Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial
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.
Behavioral: Standard Care (SC)
Behavioral: Intensive Counseling (IC)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial|
- 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 point prevalence tobacco abstinence [ Time Frame: 3 months, 6 months ]
- Significant reduction in cigarette smoking [ Time Frame: 3 months, 6 months ]Self-reported significant reduction (>50% decrease) in cigarettes per day
- 7-day intentional quit attempt [ Time Frame: 3 months, 6 months ]Self-reported 7-day intentional quit attempt
- 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.
- All-cause hospitalizations [ Time Frame: 6 months ]All-cause hospitalizations over the 6 months of patient study involvement will be documented and reviewed. Hospitalizations are expected to be high in this vulnerable population of cancer patients.
- All- cause mortality [ Time Frame: 6 months ]All-cause deaths over the 6 month patient study involvement will be documented and reviewed.
- Cost-effectiveness [ Time Frame: 6 months ]The incremental cost effectiveness (cost per quit) of the standard of care treatment versus the intensive treatment.
|Study Start Date:||September 2013|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||June 2017 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01871506
|Contact: Elyse R. Park, Ph.D., MPHfirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Elyse R. Park, Ph.D., MPH email@example.com|
|Principal Investigator: Elyse R. Park, Ph.D., MPH|
|Dana-Farber Cancer Institute||Not yet recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Mary E Cooley, PhD, RN MECOOLEY@BICS.BWH.HARVARD.EDU|
|Sub-Investigator: Mary E Cooley, PhD, RN|
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Jamie S. Ostroff, Ph.D. ostroffj@MSKCC.ORG|
|Principal Investigator: Jamie S. Ostroff, Ph.D.|
|Principal Investigator:||Elyse R Park, Ph.D., MPH||Massachusetts General Hospital|
|Principal Investigator:||Jamie S. Ostroff, Ph.D.||Memorial Sloan Kettering Cancer Center|