Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes
Purpose
This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline [tobacco cessation service available through a toll-free telephone number] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.
Condition
- Lung Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Criteria
- Eligible patients will have a new diagnosis of lung cancer and have sought a surgical
consult relating to this diagnosis
- Surgery must be scheduled no sooner than 10 days after randomization and no more than
twelve weeks after randomization
- Have smoked daily or nearly every day in the previous 6 months up to the date of
surgical consult AND have smoked at least one puff in the previous 7 days
- Motivated to stop smoking, as indicated by a score of 6 or above on the Contemplation
Ladder
- Within the 30 days before registration, no use of: 1) any pharmacologic treatment for
smoking cessation, including bupropion or nicotine replacement therapy; 2) any
nicotine delivery system (i.e., e-cigarettes and vape products); or 3) be enrolled in
any formal behavioral treatment program for tobacco dependence as determined by
patient report
- No allergies to and not currently using varenicline
- No suicidal thoughts as indicated by a positive (1+) response to the PHQ9
- No active untreated clinically significant psychiatric condition (psychosis, bipolar
disorder, or depression)
- Negative pregnancy test (serum or urine) done =< 7 days prior to registration, for
women of childbearing potential only
* A female of childbearing potential is a sexually mature female who: 1) has not
undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally
postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in
the preceding 12 consecutive months)
- No unstable angina, myocardial infarction, or coronary angioplasty within the past 3
months or an untreated cardiac dysrhythmia
- No history of seizures
- No unstable neurologic, hepatic, renal, cardiovascular, lymphatic, or metabolic
disease
- Not currently on renal dialysis or has a history of significant renal impairment
- No recent history (=< 90 days) of substance abuse (outside of tobacco) defined by
National Institute on Alcohol Abuse and Alcoholism (NIAAA) as:
- If male, drinking > 14 alcoholic beverages per week for past 1 month
- If female, drinking > 7 alcoholic beverages per week for past 1 month
- Use of cocaine, heroin, club drugs (i.e., 3,4-methylenedioxymethamphetamine
(MDMA)/"ecstasy"), methamphetamine, or hallucinogens (e.g., lysergic acid
diethylamide [LSD]) at any time during the past 1 month
- Use of marijuana on a weekly basis for the past 1 month
- Patients must be able to complete study questionnaires in English
- No other household member or relative participating in the study
- No known history of any condition or factor judged by the investigator to preclude
participation in the study or which might hinder study adherence
- Calculated creatinine clearance >= 30 mL/min * For females, use 85% of calculated
creatinine clearance (CrCl) value
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Intervention group (varenicline and behavioral intervention) |
Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult. |
|
|
Placebo Comparator Control group (placebo and behavioral intervention) |
Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult. |
|
More Details
- Status
- Terminated
- Sponsor
- Alliance for Clinical Trials in Oncology
Study Contact
Detailed Description
PRIMARY OBJECTIVES: I. To determine if varenicline plus a behavioral intervention consisting of a brief clinician-delivered intervention and tobacco quitline follow-up, decreases postsurgical complications through 24 weeks after surgery when compared to placebo plus the behavioral intervention in lung cancer patients who undergo surgery and are motivated to stop smoking. SECONDARY OBJECTIVES: I. To compare changes from baseline to 12 and 24 weeks after surgery in the patient quality of life (Linear Analogue Self-Assessment [LASA]-12) domains between the intervention (varenicline) and control group (placebo). II. To compare changes from baseline to 6, 12 and 24 weeks after surgery in the patient quality of life related domains (LASA) for the Patient Health Questionnaire (PHQ)-9 and Smoking Self Efficacy Questionnaire (SEQ)12 between the intervention and control groups. III. To compare the proportion of patients 12 weeks and 24 weeks after surgery who endorse ("Was It Worth It") each treatment (intervention versus [vs] control groups). IV. To compare post-operative care (as measured by length of hospital and high dependency unit stay) between the intervention and control groups. V. To compare treatment adherence between the intervention and control groups. VI. To compare rates of smoking abstinence between the intervention and control groups as a covariate of the primary outcome only.