Smoking CessationPROMISENCT07166120
Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients
A study testing Precision treatment in people with Smoking Cessation and Smoking, run by Washington University School of Medicine at 2 sites in United States.
Trial summary
This study evaluates the feasibility and preliminary effects of precision tobacco treatment, compared to usual care, on promoting tobacco treatment in oncology patients and providers in the oncology care setting. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Smoking Cessation, Smoking, Physician's Role
- What is being tested?
- Precision treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 2 sitesUnited States
- Study dates
- 11 Sep 2025to 30 Sep 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at participating clinic
- Age 18-89 years
- Current smoking (average cigarettes per day ≥5)
- Can speak and understand English
- Willing to consider medication to help reduce craving or smoking such as nicotine patch, lozenge, or varenicline
Who cannot join
- Active use of smoking cessation medication (within the past 30 days)
- Receipt of smoking cessation medication or prescription for smoking cessation medication (within the past 30 days)
- Having a contradiction for cNRT or varenicline (allergic reactions, current cardiac problems, pregnancy)
- Patients who were deemed by the investigator to be ineligible for participation in the trial
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Theodore Thomas, M.D. contact
United States2 sites, 2 recruiting
- Recruiting
John Cochran Veteran's Affairs Medical Center
St Louis, Missouri, 63106
Li-Shiun Chen, ScD, M.D.,MPH, 314-362-3932, li-shiun@wustl.edu
Li-Shiun Chen, ScD, M.D.,MPH
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Li-Shiun Chen, ScD, M.D., MPH, 314-362-3932, li-shiun@wustl.edu
Theodore Thomas, M.D., thomast@wustl.edu
About this study
This study evaluates the feasibility and preliminary effects of precision tobacco treatment, compared to usual care, on promoting tobacco treatment in oncology patients and providers in the oncology care setting. The precision treatment intervention includes personalized tobacco treatment recommendations using the patient's clinical, genetic, and biomarker information. This intervention may increase patient receipt of tobacco treatment, patient medication use, and patient smoking abstinence at 6 months.
Read the detailed description
This study aims to promote the provision and use of evidence-based tobacco treatment and patient survival by integrating precision tobacco treatment into oncology care as a novel multilevel intervention. This study builds on growing evidence that 1) precision treatment may optimize treatment effectiveness by precisely matching patients with the safest, most effective medications available and 2) precision intervention may boost the implementation and effectiveness of tobacco treatment. The multilevel precision treatment intervention to be tested-PrecisionTx-- provides the opportunity to present personalized risk, benefit, and treatment recommendation to increase clinician ordering, patient uptake, and overall effectiveness of tobacco treatment.
This study aims to understand the feasibility and preliminary effects of precision treatment over usual care and associated mechanistic and implementation outcomes. Therefore, the investigators propose a 2-arm cluster randomized controlled trial of 16 clinicians and 96 patients (~6 per clinician) from oncology care settings. Clinicians and patients will be randomized with 1:1 allocation to usual care (UC) vs. precision treatment (PT) to evaluate the effect of precision treatment on patient receipt of tobacco treatment and smoking abstinence.
In Aim 1, the investigators will develop a contextually grounded multilevel PT intervention, PrecisionTx-Onc, for oncology/hematology clinics by engaging both patients and providers. In Aim 2, the investigators will conduct a 2-arm RCT to pilot the multilevel PT intervention for feasibility and determine preliminary estimates of clinical outcomes. Preliminary data will address hypotheses that the PT vs. the UC condition will produce superior physician prescribing as measured by patient receipt of prescription, patient medication use, and patient bioverified smoking abstinence at 6 months. Additional outcomes include patient quality of life and survival.
In Aim 3, the investigators will explore mechanisms of behavior change and implementation outcomes. The investigators will explore 1) mechanisms (e.g., outcome expectancies, perceived risk/benefit, and withdrawal suppression) underlying the effect of PT, and 2) implementation outcomes to evaluate its potential for scaling, using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.
Primary outcomes include patient receipt of tobacco treatment, patient use of tobacco treatment, and patient smoking abstinence. Secondary outcomes include patient receipt of recommended medication, patient medication adherence, patient quality of life, patient survival, and additional patient smoking cessation outcomes. Mechanistic outcomes include clinician level (perceived benefit, outcome expectancy), clinician-patient interaction (self-efficacy), patient-level (perceived risk, outcome expectancy, withdrawal suppression, adverse events). Implementation outcomes will be evaluated based on the RE-AIM framework.
The study is an innovative paradigm shift from a traditional treatment model to precision treatment that includes both metabolic and genetic markers to motivate and guide tobacco treatment for both clinicians and patients, integrated within oncology care. This study will test the impact of a multilevel precision treatment intervention on improving tobacco treatment and health outcomes in oncology care.
- Conditions
- Smoking Cessation, Smoking, Physician's Role
- Being tested
- Usual care, Precision treatment
- Keywords
- Genetics, Primary Care Physicians, Tobacco Treatment
- Medical subject headings
- Smoking Cessation, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careBehavioural
Usual care will be informed by practice guidelines (standard of care, brief advice, and guideline awareness).
Precision treatmentBehavioural
Precision treatment will be informed by practice guidelines (standard of care, brief advice, and guideline awareness), plus patient-specific risk feedback and personalized tobacco treatment recommendations using patients' clinical, genetic, and biomarker information, adapted for oncology.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual care |
| PrecisionTx-Onc (oncology) | Experimental | 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. Receives: Behavioral: Precision treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient receipt of tobacco treatment medication for smoking cessation
This will be quantified by the proportion of enrolled patients who receive cessation medication.
Measured: 6 months post-intervention
Patient use of cessation medication
This will be quantified by the proportion of patients taking any cessation medication from time of enrollment through 6 months post-intervention.
Measured: 6 months post-intervention
Patient smoking abstinence
This will be quantified by the proportion of patients who smoke with bioverified point-prevalent abstinence at 6 months.
Measured: 6 months post-intervention
Secondary outcomes (8)
Patient quality of life
Quality of life measure will be measured using European Organization for Research and Treatment of Cancer Quality of life Questionnaire-Core 30 (EORTC QLQ-C30). All of the scales and single-item range in score from 0-100. A high scale score represents a higher response level. Thus, a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents high quality of life, but a high score for a symptom scale / item represents a high level of symptomatology/problems.
Measured: 6 and 12 months post-intervention
Patient survival
Probability of survival from the start of intervention
Measured: 6 and 12 months post-intervention
Patient receipt of recommended tobacco treatment
This will be quantified by the proportion of enrolled patients who received recommended cessation medication.
Measured: 6 months post-intervention
Patient medication adherence
This will be quantified by the proportion of medication taken among medication prescribed.
Measured: 6 months post-intervention
Patient smoking abstinence among treated
This will be quantified by the proportion of smokers with bioverified point-prevalence abstinence among those receiving cessation medication.
Measured: 6 months post-intervention
Abstinence Outcomes Across Multiple Time Points
The outcome measures abstinence (self-reported no smoking (not even a puff of a cigarette) for at least 7 days prior to the assessment) over these time points.
Measured: From intervention through 12 months post-intervention
Smoking quantity across multiple time points
The outcome measures smoking quantity (self-reported average cigarettes smoked per day for the past 30 days prior to the assessment) over these time points.
Measured: From intervention through 12 months post-intervention
Quit attempts
This outcome measures the number of quit attempts in the past 30 days prior to the assessment over these time points.
Measured: 6 and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start11 Sep 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization occurs at the clinician level. For pragmatic concerns, the investigators expect to recruit from multiple clinics and cluster randomization of clinicians will be stratified by clinics to minimize the clinic effect. Given the stratified randomization by clinic and the possibility of an unequal number of physicians across the 2 arms (i.e., we may not have exactly 8 in each arm), the investigators aim to recruit 8 clinicians per arm.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 132 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Li-Shiun Chen, ScD, M.D., MPH, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07166120
- Sponsor's protocol ID
- 202403025
- Other IDs
- LC230570
- Acronym
- PROMISE
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No