Smoking Cessation
Conditions
Brief summary
This is a smoking cessation treatment study. Patients who have a cancer or a suspected cancer who will undergo surgical removal of their cancer are eligible to participate in this study. A novel smoking cessation treatment will be provided to half of the participants in the study. All study participants will receive standard smoking cessation therapy including counseling and the nicotine patch.
Interventions
COMBINATION_PRODUCTContingency Management
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test.
COMBINATION_PRODUCTStandard Care
Participants will receive 3-6 counseling sessions, nicotine patches \& lozenges, and CO breath test monitoring.
Sponsors
Medical University of South Carolina
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 or older 2. smoking 1 or more combustible tobacco products per day 3. diagnosed with or suspicion of any type of operable cancer
Exclusion criteria
1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, or dementia 2. non-English speaking 3. use of alternative nicotine delivery systems (e.g., e-cigarettes, snus, etc) 4. pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence Rates as Assessed by Self-report for Past 7 Days, Carbon Monoxide Breath Monitoring and/or Anabasine Testing | Changes between the study intake appointment to day of surgery, up to five weeks apart | Abstinence will be defined by 7 days by self-report of no tobacco products, confirmed by CO breath test less than or equal to 4ppm and/or urine anabasine levels less than or equal to 2 ng/ml |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Abstinence Rates as Assessed by Self-report for Past 7 Days, Carbon Monoxide Breath Monitoring and/or Anabasine Testing | Three months after surgery date | Abstinence will be defined by 7 days by self-report of no tobacco products, confirmed by CO breath test less than or equal to 4ppm and/or urine anabasine levels less than or equal to 2 ng/ml |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORBenjamin Toll
Medical University of South Carolina
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.4 years STANDARD_DEVIATION 10.7 |
| Cigarettes Smokerd Per day, mean | 15 CPD STANDARD_DEVIATION 8.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 140 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 69 Participants |
| Race (NIH/OMB) More than one race | 7 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 107 Participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 60 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 5 / 139 | 4 / 143 |
| other Total, other adverse events | 0 / 139 | 0 / 143 |
| serious Total, serious adverse events | 5 / 139 | 4 / 143 |
Outcome results
None listed