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

Not Applicable

Completed

Conditions: Smoking Cessation

Interventions: Behavioral: Standard Care (SC)
Behavioral: Intensive Counseling (IC)

Registration Number: NCT01871506

Lead Sponsor: Massachusetts General Hospital

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 303

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Care (SC)	Standard Care (SC)	Participants randomized to "standard care" (SC) will have the option to receive 4 behavioral counseling sessions with a tobacco treatment counselor and medication advice.
Intensive Counseling (IC)	Intensive Counseling (IC)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The Number of IT Participants Who Used Smoking Cessation Pharmacotherapy	Treatment Initiation to 6 month follow-up	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 IT Participants Who Took 1-3 Monthly Booster Sessions	Treatment Initiation to 6 Month Follow-up	The number of IT participants who took 1-3 monthly booster sessions of smoking cessation counseling
Number of Participants With Sustained Tobacco Abstinence	6 months	Number of Participants with Biochemically confirmed repeated point prevalence abstinence at 3 \& 6 months
The Number of IT Participants Who Took 1-2 4-week Refills	Treatment Initiation to 6 Month Follow-up	The number of intervention participants who took 1-2 4-week refills of smoking cessation medication
Number of Participants With Continuous Tobacco Abstinence	3 months to 6 months	Number of Participants with Continuous tobacco abstinence (between quit and follow-up) at 3 \& 6 months
Number of Participants With Self-reported 7-day Point Prevalence.	6 months	Number of Participants with Self-reported smoking abstinence of at least 7 days
Number of Participants With Biochemically Verified 7-day Point Prevalence Tobacco Abstinence at 3 Months	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
The Number of IT Participants Who Used Smoking Cessation Counseling	Treatment Initiation to 6 Month Follow-up	The number of intervention participants who used smoking cessation counseling during the study (Y/N)
Cost-effectiveness	6 months	The cost of the standard of care treatment and the cost of the intensive treatment.

Trial Locations

Locations (3): Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
🇺🇸
Boston, Massachusetts, United States
Memorial Sloan-Kettering Cancer Center
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New York, New York, United States