Tobacco Cessation Program for Tobacco Use

Overseen By Erika Barahona, M. Ed

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Disqualifiers: Incarceration, Detained, Language barriers, others

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

Compensation: Varies

Number of Visits: 4

204 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help cancer survivors and their caregivers quit tobacco. It offers a personalized nicotine cessation program to support quitting and provides healthcare providers with training to assist in this process. The trial seeks current tobacco users who have a history of cancer or are caregivers of cancer survivors and are receiving care from specific UF Health clinics. Given the challenges of quitting tobacco after a cancer diagnosis, this trial provides the necessary tools and support to make quitting more achievable.

As an unphased trial, participants benefit from tailored support and contribute to valuable research that aids others in similar situations.

Do I have to stop taking my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this nicotine cessation program is safe?

Research has shown that quitting smoking significantly reduces the risk of diseases related to tobacco use. Programs designed to help individuals stop smoking often incorporate tools like nicotine patches or e-cigarettes, which are generally easy to use. For instance, combining a quick-acting nicotine product with a patch can slightly increase the chances of quitting, and these methods are safe for most people.

Most side effects from nicotine replacement products are mild, such as skin irritation from patches or a sore throat from e-cigarettes. These issues are usually manageable and not serious.

The program in this trial aims to help cancer survivors and their families quit smoking. Although specific safety data for this program is not available, treatments to quit smoking are generally safe and effective in helping many people stop using tobacco. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Nicotine Cessation Program because it offers a fresh approach to quitting smoking. Unlike traditional methods like nicotine replacement therapy or medications such as bupropion and varenicline, this program might integrate behavioral support and personalized strategies. These elements can address the psychological and habitual aspects of smoking, which are often overlooked by current treatments. By potentially providing a more tailored experience, the program could enhance success rates for individuals looking to quit tobacco for good.

What evidence suggests that this nicotine cessation program is effective for tobacco use?

Research has shown that organized programs to help people quit smoking can greatly improve their chances of success. On their own, only about 3% to 5% of people manage to quit smoking. However, joining these programs can significantly increase the success rate. Some studies found that up to 83% of participants quit smoking within a year. This trial will evaluate the effectiveness of a Nicotine Cessation Program, which offers support and resources to ease the quitting process, especially for cancer survivors who may face additional challenges when trying to stop smoking. ^{2 6 7 8 9}

Who Is on the Research Team?

Jennifer LeLaurin, PhD

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

This trial is for cancer survivors, including those currently in treatment, and their caregivers who use tobacco. Participants must be capable of completing study tasks and receiving care from specific UF Health clinics. They need to have used tobacco recently and consent to the study's processes.

Inclusion Criteria

I have signed the consent form and agree to follow the study rules.

I am a caregiver or family member of someone who has survived cancer.

I am a caregiver or friend of a cancer survivor at UF Health.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Nicotine Cessation Program

Participants, including cancer survivors and caregivers, engage in a tailored nicotine cessation program

8 weeks

4 sessions

Healthcare Provider Training

Healthcare providers receive training on the AAC model and C-LEAR approach for tobacco cessation in cancer care

1-2 weeks

Follow-up

Participants are monitored for program effectiveness and satisfaction, including tobacco cessation success

3-5 months

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine cessation program

Trial Overview The trial tests a tailored nicotine cessation program for cancer survivors and their caregivers. It includes two strategies: a personalized quitting program and healthcare provider training using the AAC model (Ask, Advise, Connect) plus C-LEAR communication skills.

How Is the Trial Designed?

Group I: Nicotine Cessation Program Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10858725/

A Review of Smoking Cessation Interventions - PubMed Central Moreover, attempting to quit smoking without any structured approach yielded a mere 3%-5% success rate within the same timeframe [7]. This study ...

2. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7329a1.htm

Adult Smoking Cessation — United States, 2022 | MMWR Among adults who currently smoked or who quit in the last year, 77.6% (95% CI = 75.7%–79.4%) and 83.1% (95% CI = 78.6%–87.1%), respectively, saw ...

3. tobaccoinduceddiseases.org tobaccoinduceddiseases.org/The-effectiveness-of-tobacco-cessation-programs-for-university-students-A-systematic,162001,0,2.html

The effectiveness of tobacco cessation programs for ... Outcomes varied from cognitive changes, such as knowledge, to behavior changes, such as refraining from smoking initiation or quitting smoking.

4. mhealth.jmir.org mhealth.jmir.org/2022/11/e41658

Outcomes of a Comprehensive Mobile Smoking Cessation ... This study aimed to compare engagement, retention, attitudes toward quitting smoking, smoking behavior, and participant feedback between Pivot and QuitGuide.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10252602/

Effectiveness of a Smoking Cessation Program during the ... A systematic review of studies exploring different cessation methods revealed that abstinence rates decreased with time.

6. cdc.gov cdc.gov/tobacco/php/data-statistics/smoking-cessation/index.html

Smoking Cessation: Fast Facts | Smoking and Tobacco Use Quitting smoking greatly reduces the risk of developing smoking-related diseases. Tobacco dependence is a condition driven by nicotine addiction ...

7. truthinitiative.org truthinitiative.org/research-resources/quitting-smoking-vaping/quitting-tobacco-facts-and-stats

Quitting Tobacco: Facts and Stats In 2020, 8.5% of adult current smokers successfully quit smoking in the past year, up from 7.5% in 2018.

8. aafp.org aafp.org/pubs/afp/issues/2022/1100/smoking-cessation-interventions.html

Smoking Cessation Interventions Pooled data from multiple studies showed that the use of e-cigarettes containing nicotine increases smoking cessation at six months (NNT = 25) compared with ...

9. tobaccopreventioncessation.com tobaccopreventioncessation.com/

Tobacco Prevention & Cessation An open access, peer-reviewed online journal that encompasses all aspects of tobacco use, prevention and cessation.