Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Usual care, Precision treatment.
- Who it may be relevant to
- Registry conditions: Smoking Cessation, Smoking, Physician's Role. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Interventions
- Behavioral Usual care
Usual care will be informed by practice guidelines (standard of care, brief advice, and guideline awareness). - 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.
Primary outcome measures
- Patient receipt of tobacco treatment medication for smoking cessation [Time frame: 6 months post-intervention]
- Patient use of cessation medication [Time frame: 6 months post-intervention]
- Patient smoking abstinence [Time frame: 6 months post-intervention]
Secondary outcome measures (8)
- Patient quality of life [Time frame: 6 and 12 months post-intervention]
- Patient survival [Time frame: 6 and 12 months post-intervention]
- Patient receipt of recommended tobacco treatment [Time frame: 6 months post-intervention]
- Patient medication adherence [Time frame: 6 months post-intervention]
- Patient smoking abstinence among treated [Time frame: 6 months post-intervention]
- Abstinence Outcomes Across Multiple Time Points [Time frame: From intervention through 12 months post-intervention]
- Smoking quantity across multiple time points [Time frame: From intervention through 12 months post-intervention]
- Quit attempts [Time frame: 6 and 12 months post-intervention]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Prevention
Study locations
United States · 2 centers
- John Cochran Veteran's Affairs Medical Center — St Louis
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT07166120 · 202403025 · LC230570