Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes

Phase 3

Terminated

Conditions: Lung Carcinoma

Interventions: Drug: Placebo
Drug: Varenicline
Other: Tobacco Cessation Counseling

Registration Number: NCT02856581

Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (placebo and behavioral intervention)	Placebo	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.
Control group (placebo and behavioral intervention)	Tobacco Cessation Counseling	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.
Intervention group (varenicline and behavioral intervention)	Tobacco Cessation Counseling	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.
Intervention group (varenicline and behavioral intervention)	Varenicline	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.

Primary Outcome Measures

Name	Time	Method
Mortality	Up to 30 days post-surgery	Number of patients that died within 30 days of surgery
Number of Paticipants With Incidence of Pulmonary Complications	Up to 24 weeks post-surgery	Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, Fagerström Test for Nicotine Dependence (FTND), time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Number of Participants With Incidence of Anastomotic Failure	Up to 24 weeks post-surgery	Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Number of Participants With Incidence of Unspecified Wound Infection	Up to 24 weeks post-surgery	Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.
Re-hospitalization	Up to 30 days post-surgery	Number of patients re-hospitalized within 30 days of surgery
Number of Participants With Incidence of Intensive Care Unit Readmission	Up to 24 weeks post-surgery	Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.

Secondary Outcome Measures

Name	Time	Method
Change in QOL as Measured by the LASA-12, PHQ-9, SEQ-12	Baseline up to 24 weeks after surgery	Analysis of covariance and linear mixed model repeated measures analysis will be used for each assessment domain (LASA-12, PHQ-9, SEQ12).
Expanded Complication Rate	Up to 1 year
Treatment Adherence Rates Related to Visits, Medication Compliance, Quitline Usage, and Surgeon Teachable Moment Delivery	Up to 12 weeks
Length of Hospital Stay	The time from surgery until the patient is released from the hospital	Logrank testing of Kaplan-Meier estimates will be used for length of hospital stay and supplemented by Cox models to control for concomitant covariates.
Change in QOL as Measured by Was It Worth It Assessments	At 24 weeks after surgery
Length of High Dependency Unit Stay	The time from surgery until the patient is released from the hospital	Logrank testing of Kaplan-Meier estimates will be used for length of high dependency unit stay and supplemented by Cox models to control for concomitant covariates.
Smoking Abstinence Rates as Measured by Self-report	Up to 12 weeks
Smoking Abstinence Rates as Measured by Salivary Cotinine Testing	Up to 12 weeks

Trial Locations

Locations (374): Fairbanks Memorial Hospital
🇺🇸
Fairbanks, Alaska, United States
Kingman Regional Medical Center
🇺🇸
Kingman, Arizona, United States
Baptist Memorial Hospital and Fowler Family Cancer Center - Jonesboro
🇺🇸
Jonesboro, Arkansas, United States
PCR Oncology
🇺🇸
Arroyo Grande, California, United States
Veterans Affairs Loma Linda Healthcare System
🇺🇸
Loma Linda, California, United States
Eisenhower Medical Center
🇺🇸
Rancho Mirage, California, United States
Saint Helena Hospital
🇺🇸
Saint Helena, California, United States
Rocky Mountain Cancer Centers-Aurora
🇺🇸
Aurora, Colorado, United States
The Medical Center of Aurora
🇺🇸
Aurora, Colorado, United States
University of Colorado Hospital
🇺🇸
Aurora, Colorado, United States
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Fairbanks Memorial Hospital
🇺🇸Fairbanks, Alaska, United States