Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment
TTOP
1 other identifier
interventional
126
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2021
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2020
CompletedFirst Posted
Study publicly available on registry
November 18, 2020
CompletedStudy Start
First participant enrolled
January 12, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2026
CompletedFebruary 2, 2026
January 1, 2026
5 years
November 11, 2020
January 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Proportion of participants that quit smoking.
Proportion of participants that quit smoking at the 8 week assessment
at week 8
Prevalence of cigarette use
Seven day point prevalence of cigarette use will be determined from participant reports and CO testing.
at week 8
Secondary Outcomes (5)
Prevalence of cigarette use
6 months
Preferred treatment
at baseline
Change in Cigarette Use
6 months
Drug Compliance
6 months
Counselling Compliance
6 months
Other Outcomes (3)
Number of patients requiring financial assistance with medication.
6 months
Number of patients with alteration in therapy
6 months
Insurance coverage
6 months
Study Arms (12)
Group 1: Varenicline, Intense Counselling and NRT
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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
EXPERIMENTALPatients 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.
Interventions
Varenicline therapy will be 12-week course. On days 1-3 participants will receive 0.5mg once daily; days 4-7 receive 0.5mg twice daily and day 8 until the end of treatment receive 1mg twice daily.
Patients will begin with a dose of 150 mg every morning for 3 days. Then dosage will increase to 150 mg twice daily (morning and evening), for a total daily dose of 300 mg, for 7 to 12 weeks.
Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.
Participants in this group will not receive per required need nicotine replacement therapy.
Participants in this group will receive per required need nicotine replacement therapy.
Eligibility Criteria
You may qualify if:
- newly diagnosed or recurrent tobacco related malignancy
- smoked at least 1 cigarette within 4 weeks of study enrollment
- pack year history of cigarette smoking
- smoked at least 1 cigarette within 1 month of cancer diagnosis
- life expectancy greater than 1 year
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Med Center Health
Bowling Green, Kentucky, 42101, United States
University Of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536, United States
Owensboro Health Mitchell Memorial Cancer Center
Owensboro, Kentucky, 42303, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph Valentino, MD
University of Kentucky
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 11, 2020
First Posted
November 18, 2020
Study Start
January 12, 2021
Primary Completion
January 2, 2026
Study Completion
January 2, 2026
Last Updated
February 2, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share