Smoking Cessation
Conditions
Brief summary
The proposed study will test a medication plus text messaging intervention specifically designed for lung cancer screening patients. Half of the patients will receive standard of care, and half will receive the treatment intervention.
Detailed description
Screening for lung cancer at earlier, more treatable stages has the potential to reduce mortality from the U.S.'s most deadly cancer. Annual lung cancer screening with low-dose computed tomography is now recommended for high risk individuals based on age and smoking history. This study will evaluate a smoking cessation intervention for lung cancer screening patients. We will evaluate quit rates after a standard intervention (brief counseling session at time of lung cancer screening) versus a dual nicotine replacement therapy (NRT) and gain-framed text messaging intervention.
Interventions
BEHAVIORALText messaging plus nicotine replacement therapy
Brief advice to quit smoking prior to lung cancer screening (LCS), 8 weeks of gain-framed, LCS-tailored text messages, and nicotine replacement therapy.
OTHERStandard Care at Lung Cancer Screening
Brief advice to quit smoking prior to lung cancer screening
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion: 1. 55 years or older 2. 30 pack year history of smoking 3. current smoker (defined as breath carbon monoxide\>6ppm) 4. willing to be randomized 5. English speaking Exclusion: 1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, substance abuse, or dementia 2. in the immediate (within 2 weeks) post myocardial infarction period 3. serious arrhythmias 4. unstable angina pectoris 5. hemodynamically or electrically unstable 6. currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking NRT or other cessation medications, enrolled in the Quitline, in another drug study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| End of Treatment Abstinence Rates | Week 8 (end of treatment) | 7-day point prevalence abstinence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| End of Study Abstinence Rates | 3-month follow-up | Effect size estimates at End of Study |
Countries
United States
Participant flow
Pre-assignment details
48 participants were consented in to the study, but 7 withdrew before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Advice to quit and brief discussion of tobacco use plus dual nicotine replacement therapy plus 8 weeks of gain-framed text messages tailored to lung cancer screening patients
Text messaging plus nicotine replacement therapy: Brief advice to quit smoking prior to lung cancer screening (LCS), 8 weeks of gain-framed, LCS-tailored text messages, and nicotine replacement therapy. | 21 |
| Standard Care Advice to quit and brief discussion of tobacco use
Standard Care at Lung Cancer Screening: Brief advice to quit smoking prior to lung cancer screening | 19 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Treatment Arm | Standard Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 8 Participants | 19 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 11 Participants | 21 Participants |
| Age, Continuous | 65.4 years STANDARD_DEVIATION 6.1 | 63.4 years STANDARD_DEVIATION 6.3 | 64.4 years STANDARD_DEVIATION 6.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants | 19 Participants | 40 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 8 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 11 Participants | 26 Participants |
| Region of Enrollment United States | 21 participants | 19 participants | 40 participants |
| Sex: Female, Male Female | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 19 |
| other Total, other adverse events | 0 / 21 | 0 / 19 |
| serious Total, serious adverse events | 0 / 21 | 0 / 19 |
Outcome results
Primary
End of Treatment Abstinence Rates
7-day point prevalence abstinence
Time frame: Week 8 (end of treatment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | End of Treatment Abstinence Rates | 3 Participants |
| Standard Care | End of Treatment Abstinence Rates | 0 Participants |
Secondary
End of Study Abstinence Rates
Effect size estimates at End of Study
Time frame: 3-month follow-up
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Treatment Arm | End of Study Abstinence Rates | 1 Participants |
| Standard Care | End of Study Abstinence Rates | 0 Participants |