Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-11

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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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

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Smoking Cessation Smoking Physician's Role

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care

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 Type ACTIVE_COMPARATOR

Usual care

Intervention Type BEHAVIORAL

Usual care will be informed by practice guidelines (standard of care, brief advice, and guideline awareness).

PrecisionTx-Onc (oncology)

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 Type EXPERIMENTAL

Precision treatment

Intervention Type BEHAVIORAL

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.

Interventions

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Usual care

Usual care will be informed by practice guidelines (standard of care, brief advice, and guideline awareness).

Intervention Type BEHAVIORAL

Precision treatment

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No