Optimizing tobacco treatment preferences for cancer patients
Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment
PHASE2 · University of Kentucky · NCT04634071
This study is testing different smoking cessation methods for cancer patients to see which ones work best when patients can choose their preferred treatment options.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 126 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Kentucky (other) |
| Locations | 4 sites (Ashland, Kentucky and 3 other locations) |
| Trial ID | NCT04634071 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to identify effective smoking cessation strategies for patients undergoing treatment for tobacco-related cancers. It focuses on incorporating patient preferences into the treatment plan, allowing participants to choose from various cessation strategies, including pharmacologic agents and counseling options. The study will compare the efficacy of these personalized approaches to smoking cessation against previous randomized treatments in a similar population. By understanding patient preferences, the trial seeks to enhance the effectiveness of smoking cessation efforts in a community cancer treatment setting.
Who should consider this trial
Good fit: Ideal candidates are active smoking oncology patients with a diagnosis of a tobacco-related malignancy who are starting a new course of therapy.
Not a fit: Patients who have recently attempted tobacco cessation therapy or have certain medical exclusions, such as uncontrolled psychiatric conditions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve smoking cessation rates among cancer patients, leading to better treatment outcomes and reduced morbidity.
How similar studies have performed: While there is limited research on incorporating patient preferences in tobacco treatment for cancer patients, previous studies have shown success with smoking cessation interventions in similar populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Ashland, Kentucky and 3 other locations
- Kings Daughters Medical Center - Ashland — Ashland, Kentucky, United States (WITHDRAWN)
- Med Center Health — Bowling Green, Kentucky, United States (RECRUITING)
- University Of Kentucky, Markey Cancer Center — Lexington, Kentucky, United States (RECRUITING)
- Owensboro Health Mitchell Memorial Cancer Center — Owensboro, Kentucky, United States (RECRUITING)
Study contacts
- Principal investigator: Joseph Valentino, MD — University of Kentucky
- Study coordinator: Joseph Valentino, MD
- Email: jvale00@uky.edu
- Phone: 859-257-5097
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Smoking Cessation, Cancer, Treatment-Related, Addiction, Cancer Therapy, Tobacco, nicotine