Adapting Smoking Cessation Interventions for the Outpatient Oncology Setting
I. To demonstrate the feasibility of delivering an enhanced quitline-based smoking cessation
intervention to lung cancer patients in the outpatient oncology setting.
I. To gather preliminary outcome data for an enhanced quitline-based smoking cessation
intervention adapted to the outpatient oncology setting to support future grant
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
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.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Participation of patients with lunch cancer in the outpatient oncology setting
Participation rate will be calculated as the proportion of the eligible patients who agree to participate.
Comprehensive Cancer Center of Wake Forest University
United States: Institutional Review Board
|Wake Forest University Health Sciences||Winston-Salem, North Carolina 27157|