PRecision Interventions for SMoking in the SCCS
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Smoking Cessation |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | May 18, 2018 |
| End Date: | August 1, 2019 |
Developing Precision Smoking Treatment in the Southern Community Cohort Study
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.
(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.
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
(i.e., information on nicotine metabolism or lung cancer risk). After receiving lab results,
participants will complete a final brief questionnaire.
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
(i.e., information on nicotine metabolism or lung cancer risk). After receiving lab results,
participants will complete a final brief questionnaire.
Inclusion Criteria:
- Daily smoker of ≥5 cigarettes per day (CPD)
- Enrolled participant of the Southern Community Cohort Study (SCCS) who completed a
prior survey indicating they were willing to be contacted regarding a smoking
cessation clinical trial
- Residence in Tennessee (TN) or Mississippi (MS)
- Has stored blood sample with the SCCS
- Has established primary care provider (PCP)
- Medically eligible and willing to take varenicline and NRT
Exclusion Criteria:
- Currently taking medication to quit smoking
- enrolled, or planning to be enrolled, in another smoking cessation program
- Inability to give informed consent or participate due to cognitive disorder (e.g.,
dementia, severe intellectual disability)
- Unstable psychiatric illness (ER or hospitalized for psychiatric condition in past 6
months, change in psychiatric medications in past 3 months, or suicidal ideation in
past 6 months)
- not able to send or receive mail
- no access to a telephone or inability to communicate by telephone
- unable to speak and read English
- history of seizures or Buerger's disease
- currently pregnant or breastfeeding
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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