Trial Outcomes & Findings for Tobacco Use Treatment in Cancer Patients (NCT NCT03482583)
NCT ID: NCT03482583
Last Updated: 2020-05-22
Results Overview
Using intent-to-treat analysis, 3 (7.7%) PhoneQuit, 2 (5.4%) SmartQuit, and 2 (14.3%) GroupQuit patients reported 7-day point prevalence abstinence from smoking. Smart Quit abstinence was verified with CO readings.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
90 participants
Primary outcome timeframe
12 weeks
Results posted on
2020-05-22
Participant Flow
Participant milestones
| Measure |
Cognitive Behavior Therapy With NRT
Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.
Nicotine Replacement Therapy: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform.
|
Referral to Area Health Education Center
The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
Referral to Qutiline
Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use.
The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
14
|
39
|
|
Overall Study
COMPLETED
|
12
|
5
|
18
|
|
Overall Study
NOT COMPLETED
|
25
|
9
|
21
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tobacco Use Treatment in Cancer Patients
Baseline characteristics by cohort
| Measure |
Cognitive Behavior Therapy With NRT
n=37 Participants
Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.
Nicotine Replacement Therapy: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform.
|
Referral to Area Health Education Center
n=14 Participants
The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
Referral to Qutiline
n=39 Participants
Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use.
The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 13.1 • n=93 Participants
|
57.3 years
STANDARD_DEVIATION 6.9 • n=4 Participants
|
60.6 years
STANDARD_DEVIATION 1.2 • n=27 Participants
|
58.0 years
STANDARD_DEVIATION 10.2 • n=483 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=93 Participants
|
10 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
50 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
40 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
88 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
White
|
29 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
68 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
5 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
90 Participants
n=483 Participants
|
|
Rurality
Urban
|
26 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
62 Participants
n=483 Participants
|
|
Rurality
Rural
|
11 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
28 Participants
n=483 Participants
|
|
Cigarette Smoking Frequency
Every Day
|
34 Participants
n=93 Participants
|
13 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
77 Participants
n=483 Participants
|
|
Cigarette Smoking Frequency
Some Days
|
3 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
10 Participants
n=483 Participants
|
|
Cigarette Smoking Frequency
Declined to answer
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
3 Participants
n=483 Participants
|
|
E-Cigarette Use Frequency
Every Day
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
6 Participants
n=483 Participants
|
|
E-Cigarette Use Frequency
Some Days
|
6 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
E-Cigarette Use Frequency
Not at All
|
27 Participants
n=93 Participants
|
11 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
65 Participants
n=483 Participants
|
|
E-Cigarette Use Frequency
Declined to Answer
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Cigarettes/Day
|
13.8 Cigarettes/day
STANDARD_DEVIATION 12.1 • n=93 Participants
|
20.1 Cigarettes/day
STANDARD_DEVIATION 15.1 • n=4 Participants
|
12.3 Cigarettes/day
STANDARD_DEVIATION 8.5 • n=27 Participants
|
14.2 Cigarettes/day
STANDARD_DEVIATION 11.5 • n=483 Participants
|
|
Age of Smoking Initiation
|
16.2 years
STANDARD_DEVIATION 6.4 • n=93 Participants
|
21.0 years
STANDARD_DEVIATION 8.1 • n=4 Participants
|
18.9 years
STANDARD_DEVIATION 6.2 • n=27 Participants
|
17.0 years
STANDARD_DEVIATION 8.0 • n=483 Participants
|
|
Patient Exit Interview (PEI)
|
7.7 units on a scale
STANDARD_DEVIATION 2.6 • n=93 Participants
|
6.9 units on a scale
STANDARD_DEVIATION 2.9 • n=4 Participants
|
7.2 units on a scale
STANDARD_DEVIATION 2.9 • n=27 Participants
|
7.4 units on a scale
STANDARD_DEVIATION 2.7 • n=483 Participants
|
|
Cancer Diagnosis
Past Week
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Cancer Diagnosis
Past Month
|
5 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Cancer Diagnosis
Past 1-3 Months
|
4 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
14 Participants
n=483 Participants
|
|
Cancer Diagnosis
Past 4-6 Months
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
17 Participants
n=483 Participants
|
|
Cancer Diagnosis
Past 7-12 Months
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Cancer Diagnosis
Over 12 Months
|
16 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
17 Participants
n=27 Participants
|
38 Participants
n=483 Participants
|
|
Cancer Site
Lung
|
11 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
26 Participants
n=483 Participants
|
|
Cancer Site
Head and Neck
|
20 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
|
Cancer Site
Breast
|
7 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
13 Participants
n=483 Participants
|
|
Cancer Site
Gastrointestinal
|
5 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
21 Participants
n=483 Participants
|
|
Cancer Site
Thyroid
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
|
Cancer Site
Genitourinary
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
12 Participants
n=483 Participants
|
|
Cancer Site
Gynecologic
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
|
Cancer Site
Bone
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Cancer Site
Brain
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Cancer Site
Hematologic/Blood
|
4 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
|
Cancer Site
Other
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 12 weeksUsing intent-to-treat analysis, 3 (7.7%) PhoneQuit, 2 (5.4%) SmartQuit, and 2 (14.3%) GroupQuit patients reported 7-day point prevalence abstinence from smoking. Smart Quit abstinence was verified with CO readings.
Outcome measures
| Measure |
Cognitive Behavior Therapy With NRT
n=37 Participants
Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.
Nicotine Replacement Therapy: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform.
|
Referral to Area Health Education Center
n=14 Participants
The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
Referral to Qutiline
n=39 Participants
Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use.
The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
|---|---|---|---|
|
Smoking 7-Day Point Prevalence at 12 Weeks
|
2 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Smokers visiting the clinic during the study period
Number of smokers visiting the clinics who are enrolled divided by the total number of smokers visiting the clinics.
Outcome measures
| Measure |
Cognitive Behavior Therapy With NRT
n=545 Participants
Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.
Nicotine Replacement Therapy: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform.
|
Referral to Area Health Education Center
The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
Referral to Qutiline
Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use.
The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
|---|---|---|---|
|
Reach
|
90 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants that completed follow up.
Percent of enrolled patient who completed any tobacco-use treatment.
Outcome measures
| Measure |
Cognitive Behavior Therapy With NRT
n=12 Participants
Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.
Nicotine Replacement Therapy: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform.
|
Referral to Area Health Education Center
n=5 Participants
The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
Referral to Qutiline
n=18 Participants
Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use.
The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
|---|---|---|---|
|
Treatment Utilization
|
7 Participants
|
3 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Participants who completed tobacco-use treatment
Treatment Acceptability (TAQ) consisted of 16 items scored on a 0 to 10 scale (0=worst, 10=best). The questions assessed aspects of treatment acceptability, such as helpfulness in reducing smoking and thoughts and feelings related to the treatment. Data represents the mean score across all items (range 0-10).
Outcome measures
| Measure |
Cognitive Behavior Therapy With NRT
n=4 Participants
Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.
Nicotine Replacement Therapy: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform.
|
Referral to Area Health Education Center
n=2 Participants
The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
Referral to Qutiline
n=11 Participants
Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use.
The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
|---|---|---|---|
|
Mean Treatment Acceptability Score
|
8.1 score on a scale
Standard Deviation 1.2
|
5.7 score on a scale
Standard Deviation 3.5
|
5.9 score on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: Baseline to 12 weeksPopulation: Participants completing 12 week follow up.
Change in Mean Cigarettes Smoked Per Day
Outcome measures
| Measure |
Cognitive Behavior Therapy With NRT
n=12 Participants
Cognitive Behavior Therapy (CBT) will be provided by a certified tobacco treatment specialist (CTTS) using vidyo, a HIPAA-compliant video based platform. Participants in this arm, if interested will be provided a 2 week supply of nicotine replacement therapy (NRT). The intervention in this arm would be NRT along with the CBT counseling.
Nicotine Replacement Therapy: Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform.
|
Referral to Area Health Education Center
n=5 Participants
The Area Health Education Center (AHEC) is a locally available tobacco cessation program aimed at strengthening the capacity of Florida's healthcare system to deliver effective evidence based tobacco use treatment, and prevention services throughout the state. The intervention is education on the health effects related to tobacco use, and benefits of quitting and what to expect when quitting. A tobacco cessation specialist of trained facilitator guides participants as they identify triggers and withdrawal symptoms, and discuss ways to cope with them. The program offers free nicotine replacement therapy, educational materials, goodies for their quit day and follow up support.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
Referral to Qutiline
n=18 Participants
Quitline is a local program in the state where smokers can call a toll free number to talk to coach who can help them quit. There is also an option of online program if they prefer to engage in online help to quit tobacco use.
The intervention in this arm is counseling support by phone or online with an option of Nicotine replacement therapy. If participants prefer this option, our nurse will refer them to locally available quitline service using EPIC.
Referral to AHEC/Quitline: Participants will be referred to local AHEC/Quitline for treatment
|
|---|---|---|---|
|
Change in Cigarettes Smoked Per Day
|
-4.7 cigarettes smoked per day
Standard Deviation 13.7
|
-12.3 cigarettes smoked per day
Standard Deviation 7.5
|
-5.0 cigarettes smoked per day
Standard Deviation 6.3
|
Adverse Events
Cognitive Behavior Therapy With NRT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Referral to Area Health Education Center
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Referral to Qutiline
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ramzi Salloum, Assistant Professor
University of Florida
Phone: 352-294-4997
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place