This trial tests how well personalized multilevel interventions using patient specific risk feedback and personalized tobacco treatment recommendations works compared to usual care to improve tobacco treatment in primary care for patients who are currently smoking. Smoking cessation significantly reduces the risk of premature death however, smoking cessation success is limited by a cascade of factors, including a low rate of clinician prescription of cessation medication, a low rate of patient use of cessation medication, and limited medication effectiveness despite available treatment, practice guidelines, and considerable implementation effort with clinician and patients. Precision treatment based on genetic testing may increase treatment effectiveness by matching patients who smoke with the medication that maximizes efficacy and safety, it may increase clinicians’ likelihood of prescribing because they expect precision treatment to be more effective than standard treatment and it may increase patients’ motivation to initiate and adhere to cessation medication, as evidence suggests that patients who smoke express desire for gene-guided treatment and increased motivation to use it.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05846841.
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. Evaluate the impact of the multilevel precision treatment intervention on clinician prescribing and patient use of medication for smoking cessation.
II. Evaluate the impact of precision treatment on patient smoking abstinence.
III. Evaluate mechanisms of behavior change and implementation outcomes.
OUTLINE: Clinicians are randomized to 1 of 2 arms. Patients are assigned to the same arm as their clinician.
ARM I: Patients complete genetic testing and complete an interview at visit 1, patients receive and share genetic testing results report if available at visit 2, patients then receive standard of care education, consisting of brief advice and guideline awareness, as well as patient specific feedback and personalized tobacco treatment recommendations based on their genetic testing and complete an interview at visit 3. Patients complete an interview at visit 4.
ARM II: Patients complete genetic testing at visit 1, patients receive and share genetic testing results report if available at visit 2, patients then receive standard of care education, consisting of brief advice and guideline awareness, at visit 3. Patients complete an interview at visit 4. .
After completion of study intervention, patients are followed up at 3, 6 and 12 months post visit 3.
Trial PhaseNo phase specified
Trial Typetreatment
Lead OrganizationSiteman Cancer Center at Washington University
Principal InvestigatorLi-Shiun Chen
