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

NCT ID: NCT01479998

Last Updated: 2020-03-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-06-30

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.

Conditions

Smoking Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard care and nicotine replacement therapy

standard care is 4 counseling sessions and nicotine replacement therapy

Group Type: ACTIVE_COMPARATOR

standard care

Intervention Type: OTHER

standard care plus nicotine replacement therapy

standard care plus NRT plus contingency management

standard care is 4 counseling sessions and nicotine replacement therapy plus 3 weekly meetings with positive reinforcers

Group Type: EXPERIMENTAL

standard care plus contingency management

Intervention Type: OTHER

standard care is 4 counseling sessions and nicotine replacement therapy plus 3 weekly meetings with positive reinforcers

Interventions

standard care

standard care plus nicotine replacement therapy

Intervention Type: OTHER

standard care plus contingency management

standard care is 4 counseling sessions and nicotine replacement therapy plus 3 weekly meetings with positive reinforcers

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Benjamin Toll, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale-New Haven Hospital

New Haven, Connecticut, United States

Yale Cancer Center

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

P50DA009241

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1104008332

Identifier Type: -

Identifier Source: org_study_id