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

Adapting Smoking Cessation Interventions for the Outpatient Oncology Setting

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

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder; Stage IIIA Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Recurrent Small Cell Lung Cancer; Limited Stage 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
• Intervention / Treatment: Other: questionnaire administration; Procedure: quality-of-life assessment; Other: educational intervention; Other: educational intervention; Other: counseling intervention; Other: internet-based intervention; Behavioral: telephone-based intervention; Drug: nicotine replacement therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Arm I (usual care plus) (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.	Other: questionnaire administration; Ancillary studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Other: educational intervention; Receive usual care plus; Other Names: intervention, educational; Other: educational intervention; Receive enhanced quitline intervention; Other Names: intervention, educational
EXPERIMENTAL: Arm II (enhanced quitline); 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.	Other: questionnaire administration; Ancillary studies; Procedure: quality-of-life assessment; Ancillary studies; Other Names: quality of life assessment; Other: educational intervention; Receive usual care plus; Other Names: intervention, educational; Other: educational intervention; Receive enhanced quitline intervention; Other Names: intervention, educational; Other: counseling intervention; Undergo counseling session; Other Names: counseling and communications studies; Other: internet-based intervention; Receive enhanced quitline intervention; Behavioral: telephone-based intervention; Receive enhanced quitline intervention; Drug: nicotine replacement therapy; Receive nicotine replacement patches; Other Names: NRT; Nicotine Replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
Accrual of patients with lung cancer in the outpatient oncology setting	Estimated as the number of patients accrued divided by the number of months of accrual.	Over 1 year
Participant retention	Estimated as the proportion of participating patients who complete questionnaires at the three month follow-up. Participants who discontinue the intervention but complete the outcome assessments will be counted in the numerator for calculating retention. Retention estimates will be calculated overall and by intervention arm. A Fisher exact test will be used to assess the difference in retention between the two arms. Kaplan-Meier methods will be used to estimate the time to drop-out, and a logrank test will be used to assess the difference in these distributions between treatment arms.	3 months
Participant acceptance of the enhanced quitline-based smoking cessation intervention	Evaluated by summarizing the intervention participants' ratings of how much they liked and found the intervention and the interventionists to be helpful and sensitive to their concerns. Exact 95% confidence intervals (CI) will be calculated for these estimates. Open-ended questions regarding these issues will be summarized using qualitative methods.	3 months
Protocol fidelity	Summarized by calculating the proportion of participants in both groups who report that they received advice from their physician to quit smoking, estimating the frequency with which intervention participants completed calls and calculating the mean duration of each call, and calculating the proportion of participants that utilized web-based services (including the frequency of the number of logins and sections visited and mean duration of visit).	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Abstinence rate in both groups	3 months
Comparison of changes in quality of life, stress, and depressive symptoms between groups	3 months

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Kathryn Weaver, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (ACTUAL): January 1, 2012
• Study Completion (ACTUAL): May 1, 2012

Study Registration Dates

• First Submitted: October 21, 2011
• First Submitted That Met QC Criteria: October 21, 2011
• First Posted (ESTIMATE): October 24, 2011

Study Record Updates

• Last Update Posted (ACTUAL): August 1, 2018
• Last Update Submitted That Met QC Criteria: July 30, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Tobacco Use Disorder; Small Cell Lung Carcinoma; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: IRB00014657; NCI-2011-02410 (REGISTRY: CTRP (Clinical Trial Reporting Program)); CCCWFU 99310 (OTHER: Wake Forest University Health Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No