Clinical trial NCT01457469: Enhanced Quitline Intervention in Smoking Cessation for Patients With Non-Metastatic Lung Cancer
Official title: Adapting Smoking Cessation Interventions for the Outpatient Oncology Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
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
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-10-24
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Participation of patients with lunch cancer in the outpatient oncology setting
timeFrame: 1 year
measure: Accrual of patients with lung cancer in the outpatient oncology setting
timeFrame: Over 1 year
measure: Participant retention
timeFrame: 3 months
measure: Participant acceptance of the enhanced quitline-based smoking cessation intervention
timeFrame: 3 months
measure: Protocol fidelity
timeFrame: 3 months
Secondary outcomes:
measure: Abstinence rate in both groups
timeFrame: 3 months
measure: Comparison of changes in quality of life, stress, and depressive symptoms between groups
timeFrame: 3 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Kathryn Weaver
role: PRINCIPAL_INVESTIGATOR
References: