Skip to main content
Clinical Trials/NCT01479998
NCT01479998
Terminated
Phase 1

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

Yale University2 sites in 1 country8 target enrollmentNovember 2011

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Smoking Cessation
Sponsor
Yale University
Enrollment
8
Locations
2
Primary Endpoint
smoking cessation
Status
Terminated
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
June 2013
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 18 or older,
  • smoking 5 or more cigarettes per day, and
  • diagnosed with any type of head, neck, or thoracic cancer,
  • agreement on a 3-week pre-surgical tobacco intervention by both patient and surgeon.

Exclusion Criteria

  • Unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia,
  • history of allergic reactions to adhesives,
  • females of childbearing potential who are pregnant, nursing, or not practicing effective contraception.

Outcomes

Primary Outcomes

smoking cessation

Time Frame: up to 3 months

Study Sites (2)

Loading locations...

Similar Trials