Ignite Creation Date:
2024-05-06 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 12:45 PM
Study NCT ID:
NCT03521141
Status:
COMPLETED
Last Update Posted:
2020-06-01
First Post:
2018-04-27
Brief Title:
PRecision Interventions for SMoking in the SCCS
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Developing Precision Smoking Treatment in the Southern Community Cohort Study
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRISM-SCCS
Brief Summary:
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 111 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 TNMS 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
Detailed Description:
Cigarette smoking significantly increases the risk of cancer and improved cessation strategies are needed Biologically-informed precision treatment could benefit smokers but is understudied
Tennessee and Mississippi Smokers that responded to a previous survey indicating willingness to be contacted for a smoking cessation clinical trial will be assessed for eligibility via phone and if eligible provide verbal consent and administer a baseline survey These participants will then mail in written consent upon receipt of which their SCCS stored blood samples will be analyzed During lab processing a study tobacco counselor will call enrolled participants to assist with their quit plan and inform them of randomization status Participants will complete telephone surveys at 1 3 and 6 months During the 6 month follow-up call participants will also be given their previously-unreported lab results ie information on nicotine metabolism or lung cancer risk After receiving lab results participants will complete a final brief questionnaire
Tennessee and Mississippi Smokers that responded to a previous survey indicating willingness to be contacted for a smoking cessation clinical trial will be assessed for eligibility via phone and if eligible provide verbal consent and administer a baseline survey These participants will then mail in written consent upon receipt of which their SCCS stored blood samples will be analyzed During lab processing a study tobacco counselor will call enrolled participants to assist with their quit plan and inform them of randomization status Participants will complete telephone surveys at 1 3 and 6 months During the 6 month follow-up call participants will also be given their previously-unreported lab results ie information on nicotine metabolism or lung cancer risk After receiving lab results participants will complete a final brief questionnaire
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| HS2016-3815 | OTHER | Tennessee State University | None |
| 16-06-571 | OTHER | None | None |