NCT01457469

Enhanced Quitline Intervention in Smoking Cessation for Patients With Non-Metastatic Lung Cancer

Adapting Smoking Cessation Interventions for the Outpatient Oncology Setting

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

PRIMARY OBJECTIVES: I. To demonstrate the feasibility of delivering an enhanced quitline-based smoking cessation intervention to lung cancer patients in the outpatient oncology setting. SECONDARY OBJECTIVES: I. To gather preliminary outcome data for an enhanced quitline-based smoking cessation intervention adapted to the outpatient oncology setting to support future grant applications. II. To evaluate change in primary patient reported outcomes, including quality of life (quantified by the Functional Assessment of Cancer Therapy - Lung \[FACT-L\] and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer Module \[EORTC QLQ LC13\]), perceived life stress (quantified by the Perceived Stress Scale), and depression (quantified by the Center for Epidemiological Studies Short Depression Scale \[CESD-10\]), in lung cancer patients in the intervention and control conditions (control arm closed to accrual as of 3/6/2012) from baseline to 3-months following randomization. OUTLINE: Patients are randomized to 1 of 2 treatment arms. ARM I (closed to accrual as of 3/6/2012): 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. ARM II: 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. After completion of study treatment, patients are followed up at 3 months.

Conditions

• Limited Stage Small Cell Lung Cancer
• Recurrent Small Cell Lung Cancer
• Stage IA Non-small Cell Lung Cancer
• Stage IB Non-small Cell Lung Cancer
• Stage IIA Non-small Cell Lung Cancer
• Stage IIB Non-small Cell Lung Cancer
• Stage IIIA Non-small Cell Lung Cancer
• Stage IIIB Non-small Cell Lung Cancer
• Tobacco Use Disorder

Interventions

Type	Name	Description
OTHER	questionnaire administration	Ancillary studies
PROCEDURE	quality-of-life assessment	Ancillary studies
OTHER	counseling intervention	Undergo counseling session
OTHER	internet-based intervention	Receive enhanced quitline intervention
BEHAVIORAL	telephone-based intervention	Receive enhanced quitline intervention
OTHER	educational intervention	Receive usual care plus
DRUG	nicotine replacement therapy	Receive nicotine replacement patches
OTHER	educational intervention	Receive enhanced quitline intervention

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-01-01
• Completion: 2012-05-01
• First posted: 2011-10-24
• Last updated: 2018-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study