Novel Treatment to Enhance Smoking Cessation Before Cancer Surgery

Smoking Cessation Clinical Trial

Official title:

Novel Treatment to Enhance Smoking Cessation Before Cancer Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02402023
• Other study ID #: 1407014258
• Secondary ID: R21CA181569
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: September 2017

Study information

• Verified date: March 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Contingency Management (CM)
CM is standard care plus monetary payment delivered contingent on abstinence.
• Standard of Care (SC)
Standard of care consists of smoking cessation counseling sessions and nicotine patches.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Yale Cancer Center	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Continuous Smoking Abstinence	This exploratory aim is to assess the continuous days of abstinence 3 months post surgical procedure. It will be calculated from the Timeline Follow Back (TLFB) and will be defined as the number of days from the first date of self-reported abstinence until the first lapse. These data will be collected from intake through the 3-month follow-up. An independent-samples t-test will be used to compare the days of continuous abstinence for those in the CM group versus the SC group.	3 months
Other	Perioperative Complications	Wound infections will be assessed (purulent discharge, redness, or serous discharge, including a positive microbial culture or treatment with an antibiotic) 3 months post surgical procedure. This will be recorded from the medical provider interview, along with the duration of the event. The initial dependent measure for this analysis will be the percentage of subjects rated as having wound infections. Instances of respiratory complications (severe coughing, laryngospasm, bronchospasm, recurrent apnea, or pneumonia) will be recorded, along with the duration of the event. The initial dependent measure for this analysis will be the percentage of subjects rated as having respiratory complications. Rates of perioperative complications will be analyzed using a chi-square test comparing CM to SC. Through exploratory step-wise regression modeling of the data, we will attempt to ascertain which variables are important and independent factors with regard to surgical outcomes.	3 months
Primary	Pre Surgery Smoking Abstinence	Participants will be classified as succeeded or failed in cessation based on a definition of 1 week of abstinence from cigarettes leading up to the day of their surgery based on self-report and confirmed with biochemical verification (CO=6ppm). For participants who are classified as abstinent, a chi-square will be computed comparing whether treatment with CM is superior to SC in producing a higher probability of abstinence. These data will be used to compute an effect size, Cohen's w, for smoking cessation.	Day of Surgery
Secondary	Post Surgery Smoking Abstinence	Participants will be classified 3 months post surgical procedure as succeeded or failed in cessation based on self-report and confirmed with biochemical verification (CO=6ppm) in the 7 days prior to the 3-month follow-up. For participants who are classified as abstinent, a chi-square will be computed comparing whether treatment with CM is superior to SC in producing a higher probability of abstinence.	3 months