Lung Cancer Screening, Smoking Cessation
Conditions
Brief summary
This research is a randomized smoking cessation trial conducted within and specifically personalized for lung cancer screening patients presenting to a lung screening clinic. Novel tobacco treatments for this population are critically needed, given the growing population of lung screening patients, which will grow dramatically now that lung screening is an approved CMS benefit. In the proposed study, we will test a gain-framed messaging intervention specifically designed for lung screening patients (vs. unframed messaging), as well as evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be translational (in that it can be transferable from our controlled efficacy study to other lung screening programs).
Interventions
BEHAVIORALGain-framed messaging
Gain-framed messaging materials
COMBINATION_PRODUCTUnframed messaging materials
Unframed smoking cessation materials
Sponsors
National Cancer Institute (NCI)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 50 years or older 2. at least a 20-pack year history of smoking 3. current smoker (defined as any smoking in the past 30 days) 4. willing to be randomized 5. English speaking
Exclusion criteria
1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia, 2. known allergy to adhesives 3. being in the immediate (within 2 weeks) post myocardial infarction period 4. serious arrhythmias 5. unstable angina pectoris 6. hemodynamically or electrically unstable. 7. current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking Cessation - Available Data | 6 month follow-up | Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cigarettes Smoked Per Day - Average | 6 month follow-up | Gain-framed messaging vs. Unframed messaging - average reported cigarettes smoked per day. |
| Smoking Cessation - Imputed | 6 Month Follow up Visit | Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit. Missing participant data imputed to no cessation. 3 participants from the unframed group were not included as they had died prior to the 6-month visit. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Unframed Messaging Unframed smoking cessation materials
Unframed messaging materials: Unframed smoking cessation materials | 183 |
| Gain-framed Messaging Gain-framed messaging
Gain-framed messaging: Gain-framed messaging materials | 184 |
| Total | 367 |
Baseline characteristics
| Characteristic | Unframed Messaging | Gain-framed Messaging | Total |
|---|---|---|---|
| Abstinent at Study Baseline | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 56 Participants | 69 Participants | 125 Participants |
| Age, Categorical Between 18 and 65 years | 127 Participants | 115 Participants | 242 Participants |
| Age, Continuous | 62.2 Years STANDARD_DEVIATION 5.6 | 62.7 Years STANDARD_DEVIATION 6 | 62.4 Years STANDARD_DEVIATION 5.8 |
| Cigarettes Smoked Per Day | 15.6 Cigarettes Smoked Per Day, Average STANDARD_DEVIATION 7.8 | 15.6 Cigarettes Smoked Per Day, Average STANDARD_DEVIATION 8.2 | 15.6 Cigarettes Smoked Per Day, Average STANDARD_DEVIATION 8 |
| Race (NIH/OMB) American Indian or Alaska Native | 4 Participants | 4 Participants | 8 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 66 Participants | 56 Participants | 122 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants | 8 Participants | 19 Participants |
| Race (NIH/OMB) White | 102 Participants | 115 Participants | 217 Participants |
| Region of Enrollment United States | 183 participants | 184 participants | 367 participants |
| Sex: Female, Male Female | 108 Participants | 102 Participants | 210 Participants |
| Sex: Female, Male Male | 75 Participants | 82 Participants | 157 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 183 | 0 / 184 |
| other Total, other adverse events | 0 / 183 | 0 / 184 |
| serious Total, serious adverse events | 0 / 183 | 0 / 184 |
Outcome results
Primary
Smoking Cessation - Available Data
Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit
Time frame: 6 month follow-up
Population: All available participants are included in the analysis of 7 day point prevalence abstinence at the 6-month follow up visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unframed Messaging | Smoking Cessation - Available Data | 15 Participants |
| Gain-framed Messaging | Smoking Cessation - Available Data | 19 Participants |
Secondary
Cigarettes Smoked Per Day - Average
Gain-framed messaging vs. Unframed messaging - average reported cigarettes smoked per day.
Time frame: 6 month follow-up
Population: all participants with data available at the 6-month follow up visit.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Unframed Messaging | Cigarettes Smoked Per Day - Average | 9.7 Average Cigarettes Smoked Per Day |
| Gain-framed Messaging | Cigarettes Smoked Per Day - Average | 8.9 Average Cigarettes Smoked Per Day |
Secondary
Smoking Cessation - Imputed
Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit. Missing participant data imputed to no cessation. 3 participants from the unframed group were not included as they had died prior to the 6-month visit.
Time frame: 6 Month Follow up Visit
Population: all randomized participants whom were alive at the 6-month follow up visit.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Unframed Messaging | Smoking Cessation - Imputed | 15 Participants |
| Gain-framed Messaging | Smoking Cessation - Imputed | 19 Participants |