Trial Outcomes & Findings for Tobacco Treatment Comparison for Cancer Care (NCT NCT06218823)
NCT ID: NCT06218823
Last Updated: 2025-10-27
Results Overview
This measure is confirmed by expired carbon monoxide and/or a cotinine urine or saliva sample test.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
52 participants
Primary outcome timeframe
up to 30 weeks post target quit date
Results posted on
2025-10-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
26
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Tobacco Treatment Comparison for Cancer Care
Baseline characteristics by cohort
| Measure |
High-Intensity, Cancer-Targeted Smoking Cessation Treatment
n=26 Participants
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.
|
Total
n=52 Participants
Total of all reporting groups
|
Low-Intensity Standard Smoking Cessation Treatment
n=26 Participants
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.
|
|---|---|---|---|
|
Age, Continuous
|
61.8 years
STANDARD_DEVIATION 8.3 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
66.2 years
STANDARD_DEVIATION 6.9 • n=5 Participants
|
|
Sex/Gender, Customized
Gender · Female
|
15 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
11 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Male
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
14 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender · Other
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=7 Participants
|
52 participants
n=5 Participants
|
26 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 30 weeks post target quit dateThis measure is confirmed by expired carbon monoxide and/or a cotinine urine or saliva sample test.
Outcome measures
| Measure |
Low-Intensity Standard Smoking Cessation Treatment
n=26 Participants
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.
|
High-Intensity, Cancer-Targeted Smoking Cessation Treatment
n=26 Participants
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.
|
|---|---|---|
|
Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date.
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: up to 13 weeks post target quit dateThis 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?".
Outcome measures
| Measure |
Low-Intensity Standard Smoking Cessation Treatment
n=26 Participants
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.
|
High-Intensity, Cancer-Targeted Smoking Cessation Treatment
n=26 Participants
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.
|
|---|---|---|
|
Self-reported 7-day Point-prevalence Abstinence 12 Weeks After a Target Quit Date.
|
6 Participants
|
9 Participants
|
Adverse Events
Low-Intensity Standard Smoking Cessation Treatment
Serious events: 8 serious events
Other events: 4 other events
Deaths: 3 deaths
High-Intensity, Cancer-Targeted Smoking Cessation Treatment
Serious events: 6 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Low-Intensity Standard Smoking Cessation Treatment
n=26 participants at risk
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.
|
High-Intensity, Cancer-Targeted Smoking Cessation Treatment
n=26 participants at risk
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.
|
|---|---|---|
|
General disorders
Death
|
11.5%
3/26 • Number of events 3 • Adverse event data were collected from baseline until 26 weeks.
|
0.00%
0/26 • Adverse event data were collected from baseline until 26 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization
|
7.7%
2/26 • Number of events 2 • Adverse event data were collected from baseline until 26 weeks.
|
0.00%
0/26 • Adverse event data were collected from baseline until 26 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hospitalization
|
0.00%
0/26 • Adverse event data were collected from baseline until 26 weeks.
|
3.8%
1/26 • Number of events 2 • Adverse event data were collected from baseline until 26 weeks.
|
|
Renal and urinary disorders
Hospitalization
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected from baseline until 26 weeks.
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected from baseline until 26 weeks.
|
|
Cardiac disorders
Hospitalization
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected from baseline until 26 weeks.
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected from baseline until 26 weeks.
|
|
General disorders
Hospitalization
|
3.8%
1/26 • Number of events 2 • Adverse event data were collected from baseline until 26 weeks.
|
11.5%
3/26 • Number of events 3 • Adverse event data were collected from baseline until 26 weeks.
|
|
Gastrointestinal disorders
Hospitalization
|
0.00%
0/26 • Adverse event data were collected from baseline until 26 weeks.
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected from baseline until 26 weeks.
|
Other adverse events
| Measure |
Low-Intensity Standard Smoking Cessation Treatment
n=26 participants at risk
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.
|
High-Intensity, Cancer-Targeted Smoking Cessation Treatment
n=26 participants at risk
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.
|
|---|---|---|
|
Nervous system disorders
Nausea
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected from baseline until 26 weeks.
|
11.5%
3/26 • Number of events 5 • Adverse event data were collected from baseline until 26 weeks.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
11.5%
3/26 • Number of events 3 • Adverse event data were collected from baseline until 26 weeks.
|
3.8%
1/26 • Number of events 1 • Adverse event data were collected from baseline until 26 weeks.
|
|
Psychiatric disorders
Vivid Dreams
|
0.00%
0/26 • Adverse event data were collected from baseline until 26 weeks.
|
15.4%
4/26 • Number of events 4 • Adverse event data were collected from baseline until 26 weeks.
|
Additional Information
Associate Director of Research
University of Wisconsin Center for Tobacco Research and Intervention
Phone: 6082628673
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place