Novel Treatment to Enhance Smoking Cessation Before Cancer Surgery

Yale University

Status: Completed

Conditions: Smoking Cessation

Treatments: Behavioral: Standard of Care (SC); Behavioral: Contingency Management (CM)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02402023

R21CA181569 (U.S. NIH Grant/Contract)

1407014258

Details and patient eligibility

About

The purpose of this clinical trial is to determine the feasibility and efficacy of an intervention designed to increase rates of tobacco abstinence for cancer patients before their cancer surgery.

Full description

The investigators are proposing a developmental interdisciplinary pilot study to determine the feasibility and efficacy of an intervention designed to increase rates of tobacco abstinence for cancer patients before their cancer surgery. This study (a follow up to smaller pilot studies) will serve as a means to further develop a treatment protocol and to generate an accurate effect size for a full scale trial. The present study will constitute a development clinical trial with a primary aim of developing an effect size for smoking cessation at the time of surgery (7-day point prevalence abstinence), and a secondary aim of creating an effect size for long-term abstinence at 3 months post-surgery.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. age 18 or older
2. smoking ≥ 1 cigarettes per day
3. CO > 6 ppm
4. diagnosed with or suspicion of any type of operable thoracic, head and neck, breast, or gynecologic cancer
5. agreement on a 2-5-week pre-surgical tobacco intervention by both patient and surgeon, and 6) residence within reasonable driving distance to New Haven.

Exclusion criteria

1. unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia
2. unstable medical conditions that have not been well controlled (e.g., acute infection requiring hospitalization) for the past 30 days
3. pregnant or breastfeeding women
4. those with limited decision making capacity.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

Standard Care (SC)

Active Comparator group

Description:

Patients in the SC arm will receive 4 counseling sessions and nicotine patches as part of typical cessation measures delivered to patients.

Treatment:

Behavioral: Standard of Care (SC)

Contingency Management (CM)

Experimental group

Description:

Patients in the CM arm will receive monetary payment contingent on smoking abstinence (in addition to SC: 4 counseling sessions and nicotine patches).

Treatment:

Behavioral: Standard of Care (SC)

Behavioral: Contingency Management (CM)