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Precision Tobacco Treatment for Smoking Cessation in Oncology Patients

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What is being tested

Usual care

+ Precision treatment
Behavioral
Who is being recruted

Smoking Cessation

+ Smoking
+ Physician's Role
From 18 to 89 Years

See all eligibility criteria

How is the trial designed

Prevention Study

Interventional
Study Start: September 2025

See protocol details

Summary

Principal SponsorWashington University School of Medicine
Study ContactLi-Shiun Chen, ScD, M.D., MPH
Last updated: October 30, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: September 11, 2025Actual date on which the first participant was enrolled.

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 the most effective and safest smoking cessation medication tailored just for them. The study involves cancer patients and their doctors, aiming to improve how often doctors recommend and patients use these treatments. This approach is important because quitting smoking can significantly improve a cancer patient's quality of life and survival. By integrating this personalized treatment into cancer care, the study hopes to enhance the effectiveness of smoking cessation efforts. In the study, doctors and their cancer patients are divided into two groups: one receiving standard care and the other receiving the personalized precision treatment. This personalized treatment involves sharing specific risks, benefits, and treatment recommendations with each patient to encourage them to follow through with quitting smoking. The study measures success by looking at how many patients receive and use the tobacco treatments, as well as how many successfully quit smoking. Other aspects such as the patients' quality of life and survival are also monitored. The study also examines how the personalized approach influences both doctors' and patients' attitudes towards smoking cessation and the overall implementation of the treatment.

Official TitlePrecision Treatment to Promote Smoking Cessation and Survival in Oncology Patients 
Principal SponsorWashington University School of Medicine
Study ContactLi-Shiun Chen, ScD, M.D., MPH
Last updated: October 30, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
112 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 89 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Smoking Cessation
Smoking
Physician's Role
Criteria

Eligibility Criteria for Clinicians: * Clinician from participating oncology/hematology clinic * At least 18 years of age * Can speak and understand English Inclusion Criteria for Patients: * 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 Exclusion Criteria for Patients: * 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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
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.
Group II
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.
Study Objectives
Primary Objectives

This will be quantified by the proportion of enrolled patients who receive cessation medication.

This will be quantified by the proportion of patients taking any cessation medication from time of enrollment through 6 months post-intervention.

This will be quantified by the proportion of patients who smoke with bioverified point-prevalent abstinence at 6 months.
Secondary Objectives

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.

Probability of survival from the start of intervention

This will be quantified by the proportion of enrolled patients who received recommended cessation medication.

This will be quantified by the proportion of medication taken among medication prescribed.

This will be quantified by the proportion of smokers with bioverified point-prevalence abstinence among those receiving cessation medication.

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.

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.

This outcome measures the number of quit attempts in the past 30 days prior to the assessment over these time points.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
Washington University School of MedicineSt Louis, United StatesSee the location
Recruiting
One Study Center