This clinical trial compares a standard care tobacco treatment recommendation report to a personalized precision treatment recommendation report (PrecisionTx-Onc) for improving rates of tobacco treatment and smoking cessation among cancer patients who smoke cigarettes. Persistent smoking following cancer diagnosis is common and is associated with worse survival, reduced cancer treatment effectiveness, cancer recurrence, and other tobacco-related health effects. Despite the benefits of smoking treatment in cancer patients, treatment is infrequently offered by clinicians and treatment is often not personalized to maximize effectiveness. Normally, tobacco treatment recommendations are made according to standard guidelines. PrecisionTx-Onc offers personalized precision treatment recommendations based on the patient's clinical factors, biomarkers, and genetic factors. Precision treatment recommendations may increase the rate at which patients stop smoking by matching them with treatment options tailored to their needs.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07166120.
Locations matching your search criteria
United States
Missouri
Saint Louis
Siteman Cancer Center at Washington UniversityStatus: Active
Contact: Li-Shiun Chen
Phone: 314-362-3932
PRIMARY OBJECTIVES:
I. Develop a contextually grounded multilevel precision treatment (PT) intervention for Veterans Affairs (VA) oncology clinics.
II. Conduct a 2-arm randomized controlled trial (RCT) to pilot the multilevel PT intervention for feasibility and determine preliminary estimates of clinical outcomes.
III. Explore mechanisms of behavior change and implementation outcomes.
OUTLINE:
AIM 1: Clinicians and patients participate in a focus group over 1 hour in support of adaptation of the PrecisionTx-Onc intervention on study.
PILOT: Clinicians are randomized to 1 of 2 arms. Patients are assigned to the arm to which their clinician was randomized.
ARM I: Patients undergo genetic testing. Clinicians and patients then receive a study report with recommendations for guideline-based tobacco treatment according to usual care. Patients discuss their study report with a behavioral interventionist and are encouraged to discuss tobacco treatment options with their clinicians. Clinicians are encouraged to discuss the recommendations with the patient at their next clinic visit. Patients may be prescribed varenicline or nicotine patches and lozenges at the discretion of their clinician.
ARM II: Patients undergo genetic testing. Clinicians and patients then receive a precision treatment study report that includes recommendations for guideline-based tobacco treatment according to usual care, as well as patient-specific risk feedback and personalized tobacco treatment recommendations. Patients discuss their study report with a behavioral interventionist and are encouraged to discuss tobacco treatment options with their clinicians. Clinicians are encouraged to discuss the recommendations with the patient at their next clinic visit. Patients may be prescribed varenicline or nicotine patches and lozenges at the discretion of their clinician.
After completion of study intervention, patients are followed up at 1, 3, 6, and 12 months.
Trial PhaseNo phase specified
Trial Typeprevention
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorLi-Shiun Chen
