Clinical trial NCT06218823: Tobacco Treatment Comparison for Cancer Care
Official title: Comparative Effectiveness Trial of Tobacco Cessation Treatments Among Cancer Patients Who Smoke
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Smoking Cessation
Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-01-23
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This pilot comparative effectiveness trial will compare two active smoking cessation treatments in terms of effectiveness, equity across patient subpopulations, and efficiency among adult patients diagnosed with cancer within the past 3 years. An enhanced treatment comprising 12 weeks of varenicline treatment and 7 smoking cessation coaching calls with a cancer focus will be compared against an active comparator modeled after standard quitline treatments (2 weeks of nicotine patch therapy with 3 phone coaching calls). Approximately 50 participants will be recruited to generate estimates of the effects, acceptability, costs, and equity of enhanced treatment (vs. standard treatment), with the primary outcome being abstinence from smoking 26 weeks after trying to quit.

Detailed description: Primary Aim

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.

Eligibility criteria: Inclusion Criteria:

* Alive (per medical record)
* 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.

The following additional inclusion criteria must be met for inclusion in the CET

* 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:

* No current suicidal ideation.
* 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).

Primary outcomes:
measure: Biochemically verified 7-day point-prevalence abstinence 26 weeks after a target quit date.
timeFrame: up to 30 weeks post target quit date
Secondary outcomes:
measure: Self-reported 7-day point-prevalence abstinence 12 weeks after a target quit date.
timeFrame: up to 13 weeks post target quit date
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Danielle E McCarthy, PhD
role: PRINCIPAL_INVESTIGATOR
References: