Clinical trial NCT01479998: Novel Treatments to Enhance Smoking Cessation Before Cancer Surgery: Effects on Smoking and Surgical Outcomes
Official title: Novel Treatments to Enhance Smoking Cessation Before Cancer Surgery: Effects on Smoking and Surgical Outcomes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Smoking Cessation
Keywords: smoking cessation
NRT nicotine replacement therapy
CBT cognitive behavioral therapy
contingency management
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2011-11-28
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Eligible participants will be randomized to either: 1) standard care (i.e., 4 counseling sessions and nicotine replacement therapy (NRT)) or 2) standard care + contingency management (i.e., 4 counseling sessions and NRT + 3x/week meetings with positive reinforcers)

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: smoking cessation
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale-New Haven Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale Cancer Center
state: Connecticut
Study officials:
affiliation: Yale University
name: Benjamin Toll, PhD
role: PRINCIPAL_INVESTIGATOR
References: