Cancer, Smoking Cessation
Conditions
Brief summary
This pilot comparative effectiveness trial will compare two active smoking cessation treatments in terms of effectiveness, equity across patient subpopulations, and efficiency among adult patients diagnosed with cancer within the past 3 years. An enhanced treatment comprising 12 weeks of varenicline treatment and 7 smoking cessation coaching calls with a cancer focus will be compared against an active comparator modeled after standard quitline treatments (2 weeks of nicotine patch therapy with 3 phone coaching calls). Approximately 50 participants will be recruited to generate estimates of the effects, acceptability, costs, and equity of enhanced treatment (vs. standard treatment), with the primary outcome being abstinence from smoking 26 weeks after trying to quit.
Detailed description
Primary Aim 1\. To generate estimates of the size of the comparative effects of enhanced, cancer-specific smoking cessation treatment versus a generic standard care package similar to quitline care in terms of biochemically confirmed 7-day point prevalence abstinence (no smoking in the past 7 days) 26 weeks after a target quit date. Exploratory Aims 1. To estimate differences in CET arms in exploratory outcomes including patient acceptability, completion, adherence, costs, and cost-effectiveness. 2. To estimate the extent to which treatment effects on abstinence and exploratory outcomes differ across patient subpopulations based on demographics (age, race, sex, ethnicity, socioeconomic disadvantage); nicotine dependence; and cancer site, stage, and treatment phase.
Interventions
DRUGTransdermal Nicotine Patch
a stop smoking aid, 21 milligrams(mg), 14mg, or 7mg of nicotine delivered over 24 hours
BEHAVIORALStandard Telephone Counseling
3 brief telephone-based smoking cessation counseling sessions
DRUGVarenicline
12 weeks of an oral smoking cessation medication
BEHAVIORALCancer-Targeted Telephone Counseling
7 telephone-based smoking cessation counseling sessions adapted for cancer patients
OTHERMailed Information about Standard Care Resources
Publicly funded treatment resources including the SmokefreeTXT program sponsored by the National Cancer Institute and the Wisconsin Tobacco Quit Line.
Sponsors
National Cancer Institute (NCI)
University of Wisconsin, Madison
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
* Alive (per medical record) * Diagnosed with cancer in the past 3 years * Received care from a participating oncology clinic in the past year * Has a current tobacco use status * Does not have a preferred language other than English (missing language preference will be included). * Valid address that is not a correctional facility or residential treatment/care facility. * No flag for patient cognitive impairment, activated health care power of attorney, or other health care agent (e.g., legally authorized representative) in the EHR. The following additional inclusion criteria must be met for inclusion in the CET * Smoked combustible cigarettes in the past month. * Able to speak and understand English. * Willing to set a date to quit smoking in the next 60 days. * Willing to receive smoking treatment information. * Willing to complete study activities.
Exclusion criteria
* No current suicidal ideation. * Suicide attempt in the past year. * Currently receiving treatment for bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder. * Incarceration. * Unable to provide informed consent to treatment (i.e., cannot answer questions about study procedures or risks after hearing about the study).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date. | up to 30 weeks post target quit date | This measure is confirmed by expired carbon monoxide and/or a cotinine urine or saliva sample test. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 7-day Point-prevalence Abstinence 12 Weeks After a Target Quit Date. | up to 13 weeks post target quit date | This measure is a self-report response at the 12 week telephone follow-up to the question Have you smoked, even a puff, in the last 7 days?. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low-Intensity Standard Smoking Cessation Treatment 2 weeks of nicotine patch therapy, 3 telephone counseling sessions, and information about quitline and National Cancer Institute text messaging support services (SmokefreeTXT)
Transdermal Nicotine Patch: a stop smoking aid, 21 milligrams(mg), 14mg, or 7mg of nicotine delivered over 24 hours
Standard Telephone Counseling: 3 brief telephone-based smoking cessation counseling sessions
Mailed Information about Standard Care Resources: Publicly funded treatment resources including the SmokefreeTXT program sponsored by the National Cancer Institute and the Wisconsin Tobacco Quit Line. | 26 |
| High-Intensity, Cancer-Targeted Smoking Cessation Treatment 12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services
Varenicline: 12 weeks of an oral smoking cessation medication
Cancer-Targeted Telephone Counseling: 7 telephone-based smoking cessation counseling sessions adapted for cancer patients
Mailed Information about Standard Care Resources: Publicly funded treatment resources including the SmokefreeTXT program sponsored by the National Cancer Institute and the Wisconsin Tobacco Quit Line. | 26 |
| Total | 52 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 0 |
| Overall Study | Lost to Follow-up | 0 | 2 |
Baseline characteristics
| Characteristic | Low-Intensity Standard Smoking Cessation Treatment | High-Intensity, Cancer-Targeted Smoking Cessation Treatment | Total |
|---|---|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 6.9 | 61.8 years STANDARD_DEVIATION 8.3 | 64.0 years STANDARD_DEVIATION 7.8 |
| 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 | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 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 | 24 Participants | 23 Participants | 47 Participants |
| Region of Enrollment United States | 26 participants | 26 participants | 52 participants |
| Sex/Gender, Customized Gender Female | 11 Participants | 15 Participants | 26 Participants |
| Sex/Gender, Customized Gender Male | 14 Participants | 10 Participants | 24 Participants |
| Sex/Gender, Customized Gender Other | 1 Participants | 1 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 26 | 0 / 26 |
| other Total, other adverse events | 4 / 26 | 8 / 26 |
| serious Total, serious adverse events | 8 / 26 | 6 / 26 |
Outcome results
Primary
Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date.
This measure is confirmed by expired carbon monoxide and/or a cotinine urine or saliva sample test.
Time frame: up to 30 weeks post target quit date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-Intensity Standard Smoking Cessation Treatment | Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date. | 2 Participants |
| High-Intensity, Cancer-Targeted Smoking Cessation Treatment | Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date. | 7 Participants |
Secondary
Self-reported 7-day Point-prevalence Abstinence 12 Weeks After a Target Quit Date.
This measure is a self-report response at the 12 week telephone follow-up to the question Have you smoked, even a puff, in the last 7 days?.
Time frame: up to 13 weeks post target quit date
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low-Intensity Standard Smoking Cessation Treatment | Self-reported 7-day Point-prevalence Abstinence 12 Weeks After a Target Quit Date. | 6 Participants |
| High-Intensity, Cancer-Targeted Smoking Cessation Treatment | Self-reported 7-day Point-prevalence Abstinence 12 Weeks After a Target Quit Date. | 9 Participants |