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

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.

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