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Completed

NCT Number: NCT02402023

Novel Treatment to Enhance Smoking Cessation Before Cancer Surgery

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale Cancer Center, New Haven, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 18 or older
  • smoking ≥ 1 cigarettes per day
  • CO > 6 ppm
  • diagnosed with or suspicion of any type of operable thoracic, head and neck, breast, or gynecologic cancer
  • 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

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

Treatment and study plan

Contingency management (CM)

Behavioral

CM is standard care plus monetary payment delivered contingent on abstinence.

Standard of Care (SC)

Behavioral

Standard of care consists of smoking cessation counseling sessions and nicotine patches.

Primary outcomes

  1. Pre Surgery Smoking Abstinence

    Time frame: Day of Surgery

    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.

Secondary outcomes

  1. Post Surgery Smoking Abstinence

    Time frame: 3 months

    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.

Other outcomes

  1. Continuous Smoking Abstinence

    Time frame: 3 months

    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.

  2. Perioperative Complications

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Mar 30, 2015
Registry last updated
Mar 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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