed, it will allow a better communication and we will be able to perform screening campaigns adapted to the eligible population.

The Lyon Hospital is the second university hospital in France. It is composed of 14 buildings and employed 23 000 persons. More than 160 occupations are represented. So, hospital employees look relevant to be studied for LCS program.

ILYAD was divided in 2 parts. The first one was completed in 2020 and goal to evaluate the number of eligible individuals among the hospital employees. About 800 persons would be eligible for LCS.

This second part of the study will evaluate the participation rate and the feasibility of the LCS program. The study will target the 800 individuals that were identified previously.

Lung Cancer Screening Implementation Among Employees at Lyon Hospital

Pilot Study on Lung Cancer Screening Implementation Among Employees at Lyon Hospital

Ratio between the number of participants who underwent a CT scan at baseline and the estimated number of eligible employees

Ratio between the number of participants who underwent the baseline CT scan at level 1, 2 and 3 and the estimated number of eligible employees

Using the cox model to identify sociodemographic factors that could be associated with the participation rates for both round of CT scan.

Ratio between individuals who completed baseline and year 1 CT scan and the number of participants. And, the ratio of individuals who beneficiated conform care according to French recommendations.

Ratio of lung cancer diagnosed Ration of ILD diagnosed Ratio of COPD diagnosed Ratio of smoking cessation

Ratio between the number of participants who underwent the Year 1 CT scan and the number of participants.

Perform blood analysis to identify specific biomarkers and compare their sensibility, and predictive value with or without association with the CT scan.

Perform air breath analysis to identify specific chemical species, compare their sensibility, and predictive value associated, and not with the CT scan.

Ratio between the participant at the cohort and who have done the scanner 2 years post Year1 one, and the participant at the cohort.

Hospices Civils de Lyon

All Drugs and Chemicals

Varenicline

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Opt-out counseling enrollment. individually-tailored biofeedback linked to Chest CT and spirometry results.

Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28.

1 mg twice day for 12 weeks after target quit date.

Opt-in counseling enrollment. Standard tobacco cessation counseling.

Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28.

1 mg twice day for 12 weeks after target quit date.

Participants automatically enrolled in motivational counseling. Tailored counseling includes sharing results of Chest CT results and lung function spirometry tests with participants.

opt out enrollment, tailored counseling, varenicline started prior to target quit date

Participants must opt-in to receive counseling. Counseling does not include discussion of Chest CT or spirometry results.

opt in enrollment, non-tailored counseling, varenicline started prior to target quit date

Shadi Nahvi, MD, MS

David Goldfarb, PhD

At the Fire Department of the City of New York (FDNY) World Trade Center Health Program, 36% of participants in the low dose computed tomography (LDCT) lung cancer screening program are current smokers, despite referral to the free FDNY Tobacco Cessation Program (Standard Care). Investigators propose testing an Enhanced Care program which includes opt-out enrollment; tobacco cessation counseling will be individually tailored to spirometry/LDCT results and treatment with varenicline starting 4 weeks prior to their target quit date. This randomized trial will compare enrollment and cessation outcomes in Standard Care vs. Enhanced Care groups of challenging-to-treat, high-risk smokers.

The overarching goal of this Randomized Controlled trial is to develop and test an effective, scalable intervention with potential to reach high-risk smokers undergoing CT lung cancer screening who have not engaged in or succeeded with traditional tobacco treatment approaches. The investigators will test an Enhanced Care intervention specifically designed to address multiple challenges to tobacco treatment engagement and success. First, the researchers will test opt-out enrollment in cessation treatment. The current tobacco treatment default, in which patients must opt-in to cessation treatment and are only offered counseling and pharmacotherapy when deemed ready to quit, results in missed opportunities to engage smokers into treatment. Previous studies of opt-out enrollment in cessation treatment suggest that an opt-out tobacco treatment strategy substantially increases engagement and cessation rates compared with traditional opt-in approaches. Second, proactive counseling will leverage the "reachable, teachable moment" of CT screening to motivate cessation through individually tailored messaging tied to CT results and lung function spirometry. Using CT results as a motivational tool has shown promise in pilot studies. The optimal approach and success of using CT coupled with spirometry results to motivate tobacco cessation remains unknown. Third, investigators will offer varenicline pre-loading to all enrollees, regardless of study arm, in which varenicline is initiated 4 weeks prior to target quit date. This approach is associated with decreased pre-quit tobacco-associated reward and double the rate of abstinence compared with standard varenicline treatment.

The investigators thus propose a randomized trial among retired FDNY World Trade Center Health Program responders eligible for the FDNY World Trade Center Health Program CT screening program to test the effects of Enhanced Care (opt-out enrollment, tailored counseling based on CT and spirometry results, and varenicline with preloading) against Standard Care (opt-in enrollment, standard cessation counseling without spirometry/CT tailoring, and varenicline with preloading) in the engagement of high-risk smokers in cessation treatment and the achievement of tobacco abstinence.

Tobacco Cessation at FDNY

Preventing Lung Cancer Through Tobacco Cessation at FDNY

Enrollment is defined as first visit attendance with our tobacco treatment specialist in FDNY's Tobacco Cessation Program: Standard vs. Enhanced Care arms.

Number of participants retained to study end-date

Assessed via electronic medication monitoring: pills taken / pills prescribed

Adherence with number of counseling visits attended as a continuous variable

7-day point prevalence abstinence biochemically verified by urine cotinine \< 30 ng/mL

FDNY World Trade Center Health Program

Albert Einstein College of Medicine

Minimal interaction between participant and facilitator regarding cessation strategies. Participants will only be given a betel nut cessation booklet.

Intensive 5-session intervention program over the span of 22 days, with an additional follow up session after 6 months. The sessions will utilize betel nut cessation social support groups, as well as interactive discussion on how to quit chewing.

The cessation sessions will be led by trained facilitators over 22-day period. Session 1 (Day 1) includes a discussion of health risks associated with betel nut chewing, and introduction to self-monitoring and triggers logs. Session 2 (Day 8) includes a review of their logs, and discussions of lifestyle changes to assist cessation of betel nut chewing. Session 3 (Day 15) will be the quit day for chewers. Coping mechanisms and plans to maximize social support will be discussed. Session 4 (Day 18) will focus on quitting experiences. Facilitators will also review the negative health effects when wanting to chew again. Discussion on quitting experiences will continue in Session 5 (Day 22). Facilitators will also address those who have experienced relapse, and how to manage relapse.

Betel Nut Cessation Social Support

Participants will receive minimal intervention via a single booklet that contains all the information offered in the experimental group, minus the social support sessions. The participants will meet with study staff individually at a designated office in Guam or Saipan to receive the betel nut cessation booklet, complete three assessments (baseline, 22 days, 6 months), and provide saliva samples.

Betel Nut Cessation Booklet

Yvette C Paulino, PhD, CPH

Thaddeus A Herzog, PhD

Areca nut, also known as betel nut, is the fourth most commonly consumed psychoactive substance in the world, following only alcohol, nicotine, and caffeine in prevalence of consumption. Although betel nut is chewed by approximately 600 million people globally, its use is concentrated in South Asia, Southeast Asia, and some Pacific Islands. Betel nut has been classified as a Group 1 carcinogen by the International Agency for Research on Cancer. Despite the global significance and carcinogenicity of betel nut, there has been very little behavioral or psychological research about betel nut chewing, and there has been no systematic research on the topic of betel nut cessation interventions. The current intervention builds directly upon the National Institutes of Health - National Cancer Institute's U54 University of Guam/University of Hawaii Cancer Center Comprehensive Partnership to Advance Health Equity. Previous data collected through the partnership suggest that betel nut chewers, like smokers, generally want and intend to quit, but do not have specific plans of how or when they will quit. In addition, most betel nut chewers in the partnership's previous study already have tried to quit on one or more occasions. The findings suggest that betel nut chewers could benefit from cessation programs modeled after smoking cessation programs. During 2014, partnership investigators conducted a feasibility study of the betel nut cessation program. The program was well received and yielded surprisingly high rates of self-reported betel nut cessation.

Specific Aim 1. To test the efficacy of an intensive group-based betel nut cessation program.

Specific Aim 2. To quantitatively determine the efficacy of the group-based betel nut cessation intervention trial using bio-verification.

The general framework employed to guide the intervention is cognitive-behavioral therapy. The cognitive-behavioral therapy is goal-oriented and problem-focused. The goal of the intervention is to help betel nut chewers to quit chewing betel nut using structured sessions. The cognitive component addresses chewers' attitudes and beliefs about betel nut chewing. Preliminary data from a feasibility study revealed that most participants initially underestimated such negative health effects of betel nut. The behavioral component of the intervention aims to replace chewing-promoting behaviors with behaviors that are more conducive to quitting betel nut and staying quit, and preparing responses for social situations where pressure to chew is likely to occur.

The structure of the proposed betel nut cessation program is modeled after a specific group-based cognitive-behavioral smoking cessation program. The program was selected because it is a well-established and evidence-based group cessation program. The intervention will consist of a 22-day, five-session support and informational group program. Betel nut use will be evaluated via surveys and bio-verification at three points: at the initial group meeting, at the final group meeting, and six months following the final group meeting.

Group Intervention Format and Procedures

Five group sessions will be conducted over a period of 22 days per cohort. Group meetings will be approximately one hour in length and will be conducted by study investigators and staff. Surveys will be administered at the first and last group meetings, as well as six months after the last meeting. Surveys will be self-administered at the beginning of the intervention sessions. Confidentiality will be emphasized at all meetings, but especially so in the first session, and will be addressed specifically in the informed consent document. Participants will be reminded that participation is completely voluntary and that withdrawal without penalty is always an option. At most sessions, handouts will be provided and topical "homework" will be distributed.

Saliva Samples

Saliva samples (ca. 1-2 mL) for intervention condition participants will be collected at the same times as the three survey assessments (baseline, the final group intervention session, and the six-month follow-up). Saliva samples for control condition participants (also ca. 1-2 mL) will be collected on the same schedule as the intervention condition participants. From the saliva samples, Dr. Adrian Franke's laboratory will measure by liquid chromatography mass spectrometry levels of salivary biomarkers previously identified in the pilot study, which identified compounds specific for areca nuts and betel leaves that were extracted while chewing three different betel preparations. The studies also revealed that the compounds are secreted into saliva and appear in chewers' saliva up to eight hours after the chewing event. To verify self-reports of betel nut abstinence, the investigators will set cut-offs for levels of alkaloids specific for areca nuts as follows: arecoline 60 ng/mL, arecaidine 10 ng/mL, guvacoline 20 ng/mL, and guvacine 6 ng/mL). Levels above the values will indicate evidence of recent betel nut consumption. Participants whose saliva tests reveal values above the specified cut-offs will be considered current chewers for the purposes of bio-verified outcomes (i.e., chewer or non-chewer status). The biomarker results will be used to compare self-reports of recent chewing behavior (amount and recency) with biomarker data to assess dose-response effects.

Saliva samples will be collected in Guam and Saipan in 20 mL conical polypropylene tubes which will be initially stored at -20°C. Aggregated samples will be shipped to Hawaii via FedEx. Shipments will be performed whenever 50-60 samples are successfully collected. After arriving in Hawaii, samples will be stored in Dr. Adrian Franke's lab at -80°C until analysis. All samples available at Dr. Adrian Franke's lab will be analyzed in one batch at the end of each annual cycle of the study.

Survey Assessments

Baseline Survey

The baseline survey will be administered during the first group session. Saliva samples will be collected.

First Follow-Up Survey

The first follow-up survey will be administered during the final group session. Participants will indicate any attempt to quit chewing betel nut since starting the intervention program, current chewing status (chewer or ex-chewer), number of group sessions attended (and reasons for absence, if applicable), and quid composition (if still chewing). The participants will also be asked several questions to measure satisfaction with the cessation program. Saliva samples will be collected for a second time.

Second Follow-Up Survey

Six months post-cessation, participants will arrange to meet with study staff to complete a final survey assessment. Participants will be asked again to evaluate the program, as well as follow-up questions regarding current chewing status and betel quid composition. Saliva samples will be collected for a final time.

Measurement of Cessation Outcomes

Primary cessation outcomes will be assessed by self-reported 7-day point prevalence abstinence bio-verified by the saliva tests. Participants who self-report chewing cessation but who test positive for the betel nut biomarker will be classified as chewers.

Data Analysis

The data analysis plan was designed under the direct guidance of the U54 Biostatistics Core. The goal of the analysis is to determine if the proposed intervention strategy affects cessation of betel nut chewing. Information on chewing behavior will be collected at baseline, month 1, and month 6 for the intervention (IN0, IN1, IN6) and control conditions (C0, C1, C6). The efficacy of the cessation program will be assessed by estimation and comparison of cessation prevalence over time, defined as the proportion who are not chewing betel nut. The first test of efficacy will compare the cessation status between randomization groups at month 1 and month 6, using a logistic mixed model, which will account for the repeated (correlated) measures within each individual. The independent variables will include randomization group (defined as intent-to- treat), time (parameterized as two indicator variables), location (Guam/Saipan), and interaction terms between group and time. Potential confounders, such as gender, ethnicity and age, will be added to the models. The F-test for the interaction term for 6 months will be the test of efficacy. Statistics of interest from the model include the odds ratio and 95% confidence interval (CI) comparing randomization groups, and the covariate-adjusted probabilities of cessation and their 95% CIs, predicted by group from the model. The data will be analyzed within subgroups, such as location (Guam or Saipan) to provide information on whether the intervention was more effective in select groups. The investigators will model treatment as the number of sessions attended to determine if the program was more effective in more compliant participants. The mixed model uses all available data points at each time point. If there is evidence of non-random missingness, such as by differential drop-out between groups, multiple imputation will be used to determine if missing data led to biased results.

Testing the Effectiveness of a Betel Nut Cessation Program

NIH-NCI U54 University of Guam/Cancer Center of Hawaii Partnership Full Project II: The Betel Nut Intervention Trial

This will measure cessation prevalence immediately after the program

This will measure cessation prevalence (stay-quit) long-term

Cut-off levels for betel nut biomarkers include arecoline (60 ng/mL), arecaidine (10 ng/mL), guvacoline (20 ng/mL), and guvacine (6 ng/mL).

National Cancer Institute (NCI)

University of Hawaii Cancer Research Center

University of Guam

We do a CT scan in active smokers and ex-smokers plus an spirometry combined to a tobacco cessation programme in active smokers

Low dose CT scan in active smokers or ex-smokers with an age between 50 and 75 years old

Lung cancer screening with low dose CT scan

Juan Carlos Trujillo Reyes, MD/PHD

Luis Seijo Maceiras, MD/PHD

The CASSANDRA project (Cancer Screening, Smoking Cessation, AND Respiratory Assessment) is a project led by SEPAR whose main coordinators are Dr. Luis Seijo, a pulmonologist at the Clínica Universitaria de Navarra, and Dr. Juan Carlos Trujillo-Reyes, a thoracic surgeon at the Hospital de la Santa Creu I Sant Pau and Coordinator of the Thoracic Oncology Area, in addition to the collaboration of a large number of professionals with expertise in lung cancer screening.

Despite its proven efficacy, Spain does not yet have a unified lung cancer screening protocol. The aim of the CASSANDRA project is to initiate a national screening program that can join forces with existing smoking cessation programs in Spain, which have proven to be insufficient in reducing the number of people affected by lung cancer.

CASSANDRA aims to analyze the feasibility of implementing a lung cancer screening program in Spain implemented in the public health system and carry out a cost-effectiveness analysis

CASSANDRA aims to be the first lung cancer screening pilot project in Spain. A project to assess the feasibility of implementation as well as to look for models that allow a better selection of the cases to be screened.

Cancer Screening Smoking Cessation AND Respiratory Assessment

Lung Cancer Screening Pilot Programme: Cancer Screening Smoking Cessation AND Respiratory Assessment

We have a PI in each center enrolled to the project. More than 40 hospitals are enrolled to the CASSANDRA project

Sociedad Española de Neumología y Cirugía Torácica

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Nicotine

Patients diagnosed with cancer (with at least one of the following ICD-10 diagnoses: C00-43; C46.1-99; D09)

Patients without cancer (without any of the following ICD-10 diagnoses: C00-99; D09; D30.1-9; D32-33; D35.2-4; D41.1-9; D44.3-5)

The intervention comprises 5-6 meetings during six weeks, and can be held in group or as an individual intervention. It is based on counselling and a clearly structured manual-based patient education programme taught by specially trained staff, and contains individual counselling on nicotine replacement therapy or other medical support, according to the level of dependence measured by the Fagerström test score. The first two weeks cover teaching sessions on: ambivalence and motivation, pros and cons of continuous smoking versus cessation, and a quit date is set between the 2. and 3. week. The last 3 sessions cover: risk situations, withdrawal symptoms and medical support for withdrawal symptoms, relapse prevention and how to handle a completely smoke-free life.

Intensive Smoking Cessation Intervention

Mette Rasmussen, PhD

Smoking accounts for approximately 30% of total cancer deaths each year. Even though former studies show that persons with a cancer diagnosis are less likely to smoke than the general population up to 50% of people who smoke and have lung cancer do not stop smoking after their diagnosis or frequently relapse after smoking cessation. Continued smoking leads to increased all-cause mortality, increased cancer-specific mortality, and decreased quality of life. It is well-known that cancer patients are interested in smoking cessation therefore smoking cessation interventions play an important role in the management of people with cancer.

This study will evaluate the effectiveness of an intensive smoking cessation interventions on cancer patients in real life. The project provides new knowledge about smokers diagnosed with cancer.

This prospective register-based cohort study including smokers attending an intensive smoking cessation intervention (the Gold Standard Programme (GSP)) from 2006-2017 in Denmark. The GSP is a manualised, patient education programme taught by specially trained staff, including pharmacologic strategies.

Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer

The Gold Standard Programme (GSP) for Smoking Cessation: Effectiveness in Smokers With and Without Cancer - a Prospective Cohort Study

Counsellor observed smoking status, questionnaire completed by counsellor

Self-reported smoking status, questionnaire completed by telephone interview

Self-reported patient-satisfaction, questionnaire completed by telephone interview

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Workplace Tobacco Cessation And Oral Cancer Screening Study	NCT00750503	Tobacco Cessati... Oral Cancer	Behavioural and...	18 Years - 60 Years	Tata Memorial Hospital
Lung Cancer Screening Implementation Among Employees at Lyon Hospital	NCT05452200	Lung Cancer	Solicitation fo... added exams to ...	50 Years - 75 Years	Hospices Civils de Lyon
Tobacco Cessation at FDNY	NCT05997225	Tobacco Use Tobacco Smoking Tobacco Use Ces...	opt out enrollm... opt in enrollme...	40 Years -	Albert Einstein College of Medicine
Testing the Effectiveness of a Betel Nut Cessation Program	NCT02942745	Betel Nut Chewe... Tobacco Cessati...	Betel Nut Cessa... Betel Nut Cessa...	18 Years -	University of Guam
Cancer Screening Smoking Cessation AND Respiratory Assessment	NCT06157957	Lung Cancer Protection Agai...	Lung cancer scr...	50 Years - 75 Years	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Tobacco Cessation at FDNY	NCT05997225	Tobacco Use Tobacco Smoking Tobacco Use Ces...	opt out enrollm... opt in enrollme...	40 Years -	Albert Einstein College of Medicine
Effectiveness of Intensive Smoking Cessation Interventions in Patients With Cancer	NCT04198688	Tobacco Smoking Cancer Tobacco Cessati...	Intensive Smoki...	18 Years -	Bispebjerg Hospital
Workplace Tobacco Cessation And Oral Cancer Screening Study	NCT00750503	Tobacco Cessati... Oral Cancer	Behavioural and...	18 Years - 60 Years	Tata Memorial Hospital

Spots Global Cancer Trial Database for tobacco cessation