Trial Outcomes & Findings for Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial (NCT NCT01871506)

Last Updated: 2019-08-28

Results Overview

Number of participants with 7-day point-prevalence tobacco abstinence at 6-month follow-up, assessed by biochemically confirmed saliva cotinine (\<15 ng/ml76, 82) or \<10 ppm expired air carbon monoxide (CO) for participants concurrently using NRT

Recruitment status

COMPLETED

Study phase

Target enrollment

303 participants

Primary outcome timeframe

6 months

Results posted on

2019-08-28

Participant Flow

Between 11/25/2013 and 7/1/2017 4709 patients were screened for eligibility. 2659 were eligible based on screen criteria; 1808 did not complete the screen. Of the 851 who were approached to complete the screen, 405 were ineligible, 303 enrolled and were randomized, and 143 refused (84 refused consent and 59 did not complete the baseline survey)

Of the 446 eligible for the study, 303 were randomized, 84 were eligible but refused consent (top 3 reasons: too upset, did not need help, had no time) and 59 were eligible but were not randomized because they did not complete a baseline survey.

Participant milestones

Participant milestones
Measure	Standard Treatment (ST) Participants randomized to "standard treatment" will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) Participants randomized to intensive treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the ST arm. IT participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. Intensive Treatment (IT): The IT model includes all components of the ST as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication.
Overall Study STARTED	150	153
Overall Study COMPLETED	150	153
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Treatment (ST) n=150 Participants Participants randomized to "standard treatment" will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: ST Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) n=153 Participants Participants randomized to intensive treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IC participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. Intensive Counseling: The IT model includes all components of the ST as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication.	Total n=303 Participants Total of all reporting groups
Age, Continuous	58 years STANDARD_DEVIATION 9.5 • n=93 Participants	58 years STANDARD_DEVIATION 9.9 • n=4 Participants	58 years STANDARD_DEVIATION 9.7 • n=27 Participants
Sex: Female, Male Female	83 Participants n=93 Participants	87 Participants n=4 Participants	170 Participants n=27 Participants
Sex: Female, Male Male	67 Participants n=93 Participants	66 Participants n=4 Participants	133 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	7 Participants n=4 Participants	11 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	146 Participants n=93 Participants	146 Participants n=4 Participants	292 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	2 Participants n=4 Participants	3 Participants n=27 Participants
Race (NIH/OMB) Asian	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	17 Participants n=93 Participants	14 Participants n=4 Participants	31 Participants n=27 Participants
Race (NIH/OMB) White	131 Participants n=93 Participants	134 Participants n=4 Participants	265 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	2 Participants n=4 Participants	2 Participants n=27 Participants
Region of Enrollment United States	150 participants n=93 Participants	153 participants n=4 Participants	303 participants n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Population: Twenty participants were too ill or deceased to complete follow-up assessment. Given the study participant population of cancer patients, our trial was powered accounting for cancer deaths and reporting participants who were alive at follow-up assessment.

Outcome measures

Outcome measures
Measure	Standard Treatment (ST) n=135 Participants Participants randomized to "standard treatment" (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) n=148 Participants Participants randomized to the Intensive Treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. Intensive Counseling (IC): The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. (1) Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 6 Months	29 Participants	51 Participants

SECONDARY outcome

Timeframe: 3 months

Number of participants with7 -day point-prevalence tobacco abstinence at 3-month follow-up, assessed by biochemically confirmed saliva cotinine (\<15 ng/ml76, 82) or \<10 ppm expired air carbon monoxide (CO) for participants concurrently using NRT

Outcome measures

Outcome measures
Measure	Standard Treatment (ST) n=135 Participants Participants randomized to "standard treatment" (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) n=148 Participants Participants randomized to the Intensive Treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. Intensive Counseling (IC): The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. (1) Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 3 Months	28 Participants	46 Participants

SECONDARY outcome

Timeframe: 3 months to 6 months

Number of Participants with Continuous tobacco abstinence (between quit and follow-up) at 3 \& 6 months

Outcome measures

Outcome measures
Measure	Standard Treatment (ST) n=135 Participants Participants randomized to "standard treatment" (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) n=148 Participants Participants randomized to the Intensive Treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. Intensive Counseling (IC): The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. (1) Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
Number of Participants With Continuous Tobacco Abstinence	26 Participants	43 Participants

SECONDARY outcome

Timeframe: 6 months

Number of Participants with Biochemically confirmed repeated point prevalence abstinence at 3 \& 6 months

Outcome measures

Outcome measures
Measure	Standard Treatment (ST) n=135 Participants Participants randomized to "standard treatment" (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) n=148 Participants Participants randomized to the Intensive Treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. Intensive Counseling (IC): The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. (1) Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
Number of Participants With Sustained Tobacco Abstinence	17 Participants	35 Participants

SECONDARY outcome

Timeframe: 6 months

Number of Participants with Self-reported smoking abstinence of at least 7 days

Outcome measures

Outcome measures
Measure	Standard Treatment (ST) n=135 Participants Participants randomized to "standard treatment" (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) n=148 Participants Participants randomized to the Intensive Treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. Intensive Counseling (IC): The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. (1) Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
Number of Participants With Self-reported 7-day Point Prevalence.	42 Participants	54 Participants

SECONDARY outcome

Timeframe: Treatment Initiation to 6 month follow-up

Population: Only assessed intensive treatment arm.

The number of IT participants who used 1) smoking cessation pharmacotherapy (Y/N dispensed) 2) smoking cessation counseling (Y/N), 3) 1-2 4-week refills, 4) took 1-3 monthly booster sessions.

Outcome measures

Outcome measures
Measure	Standard Treatment (ST) Participants randomized to "standard treatment" (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) n=153 Participants Participants randomized to the Intensive Treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. Intensive Counseling (IC): The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. (1) Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
The Number of IT Participants Who Used Smoking Cessation Pharmacotherapy	—	122 Participants

SECONDARY outcome

Timeframe: Treatment Initiation to 6 Month Follow-up

Population: Only assessed intensive treatment arm

The number of intervention participants who used smoking cessation counseling during the study (Y/N)

Outcome measures

Outcome measures
Measure	Standard Treatment (ST) Participants randomized to "standard treatment" (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) n=153 Participants Participants randomized to the Intensive Treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. Intensive Counseling (IC): The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. (1) Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
The Number of IT Participants Who Used Smoking Cessation Counseling	—	153 Participants

SECONDARY outcome

Timeframe: Treatment Initiation to 6 Month Follow-up

Population: Only assessed intensive treatment arm

The number of intervention participants who took 1-2 4-week refills of smoking cessation medication

Outcome measures

Outcome measures
Measure	Standard Treatment (ST) Participants randomized to "standard treatment" (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) n=153 Participants Participants randomized to the Intensive Treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. Intensive Counseling (IC): The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. (1) Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
The Number of IT Participants Who Took 1-2 4-week Refills	—	87 Participants

SECONDARY outcome

Timeframe: Treatment Initiation to 6 Month Follow-up

Population: Only assessed intensive treatment arm

The number of IT participants who took 1-3 monthly booster sessions of smoking cessation counseling

Outcome measures

Outcome measures
Measure	Standard Treatment (ST) Participants randomized to "standard treatment" (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) n=153 Participants Participants randomized to the Intensive Treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. Intensive Counseling (IC): The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. (1) Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
The Number of IT Participants Who Took 1-3 Monthly Booster Sessions	—	99 Participants

SECONDARY outcome

Timeframe: 6 months

Population: Cost per quit (in dollars) are shown below.

The cost of the standard of care treatment and the cost of the intensive treatment.

Outcome measures

Outcome measures
Measure	Standard Treatment (ST) n=150 Participants Participants randomized to "standard treatment" (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) n=153 Participants Participants randomized to the Intensive Treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. Intensive Counseling (IC): The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication. (1) Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
Cost-effectiveness	638 dollars Interval 570.0 to 710.0	1144 dollars Interval 1061.0 to 1231.0

Adverse Events

Standard Treatment (ST)

Serious events: 0 serious events

Other events: 17 other events

Deaths: 9 deaths

Intensive Treatment (IT)

Serious events: 0 serious events

Other events: 41 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Associate Professor

Elyse Park

Phone: 617-724-6836

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Standard Treatment (ST) n=150 participants at risk Participants randomized to "standard treatment" (ST) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice. Standard Treatment (ST): (1) Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques. (2) 3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment. (3) Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects.	Intensive Treatment (IT) n=153 participants at risk Participants randomized to intensive treatment (IT) will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the SC arm. IT participants have the option to also receive: * Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts). * Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication \[varenicline, bupropion, or combination NRT (patch + lozenge)\] at no cost to the participant. I
General disorders Nausea	4.0% 6/150 • Number of events 6 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	8.5% 13/153 • Number of events 13 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Rash	0.67% 1/150 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	2.6% 4/153 • Number of events 4 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Hiccups	0.67% 1/150 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	2.0% 3/153 • Number of events 3 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders SIADH	0.00% 0/150 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	1.3% 2/153 • Number of events 2 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Bad taste in mouth	0.00% 0/150 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	0.65% 1/153 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Flatulence	0.67% 1/150 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	0.65% 1/153 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Mouth irritation	0.00% 0/150 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	2.6% 4/153 • Number of events 4 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Difficulty sleeping	1.3% 2/150 • Number of events 2 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	2.0% 3/153 • Number of events 3 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Fatigue	0.00% 0/150 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	0.65% 1/153 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Chest discomfort	0.00% 0/150 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	0.65% 1/153 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Pain in lower back and leg	0.00% 0/150 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	0.65% 1/153 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Headache	1.3% 2/150 • Number of events 2 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	0.65% 1/153 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Heartburn	0.67% 1/150 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	0.00% 0/153 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Lightheadedness	0.00% 0/150 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	0.65% 1/153 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Swollen ankles	0.67% 1/150 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	0.00% 0/153 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Vivid dreams	1.3% 2/150 • Number of events 2 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	2.0% 3/153 • Number of events 3 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Malaise	0.00% 0/150 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	0.65% 1/153 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.
General disorders Shortness of breath	0.00% 0/150 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.	0.65% 1/153 • Number of events 1 • Adverse events for each participant was collected over a 6-month period: from baseline to 6 month follow-up. Adverse events: Any untoward or unfavorable medical occurrence in a human subject including any abnormal sign, symptom, or disease...whether or not associated with the subject's participation in research. \*Adverse events that are expected (i.e., documented in the protocol) are not reported to the IRB. More than one adverse event could be reported per participant.