Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial
|ClinicalTrials.gov Identifier: NCT01871506|
Recruitment Status : Active, not recruiting
First Posted : June 6, 2013
Last Update Posted : August 30, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Smoking Cessation||Behavioral: Standard Care (SC) Behavioral: Intensive Counseling (IC)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||303 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial|
|Actual Study Start Date :||September 2013|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||April 2018|
Experimental: 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.
Behavioral: Standard Care (SC)
Other Name: "Standard of Care" Treatment
Experimental: 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:
Behavioral: 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.
Other Name: Intensive Treatment
- Biochemically verified 7-day point prevalence tobacco abstinence at 6 months [ Time Frame: 6 months ]The primary endpoint is 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
- Biochemically verified 7-day point prevalence tobacco abstinence at 3 months [ Time Frame: 3 months ]7-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
- Continuous tobacco abstinence [ Time Frame: 3 months, 6 months ]Continuous tobacco abstinence (between quit and follow-up) at 3 & 6 months
- Sustained tobacco abstinence [ Time Frame: 6 months ]Biochemically confirmed repeated point prevalence abstinence at 3 & 6 months
- Self-reported 7-day point prevalence tobacco abstinence [ Time Frame: 3 months, 6 months ]Self-reported smoking abstinence of at least 7 days
- Significant reduction in cigarette smoking [ Time Frame: 3 months, 6 months ]Self-reported significant reduction (>50% decrease) in cigarettes per day
- Treatment use and adherence [ Time Frame: Treatment Initiation to 6 month follow-up ]The proportion of participants who use 1)smoking cessation pharmacotherapy (varenicline or combination nicotine replacement therapy) 2) smoking cessation counseling, 3)duration (days) of medication use 4)number of counseling contacts, and 5)length of counseling calls.
- Cost-effectiveness [ Time Frame: 6 months ]The incremental cost effectiveness (cost per quit) of the standard of care treatment versus the intensive treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871506
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Elyse R Park, Ph.D., MPH||Massachusetts General Hospital|
|Principal Investigator:||Jamie S. Ostroff, Ph.D.||Memorial Sloan Kettering Cancer Center|