Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
52 participants
INTERVENTIONAL
2024-03-01
2025-08-04
Brief Summary
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Detailed Description
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1\. To generate estimates of the size of the comparative effects of enhanced, cancer-specific smoking cessation treatment versus a generic standard care package similar to quitline care in terms of biochemically confirmed 7-day point prevalence abstinence (no smoking in the past 7 days) 26 weeks after a target quit date.
Exploratory Aims
1. To estimate differences in CET arms in exploratory outcomes including patient acceptability, completion, adherence, costs, and cost-effectiveness.
2. To estimate the extent to which treatment effects on abstinence and exploratory outcomes differ across patient subpopulations based on demographics (age, race, sex, ethnicity, socioeconomic disadvantage); nicotine dependence; and cancer site, stage, and treatment phase.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low-Intensity Standard Smoking Cessation Treatment
2 weeks of nicotine patch therapy, 3 telephone counseling sessions, and information about quitline and National Cancer Institute text messaging support services (SmokefreeTXT)
Transdermal Nicotine Patch
a stop smoking aid, 21 milligrams(mg), 14mg, or 7mg of nicotine delivered over 24 hours
Standard Telephone Counseling
3 brief telephone-based smoking cessation counseling sessions
Mailed Information about Standard Care Resources
Publicly funded treatment resources including the SmokefreeTXT program sponsored by the National Cancer Institute and the Wisconsin Tobacco Quit Line.
High-Intensity, Cancer-Targeted Smoking Cessation Treatment
12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services
Varenicline
12 weeks of an oral smoking cessation medication
Cancer-Targeted Telephone Counseling
7 telephone-based smoking cessation counseling sessions adapted for cancer patients
Mailed Information about Standard Care Resources
Publicly funded treatment resources including the SmokefreeTXT program sponsored by the National Cancer Institute and the Wisconsin Tobacco Quit Line.
Interventions
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Transdermal Nicotine Patch
a stop smoking aid, 21 milligrams(mg), 14mg, or 7mg of nicotine delivered over 24 hours
Standard Telephone Counseling
3 brief telephone-based smoking cessation counseling sessions
Varenicline
12 weeks of an oral smoking cessation medication
Cancer-Targeted Telephone Counseling
7 telephone-based smoking cessation counseling sessions adapted for cancer patients
Mailed Information about Standard Care Resources
Publicly funded treatment resources including the SmokefreeTXT program sponsored by the National Cancer Institute and the Wisconsin Tobacco Quit Line.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosed with cancer in the past 3 years
* Received care from a participating oncology clinic in the past year
* Has a current tobacco use status
* Does not have a preferred language other than English (missing language preference will be included).
* Valid address that is not a correctional facility or residential treatment/care facility.
* No flag for patient cognitive impairment, activated health care power of attorney, or other health care agent (e.g., legally authorized representative) in the EHR.
* Smoked combustible cigarettes in the past month.
* Able to speak and understand English.
* Willing to set a date to quit smoking in the next 60 days.
* Willing to receive smoking treatment information.
* Willing to complete study activities.
Exclusion Criteria
* Suicide attempt in the past year.
* Currently receiving treatment for bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder.
* Incarceration.
* Unable to provide informed consent to treatment (i.e., cannot answer questions about study procedures or risks after hearing about the study).
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Danielle E McCarthy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Wisconsin, Madison
Locations
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UW Carbone Cancer Center
Madison, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Related Links
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UW Center for Tobacco Research and Intervention
Other Identifiers
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Protocol Version 2/13/2024
Identifier Type: OTHER
Identifier Source: secondary_id
SMPH/MEDICINE/GEN INT MD
Identifier Type: OTHER
Identifier Source: secondary_id
UW23091
Identifier Type: OTHER
Identifier Source: secondary_id
2023-1025
Identifier Type: -
Identifier Source: org_study_id
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