Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment
- Conditions
- Cancer, Treatment-RelatedSmoking Cessation
- Interventions
- Drug: Long-acting nicotine replacement therapyBehavioral: High-intensity counselingBehavioral: Low-intensity counselingOther: No nicotine replacement therapy
- Registration Number
- NCT04634071
- Lead Sponsor
- Joseph Valentino, MD
- Brief Summary
Smoking cessation has been shown to improve the effectiveness and reduce the morbidity of tobacco-related cancer treatments. We will identify effective smoking cessation strategies for patients who are receiving treatment for tobacco-related cancer. In this trial, patients' preferences in smoking cessation therapy will be the principal determinant by providers in developing a three component regimen of pharmaceutical therapy, counseling, and nicotine replacement therapy. This study will identify this cohort's preferences for smoking cessation strategies. We will then examine the impact of utilizing patient preferences upon cessation efficacy by directly comparing cessation success in this study with our recently completed study of the same population using the same tobacco treatments which were randomly assigned.
- Detailed Description
Background Cigarette smoking is associated with decreased survival and decreased efficacy of cancer therapy in those with smoking related malignancies. There is limited of study of smoking cessation for cancer patients being treated in regions with high tobacco use such as Kentucky. There is little study of cessation implementation in the community cancer treatment setting where the majority of cancer patients receive their cancer therapy. Most smokers have significant exposure to information and personal experience with tobacco treatments which, in some cases, leads to profound preferences. The effect of incorporating these patient preferences into tobacco treatment planning has not been studied or quantified.
Study Design Phase II therapeutic clinical trial.
Setting University of Kentucky Markey Cancer Center (MCC) and its affiliate research network of Community Cancer Centers (MCCRN)
Methods Ninety-three subjects will be selected. All subjects will be active smoking oncology patients with a diagnosis of smoking related malignancy who are beginning a new course of therapy. In conjunction with their treating clinician, all subjects will be counseled and then select one of 12 cessation strategies. This will include a choice of continuous pharmacologic agent (veranicline, bupropion or transdermal nicotine patch), counseling strategy (11 session high intensity motivational based counseling or single session low intensity counseling), and whether or not to use as needed nicotine (gum, lozenges or spray).
Data Analysis All subjects will be followed for six months. The primary endpoint will be a carbon monoxide monitoring confirmed negative seven-day point prevalence report of cessation at eight weeks. Data will then be analyzed and compared with a completed randomized clinical trial of the same treatment strategies in the same population of subjects where the cessation strategy was assigned (historical control). The proportion of subjects that have quit at week eight will be compared to the historical control proportion (namely, whether Ho:p=po vs Ha: p\>po). This will be assessed using a z-score for a binomial proportion which will test whether the underlying proportion quitting at eight weeks (p) differs from the control proportion (po ranging from 0.215 to 0.26) estimated from our recently completed randomized trial of these same 12 cessation strategies.
Revised Enrollment Number: Effective with Amendment 2, Expand targeted enrollment from 96 to 126 due to higher than expected drop-out/censoring rate in order to evaluate the primary endpoint
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 126
- newly diagnosed or recurrent tobacco related malignancy
- smoked at least 1 cigarette within 4 weeks of study enrollment
- 10-pack year history of cigarette smoking
- smoked at least 1 cigarette within 1 month of cancer diagnosis
- life expectancy greater than 1 year
- allergy to buproprion, varenicline and transdermal medicine
- history of suicide attempt
- hospitalized for psychiatric illness within past 2 years
- history of active or uncontrolled eating disorder
- uncontrolled epilepsy or seizure disorder
- pregnant or lactating
- within 3 months of myocardial infarction
- unstable angina
- uncontrolled hypertension
- serious arrhythmia
- history of taking varenicline or buproprion within one month of enrollment
- concurrent enrollment in tobacco cessation therapy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 8: Buproprion, Minimal Counselling Bupropion Patients diagnosed with tobacco-related treatment will receive Buproprion and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 8: Buproprion, Minimal Counselling No nicotine replacement therapy Patients diagnosed with tobacco-related treatment will receive Buproprion and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 9: Nicotine, Intense Counselling and NRT Long-acting nicotine replacement therapy Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch), counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 9: Nicotine, Intense Counselling and NRT High-intensity counseling Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch), counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 10: Nicotine, Intense Counselling Long-acting nicotine replacement therapy Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch) and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 10: Nicotine, Intense Counselling High-intensity counseling Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch) and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 10: Nicotine, Intense Counselling No nicotine replacement therapy Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch) and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 11: Nicotine, Minimal Counselling and NRT Long-acting nicotine replacement therapy Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch), counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 11: Nicotine, Minimal Counselling and NRT Low-intensity counseling Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch), counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 11: Nicotine, Minimal Counselling and NRT Nicotine Replacement Products Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch), counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 12: Nicotine, Minimal Counselling Long-acting nicotine replacement therapy Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch) and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 12: Nicotine, Minimal Counselling Low-intensity counseling Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch) and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 12: Nicotine, Minimal Counselling No nicotine replacement therapy Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch) and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 1: Varenicline, Intense Counselling and NRT High-intensity counseling Patients diagnosed with tobacco-related treatment will receive varenicline, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 1: Varenicline, Intense Counselling and NRT Nicotine Replacement Products Patients diagnosed with tobacco-related treatment will receive varenicline, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group : Varenicline, Intense Counselling High-intensity counseling Patients diagnosed with tobacco-related treatment will receive varenicline and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group : Varenicline, Intense Counselling No nicotine replacement therapy Patients diagnosed with tobacco-related treatment will receive varenicline and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 3: Varenicline, Minimal Counselling and NRT Low-intensity counseling Patients diagnosed with tobacco-related treatment will receive varenicline, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 3: Varenicline, Minimal Counselling and NRT Nicotine Replacement Products Patients diagnosed with tobacco-related treatment will receive varenicline, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 4: Varenicline, Minimal Counselling Low-intensity counseling Patients diagnosed with tobacco-related treatment will receive varenicline and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 4: Varenicline, Minimal Counselling No nicotine replacement therapy Patients diagnosed with tobacco-related treatment will receive varenicline and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 5: Buproprion, Intense Counselling and NRT Bupropion Patients diagnosed with tobacco-related treatment will receive Buproprion, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 5: Buproprion, Intense Counselling and NRT High-intensity counseling Patients diagnosed with tobacco-related treatment will receive Buproprion, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 5: Buproprion, Intense Counselling and NRT Nicotine Replacement Products Patients diagnosed with tobacco-related treatment will receive Buproprion, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 6: Buproprion, Intense Counselling Bupropion Patients diagnosed with tobacco-related treatment will receive Buproprion and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 6: Buproprion, Intense Counselling High-intensity counseling Patients diagnosed with tobacco-related treatment will receive Buproprion and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 6: Buproprion, Intense Counselling No nicotine replacement therapy Patients diagnosed with tobacco-related treatment will receive Buproprion and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 7: Buproprion, Minimal Counselling and NRT Low-intensity counseling Patients diagnosed with tobacco-related treatment will receive Buproprion, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 8: Buproprion, Minimal Counselling Low-intensity counseling Patients diagnosed with tobacco-related treatment will receive Buproprion and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 9: Nicotine, Intense Counselling and NRT Nicotine Replacement Products Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch), counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 7: Buproprion, Minimal Counselling and NRT Nicotine Replacement Products Patients diagnosed with tobacco-related treatment will receive Buproprion, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 1: Varenicline, Intense Counselling and NRT Varenicline Patients diagnosed with tobacco-related treatment will receive varenicline, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group : Varenicline, Intense Counselling Varenicline Patients diagnosed with tobacco-related treatment will receive varenicline and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 3: Varenicline, Minimal Counselling and NRT Varenicline Patients diagnosed with tobacco-related treatment will receive varenicline, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 4: Varenicline, Minimal Counselling Varenicline Patients diagnosed with tobacco-related treatment will receive varenicline and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors. Group 7: Buproprion, Minimal Counselling and NRT Bupropion Patients diagnosed with tobacco-related treatment will receive Buproprion, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.
- Primary Outcome Measures
Name Time Method Proportion of participants that quit smoking. at week 8 Proportion of participants that quit smoking at the 8 week assessment
Prevalence of cigarette use at week 8 Seven day point prevalence of cigarette use will be determined from participant reports and CO testing.
- Secondary Outcome Measures
Name Time Method Prevalence of cigarette use 6 months Seven day point prevalence of cigarette use will be determined from participant reports and CO testing.
Preferred treatment at baseline Proportion of participants preferring the treatment plan.
Change in Cigarette Use 6 months Cigarette use will be recorded at weeks one, four, eight and at 6 months.
Drug Compliance 6 months Subjects who complete 75% of the planned dosages of therapy will be considered compliant.
Counselling Compliance 6 months Subjects who complete 60% of planned therapy sessions will be considered compliant.
Trial Locations
- Locations (4)
Kings Daughters Medical Center - Ashland
🇺🇸Ashland, Kentucky, United States
Med Center Health
🇺🇸Bowling Green, Kentucky, United States
University Of Kentucky, Markey Cancer Center
🇺🇸Lexington, Kentucky, United States
Owensboro Health Mitchell Memorial Cancer Center
🇺🇸Owensboro, Kentucky, United States