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Adapting Smoking Cessation Interventions for the Outpatient Oncology Setting


Phase 1
18 Years
N/A
Open (Enrolling)
Both
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

Thank you

Trial Information

Adapting Smoking Cessation Interventions for the Outpatient Oncology Setting


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Participation of patients with lunch cancer in the outpatient oncology setting

Outcome Description:

Participation rate will be calculated as the proportion of the eligible patients who agree to participate.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Kathryn Weaver

Investigator Role:

Principal Investigator

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Institutional Review Board

Study ID:

CCCWFU 99310

NCT ID:

NCT01457469

Start Date:

January 2011

Completion Date:

Related Keywords:

  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Tobacco Use Disorder
  • Small Cell Lung Carcinoma

Name

Location
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157