Integrating Tobacco Treatment Into Cancer Care: A Randomized Controlled Comparative Effectiveness Trial
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.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Biochemically verified 7-day point prevalence tobacco abstinence at 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
6 months
No
Elyse R Park, Ph.D., MPH
Principal Investigator
Massachusetts General Hospital
United States: Institutional Review Board
2013P001036
NCT01871506
September 2013
June 2017
Name | Location |
---|---|
Memorial Sloan-Kettering Cancer Center | New York, New York 10021 |
Massachusetts General Hospital | Boston, Massachusetts 02114-2617 |