Novel Treatments to Enhance Smoking Cessation Before Cancer Surgery: Effects on Smoking and Surgical Outcomes
Participants will be recruited through the Thoracic Oncology Program and the Head and Neck
Cancers Program. At the time of their initial surgical consultation, surgeons and their
support staff in the Thoracic Oncology Program and Head and Neck Cancers Program will advise
all of their patients about the present smoking cessation study as well as the Smoking
Cessation Service at Smilow Cancer Hospital/Yale-New Haven Hospital and other resources in
the community. Patients who express interest in the study and agree to quit smoking will be
met at Smilow/YNHH for an intake appointment by a research assistant. Informed consent will
be obtained prior to any other procedures, then during the intake session medical and
tobacco use histories and breath carbon monoxide (CO) levels will be obtained from all
participants. Study eligibility will be determined in concert with the surgeon and the
principal investigator. As agreed upon by the surgeons, if participants meet eligibility
criteria, their surgery will be scheduled for approximately 3 weeks after they enter the
study.
Eligible participants will be randomized to either: 1) standard care (i.e., 4 counseling
sessions and NRT) or 2) standard care + contingency management (i.e., 4 counseling sessions
and NRT + 3x/week meetings with positive reinforcers). After this, all subjects will be met
by a study therapist for their first counseling session, which is a preparation to quit
session. The study counseling protocol will be based on practical counseling, which is a
cognitive behavioral evidence based smoking cessation treatment modality (Fiore, JaƩn et al.
2008). All participants will be asked to set a quit date within a week after this session.
Consistent with the standard practice of the Smoking Cessation Service, all patients will
receive pharmacotherapy in conjunction with counseling.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
smoking cessation
up to 3 months
No
Benjamin Toll, PhD
Principal Investigator
Yale University
United States: Institutional Review Board
1104008332
NCT01479998
November 2011
June 2013
Name | Location |
---|---|
Yale Cancer Center | New Haven, Connecticut 06520-8028 |
Yale-New Haven Hospital | New Haven, Connecticut 06504 |