Precision Treatment for Quitting Smoking in Cancer Patients

(PROMISE Trial)

Overseen By Theodore Thomas, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Must not be taking: Smoking cessation medications

Disqualifiers: Cardiac problems, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a personalized approach to help cancer patients quit smoking by using their unique clinical and genetic information. The aim is to determine if this precision treatment, a tailored therapy, is more effective than usual care in helping patients stop smoking for at least six months. Participants who smoke at least five cigarettes a day and are open to using medications like nicotine patches or lozenges may be a good fit for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could lead to more effective smoking cessation strategies.

Will I have to stop taking my current medications?

The trial requires that you have not used smoking cessation medication in the past 30 days. If you are currently using such medications, you would need to stop before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that precision treatments are usually easy for patients to handle. This method uses personal health details, such as medical history, genetic information, and specific health markers, to customize care. Although specific safety data for this precision treatment in cancer patients is not available, this approach generally focuses on personalized care, often resulting in fewer side effects because it is tailored to each person.

The precision treatment being tested is based on existing knowledge about how personalized care can help people quit smoking, especially those with cancer. Personalized treatments aim to reduce side effects by considering each patient's unique health profile. While specific safety data isn't available from the sources provided, personalized approaches are generally considered a careful way to meet individual needs. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Precision Treatment for quitting smoking in cancer patients because it tailors tobacco cessation strategies specifically for individuals undergoing oncology care. Unlike the usual guideline-based care that provides a one-size-fits-all approach, Precision Treatment adapts recommendations based on each patient's unique needs and circumstances, potentially improving effectiveness. This personalized approach could better support cancer patients in overcoming tobacco addiction by considering their specific health conditions and treatment plans.

What evidence suggests that this trial's treatments could be effective for quitting smoking in cancer patients?

Research shows that precision tobacco treatment, which participants in this trial may receive, can help cancer patients quit smoking by customizing the approach for each individual. This method uses information such as a patient’s medical history, genetic details, and specific body markers to select the best treatment plan. Previous studies suggest that these personalized strategies might increase the chances of quitting smoking and improve health outcomes. Early research indicates that people with tailored treatment plans often use medication more regularly and are more likely to remain smoke-free. This approach aims to give each patient the best chance of success by making the treatment as relevant as possible to their unique situation. ^{1 2 3 6 7}

Who Is on the Research Team?

Li-Shiun Chen, ScD, M.D., MPH

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for oncology patients who are current smokers. It aims to help them quit smoking by using a personalized approach that considers their clinical, genetic, and biomarker information. The goal is to see if this precision treatment improves the rate of quitting compared to usual care.

Inclusion Criteria

Clinician from participating oncology/hematology clinic

Can speak and understand English

Patient at participating clinic

Exclusion Criteria

Patients who were deemed by the investigator to be ineligible for participation in the trial

I have used smoking cessation medication in the last 30 days.

I have recently started or been prescribed medication to quit smoking.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive precision tobacco treatment or usual care, including personalized recommendations and discussions with a behavior interventionist

6 months

Follow-up

Participants are monitored for smoking abstinence, quality of life, and survival

6 months

Extended Follow-up

Participants continue to be monitored for long-term outcomes such as quality of life and survival

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Precision Treatment

Trial Overview The study compares two methods: 'usual care' which might include standard advice and treatments for quitting smoking, versus 'precision treatment', which tailors the cessation strategy based on individual patient data. The impact on tobacco use and abstinence at 6 months will be measured.

How Is the Trial Designed?

Group I: PrecisionTx-Onc (oncology) Experimental Treatment 1 Intervention

Clinicians will receive PrecisionTx-Onc, an intervention designed to recommend precision tobacco treatment, adapted for oncology. Patients will receive PrecisionTx-Onc, an intervention designed to recommend precision tobacco treatment, and a brief discussion with a behavior interventionist, adapted for oncology.

Group II: Usual Care Active Control 1 Intervention

The arm will represent usual care in the oncology care clinics. Clinicians will receive a report designed to recommend guideline-based tobacco treatment. Patients will receive a report on guideline-based advice about smoking cessation and a brief discussion with a behavior interventionist.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07166120

Precision Treatment to Promote Smoking Cessation and ... This study will test the impact of a multilevel precision treatment intervention on improving tobacco treatment and health outcomes in oncology ...

2. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2025-07102

Personalized Precision Treatment Recommendations for ... PrecisionTx offers personalized precision treatment recommendations based on the patient's clinical factors, biomarkers, and genetic factors. Precision ...

3. patlynk.com patlynk.com/trial/NCT07166120

Precision Tobacco Treatment for Smoking Cessation in ... This study focuses on helping cancer patients quit smoking by using a personalized approach to tobacco treatment. The goal is to provide each patient with ...

4. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2825372

Survival Outcomes of an Early Intervention Smoking ... This cohort study evaluates the survival outcomes of currently smoking patients with cancer who entered into a smoking cessation treatment program based.

5. reporter.nih.gov reporter.nih.gov/project-details/11109450

RePORT RePORTER - National Institutes of Health (NIH) | This study will test the impact of a multilevel precision treatment intervention on improving tobacco treatment and health outcomes in primary care. NIH ...

6. mdanderson.org mdanderson.org/newsroom/chances-of-quitting-smoking-improve-with-integrated-care-including-medication-and-counseling.h00-159773289.html

Chances of quitting smoking improve with integrated care ... Smokers undergoing lung cancer screening may have the best chance of quitting if they receive integrated care, which includes medication and comprehensive ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e14658

Impact of smoking on immunotherapy outcomes in cancer Conclusions: Our findings demonstrate a significant negative impact of smoking on immunotherapy outcomes, including PFS and adverse event ...