Clinical trial · Interventional
Enhanced Quitline Intervention in Smoking Cessation for Patients With Non-Metastatic Lung Cancer
Adapting Smoking Cessation Interventions for the Outpatient Oncology Setting
NCT01457469CI-TRIAL-00034077completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 randomized clinical trial studies enhanced quitline intervention in smoking cessation for patients with non-metastatic lung cancer. Stop-smoking plans suggested by doctors may help patients with early-stage cancer quit smoking
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Limited Stage Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Recurrent Small Cell Lung Cancer | Lung Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IA Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIA Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIA Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| counseling intervention | Other | — | UNRESOLVED |
| educational intervention | Other | — | UNRESOLVED |
| internet-based intervention | Other | — | UNRESOLVED |
| nicotine replacement therapy | Drug | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
| telephone-based intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (usual care plus) (closed to accrual as of 3/6/2012)
- description
- Patients receive a personalized letter from their physician with advice to quit smoking and a copy of the National Cancer Institute's "Cleaning the Air" smoking cessation booklet.
- interventionNames
- Other: questionnaire administration
- Procedure: quality-of-life assessment
- Other: educational intervention
- type
- EXPERIMENTAL
- label
- Arm II (enhanced quitline)
- description
- Patients receive a personalized letter and a smoking cessation booklet. Patients also receive an 8-week supply of nicotine replacement patches and undergo a counseling session over 30-45 minutes with a trained nurse or midlevel provider that focuses on the benefits of quitting smoking for cancer patients and addresses cancer-specific concerns about smoking cessation. Patients also undergo a quitline-based smoking cessation intervention comprising 5 individual 25- to 30-minute telephone counseling sessions and unlimited inbound phone-based access to Quit Coaches over 8-11 weeks, mailed written materials, and an interactive online program.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Diagnosed with American Joint Committee on Cancer (AJCC) stage I-IIIa/b non-small cell lung cancer or limited stage small cell lung cancer Smoked any cigarettes in the past seven days Willing to consider quitting smoking Exclusion Criteria: Patients with drug and alcohol abuse: * All patients will be assessed for alcohol use using a validated 1-item screening question; if positive, patients will be assessed using the validated Alcohol Use Disorders Identification Test (AUDIT) screening instrument, those with scores \>= 8 (the validated cutoff) will be excluded * All patients will be assessed for drug use using a 1-item screening question: "How many times in the past month have you used an illegal drug or used a prescription medication for non-medical reasons?"; those with a response of \>= 1 will be excluded Patient is unable to comprehend study documents and provide informed consent or Eastern Cooperative Oncology Group (ECOG) performance status is greater than two Patient does not read or understand English Patient refuses to participate Patient is contraindicated to receive nicotine replacement therapy: a) Patient is pregnant or breastfeeding, b) Patient has unstable cardiac disease within the past month (defined as unstable angina, myocardial infarction, serious arrhythmias, or any cardiac intervention procedure), or c) Patient is currently taking Chantix Patient does not have regular access to a phone to receive calls from the quitline
References
Publications (0)
Data not yet available
No reference posted for this study.