Psychotropic Drugs

All Drugs and Chemicals

Bupropion

Nicotine

Varenicline

Participants randomized to "standard care" (SC) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.

Participants randomized to intensive counseling (IC) 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.

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.

Standard Care (SC)

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.
2. Smoking cessation medication: IC participants will be offered a 4-week supply of FDA-approved smoking cessation medication (varenicline, bupropion or nicotine replacement therapy) of their choice, with the option to renew the medication twice for up to 90 days of free medication. Participants are not required to take smoking cessation medication.

Intensive Counseling (IC)

Elyse R Park, Ph.D., MPH

Jamie S. Ostroff, Ph.D.

There are currently over 11 million cancer survivors in the U.S. and survival rates are increasing. Unfortunately, 10-30% of cancer patients are current smokers at the time of diagnosis, and many of these patients have elevated socioeconomic, medical, and psychosocial vulnerabilities. Documented risks associated with continued smoking following cancer diagnosis include decreased survival time; increased complications from surgery, radiation, and chemotherapy; and increased risk of second primary tumors. U.S. Department of Health \& Human Services Public Health Service evidence-based tobacco treatment guidelines exist but have not been integrated into the cancer setting. This is a tremendous missed opportunity to address a modifiable risk factor. In recognition of this treatment gap, the National Cancer Institute (NCI) sponsored a conference in 2009 to address how to increase the readiness and capacity for delivery of tobacco treatment in Cancer Centers. The American Society of Clinical Oncology (ASCO) recommends identification, advice, and counseling of all smokers by their second oncology visit as a core quality indicator; however, currently only half of patients report being asked about tobacco use.

Specific Aim: To conduct a randomized controlled comparative effectiveness trial of two strategies to promote smoking cessation in suspected or newly diagnosed cancer patients.

Study Design: A multi-site randomized controlled comparative effectiveness trial will enroll 295 current smokers with suspected or newly diagnosed melanoma, lymphoma, thoracic, breast, genitourinary, gastrointestinal, head and neck, or gynecologic cancer. Participants will be randomly assigned to receive Intensive Counseling (IC) or "Standard Care" (SC). Both groups will receive an initial motivational counseling session and 3 weekly follow-up counseling sessions with a tobacco treatment counselor, conducted in-person or by telephone. The IC arm has the option to also receive:

* Smoking Cessation Medication: Up to a 12-week supply of FDA approved smoking cessation medication (Varenicline, bupropion, or combination NRT) at no cost to the participant.
* Extended Counseling: An additional 4 biweekly and 3 monthly proactive counseling sessions with a tobacco treatment counselor (total of 11 counseling contacts).

All participants will complete 1 baseline and 2 follow-up surveys, at 3 and 6 months. Self-reported abstinence will be biochemically confirmed at 3 and 6 months.

Specific Aims

Aim 1: To compare the effectiveness of two tobacco treatments that are integrated into cancer care in producing tobacco abstinence at 6 months.

Aim 2: To explore: a) mechanisms through which treatment promotes abstinence; b) subpopulations in which abstinence is promoted; and c) which aspects of treatment promote abstinence.

Aim 3: To compare the incremental cost effectiveness (cost per quit) of two tobacco treatments.

Exploratory Aim: To identify the percentage and associated characteristics of smokers who 1) enroll in tobacco treatment and 2) adhere to tobacco treatment.

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

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

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

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

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

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

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.

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

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

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

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

National Cancer Institute (NCI)

National Institutes of Health (NIH)

Massachusetts General Hospital

Associate Professor of Psychiatry, Harvard Medical School

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.

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.

Standard Treatment (ST)

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

Intensive Treatment (IT)

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.

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

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Associate Professor

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.

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.

Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 6 Months

Participants randomized to ST will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.

Standard Care (SC): (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.

Participants randomized to 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.

Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 3 Months

Participants randomized to ST will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.

.

Standard Treatment

Participants randomized to intensive counseling IT will receive the same 4 initial behavioral counseling sessions with a tobacco treatment counselor as participants in the ST ar,m.

Intensive Treatment)

Number of Participants With Continuous Tobacco Abstinence

Participants randomized to 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:

.

Number of Participants With Sustained Tobacco Abstinence

Participants randomized to 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:

Number of Participants With Self-reported 7-day Point Prevalence.

Participants randomized to ST will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.

S.

The Number of IT Participants Who Used Smoking Cessation Pharmacotherapy

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.

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial	NCT01871506	Smoking Cessati...	Standard Care (... Intensive Couns...	18 Years -	Massachusetts General Hospital
Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial	NCT01871506	Smoking Cessati...	Standard Care (... Intensive Couns...	18 Years -	Massachusetts General Hospital

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