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PRecision Interventions for SMoking in the SCCS (PRISM-SCCS)
Precision Care (PC) interventions, developed with guidance from a Community Advisory Board (CAB), will be piloted in a Randomized Clinical Trial (RCT) of approximately 100 eligible, consenting daily smokers in the Southern Community Cohort Study (SCCS) who are willing to make a quit attempt with medication and who reside in TN or MS. Participants will be randomized 1:1:1 to 1 of 3 groups; (1) group one informs selection of medication with information on nicotine metabolism; (2) group two offers a genetically-informed lung cancer risk score, and (3) group 3 is Guideline-Based Care (GBC). All groups will be followed for 6 months. All RCT participants will receive FDA-approved smoking cessation medication, be referred to the shared TN/MS state quitline, and be offered the NCI "Clearing the Air" standard intervention. The primary outcome is feasibility of delivering the precision interventions in the SCCS population, as evidenced by ability to recruit, engage, and retain participants through end of study. Secondary outcomes, for which the study is not powered, will include risk perceptions, use of quit aids, lung cancer screening among those who are eligible, and smoking cessation.
Details
| Lead sponsor | Vanderbilt University Medical Center |
|---|---|
| Phase | PHASE2, PHASE3 |
| Status | COMPLETED |
| Enrolment | 67 |
| Start date | Fri May 18 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Apr 25 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Tobacco Use Cessation
Interventions
- Nicotine patch
- Varenicline
- Nicotine metabolism
- Genetically-informed lung cancer risk score
- NCI "Clearing the Air"
Countries
United States