Clinical trial · Interventional
Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)
Improving the Quality of Smoking Cessation and Shared Decision Making for Lung Cancer Screening: A Cluster Randomized Trial
- 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 trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Smoking | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Best Practice | Other | — | UNRESOLVED |
| Nicotine Patch | Drug | — | UNRESOLVED |
| Quality-of-Life Assessment | Other | — | UNRESOLVED |
| Questionnaire Administration | Other | — | UNRESOLVED |
| Tobacco Cessation Counseling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (centralized care strategy)
- description
- Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.
- interventionNames
- Drug: Nicotine Patch
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
- Other: Tobacco Cessation Counseling
- type
- ACTIVE_COMPARATOR
- label
- Group II (usual care)
- description
- Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.
- interventionNames
- Other: Best Practice
- Other: Quality-of-Life Assessment
- Other: Questionnaire Administration
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 77 Years
Show eligibility criteria text
Inclusion Criteria: * PATIENTS: Primary care patients * PATIENTS: Upcoming primary care office visit * PATIENTS: Current smoker * PATIENTS: 30 plus (+) pack-year smoking history * PATIENTS: English-speaking * PROVIDERS: Primary health care providers * PROVIDERS: Provide care to adults Exclusion Criteria: * PATIENTS: History of lung cancer by self-report
References
Publications (1)
- DERIVEDLowenstein LM, Shih YT, Minnix J, Lopez-Olivo MA, Maki KG, Kypriotakis G, Leal VB, Shete SS, Fox J, Nishi SP, Cinciripini PM, Volk RJ. A protocol for a cluster randomized trial of care delivery models to improve the quality of smoking cessation and shared decision making for lung cancer screening. Contemp Clin Trials. 2023 May;128:107141. doi: 10.1016/j.cct.2023.107141. Epub 2023 Mar 5. PMID 36878389