Clinical trial NCT04634071: Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment
Official title: Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Smoking Cessation
Cancer, Treatment-Related
Keywords: Addiction
Cancer Therapy
Tobacco
nicotine
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2020-11-18
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This trial is a parallel design. However, it is part of a broader sequential cohort design to compare the effects of preference driven tobacco treatment upon cessation versus effects of a previous cohort from a separate randomized controlled trial.
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: Proportion of participants that quit smoking.
timeFrame: at week 8
measure: Prevalence of cigarette use
timeFrame: at week 8
Secondary outcomes:
measure: Prevalence of cigarette use
timeFrame: 6 months
measure: Preferred treatment
timeFrame: at baseline
measure: Change in Cigarette Use
timeFrame: 6 months
measure: Drug Compliance
timeFrame: 6 months
measure: Counselling Compliance
timeFrame: 6 months
Other outcomes:
measure: Number of patients requiring financial assistance with medication.
timeFrame: 6 months
measure: Number of patients with alteration in therapy
timeFrame: 6 months
measure: Insurance coverage
timeFrame: 6 months
Locations:
city: Ashland
country: United States
facility: Kings Daughters Medical Center - Ashland
state: Kentucky
city: Bowling Green
country: United States
facility: Med Center Health
state: Kentucky
city: Lexington
country: United States
facility: University Of Kentucky, Markey Cancer Center
state: Kentucky
city: Owensboro
country: United States
facility: Owensboro Health Mitchell Memorial Cancer Center
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Joseph Valentino, MD
role: PRINCIPAL_INVESTIGATOR
References: