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

This study has suspended participant recruitment.
(Reevaluating recruitment strategies)
Sponsor:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01479998
First received: November 4, 2011
Last updated: October 29, 2012
Last verified: October 2012
History of Changes
  Purpose

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)


Condition Intervention Phase
Smoking Cessation
 Other: standard care
Other: standard care plus contingency management
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Novel Treatments to Enhance Smoking Cessation Before Cancer Surgery: Effects on Smoking and Surgical Outcomes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:
  • smoking cessation [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 32
Study Start Date: November 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard care and nicotine replacement therapy
standard care is 4 counseling sessions and nicotine replacement therapy
 Other: standard care
standard care plus nicotine replacement therapy
Experimental: standard care plus NRT plus contingency management
standard care is 4 counseling sessions and nicotine replacement therapy plus 3 weekly meetings with positive reinforcers
 Other: standard care plus contingency management
standard care is 4 counseling sessions and nicotine replacement therapy plus 3 weekly 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01479998

Locations
United States, Connecticut
Yale Cancer Center
New Haven, Connecticut, United States, 06615
Yale-New Haven Hospital
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Benjamin Toll, PhD Yale University
  More Information

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01479998     History of Changes
Other Study ID Numbers: 1104008332
Study First Received: November 4, 2011
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
smoking cessation
NRT nicotine replacement therapy
CBT cognitive behavioral therapy
contingency management

Additional relevant MeSH terms:
Smoking
Habits
Nicotine
Nicotine polacrilex
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013