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Novel Treatments to Enhance Smoking Cessation Before Cancer Surgery: Effects on Smoking and Surgical Outcomes


Phase 1
18 Years
85 Years
Not Enrolling
Both
Smoking Cessation

Thank you

Trial Information

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, Jaén 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.


Inclusion Criteria:



1. Age 18 or older,

2. smoking 5 or more cigarettes per day, and

3. diagnosed with any type of head, neck, or thoracic cancer,

4. agreement on a 3-week pre-surgical tobacco intervention by both patient and surgeon.

Exclusion Criteria:

1. Unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis,
severe alcohol dependence, or dementia,

2. history of allergic reactions to adhesives,

3. females of childbearing potential who are pregnant, nursing, or not practicing
effective contraception.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

smoking cessation

Outcome Time Frame:

up to 3 months

Safety Issue:

No

Principal Investigator

Benjamin Toll, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yale University

Authority:

United States: Institutional Review Board

Study ID:

1104008332

NCT ID:

NCT01479998

Start Date:

November 2011

Completion Date:

June 2013

Related Keywords:

  • Smoking Cessation
  • smoking cessation
  • NRT nicotine replacement therapy
  • CBT cognitive behavioral therapy
  • contingency management
  • Smoking

Name

Location
Yale Cancer Center New Haven, Connecticut  06520-8028
Yale-New Haven Hospital New Haven, Connecticut  06504