Clinical trial · Interventional
Tobacco Treatment Comparison for Cancer Care
Comparative Effectiveness Trial of Tobacco Cessation Treatments Among Cancer Patients Who Smoke
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Smoking Cessation | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cancer-Targeted Telephone Counseling | Behavioral | — | UNRESOLVED |
| Mailed Information about Standard Care Resources | Other | — | UNRESOLVED |
| Standard Telephone Counseling | Behavioral | — | UNRESOLVED |
| Transdermal Nicotine Patch | Drug | — | UNRESOLVED |
| Varenicline | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Low-Intensity Standard Smoking Cessation Treatment
- description
- 2 weeks of nicotine patch therapy, 3 telephone counseling sessions, and information about quitline and National Cancer Institute text messaging support services (SmokefreeTXT)
- interventionNames
- Drug: Transdermal Nicotine Patch
- Behavioral: Standard Telephone Counseling
- Other: Mailed Information about Standard Care Resources
- type
- EXPERIMENTAL
- label
- High-Intensity, Cancer-Targeted Smoking Cessation Treatment
- description
- 12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services
- interventionNames
- Drug: Varenicline
- Behavioral: Cancer-Targeted Telephone Counseling
- Other: Mailed Information about Standard Care Resources
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available