Precision Treatment to Promote Smoking Cessation and Survival in Oncology Patients

NCT07166120 | Recruiting DMC

• 2 other identifiers: 202403025LC230570
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Smoking Cessation; Smoking; Physician's Role

Keywords

Genetics; Primary Care Physicians; Tobacco Treatment

Outcome Measures

Primary Outcomes (3)

• Patient receipt of tobacco treatment medication for smoking cessation

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

  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.

  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.

  6 months post-intervention

Secondary Outcomes (8)

• Patient quality of life

  6 and 12 months post-intervention

• Patient survival

  6 and 12 months post-intervention

• Patient receipt of recommended tobacco treatment

  6 months post-intervention

• Patient medication adherence

  6 months post-intervention

• Patient smoking abstinence among treated

  6 months post-intervention

Study Arms (2)

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.

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.

Behavioral: Precision treatment

Interventions

Usual care BEHAVIORAL

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

Usual Care

Precision treatment 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.

PrecisionTx-Onc (oncology)

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Washington University School of Medicine: lead
• United States Department of Defense: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Smoking Cessation; Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Li-Shiun Chen, ScD, M.D., MPH

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

314-362-3932; li-shiun@wustl.edu

Theodore Thomas, M.D.

CONTACT

thomast@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 10, 2025
• Study Start: September 11, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: October 30, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)