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

NCT01457469 | Completed Phase 1 FDA Drug

• 3 other identifiers: IRB00014657NCI-2011-02410CCCWFU 99310
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• Abstinence rate in both groups

  3 months

• Comparison of changes in quality of life, stress, and depressive symptoms between groups

  3 months

Study Arms (2)

Arm I (usual care plus) (closed to accrual as of 3/6/2012)

ACTIVE COMPARATOR

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; Procedure: quality-of-life assessment; Other: educational intervention

Arm II (enhanced quitline)

EXPERIMENTAL

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; Procedure: quality-of-life assessment; Other: counseling intervention; Other: internet-based intervention; Behavioral: telephone-based intervention; Drug: nicotine replacement therapy; Other: educational intervention

Interventions

questionnaire administration OTHER

Ancillary studies

Arm I (usual care plus) (closed to accrual as of 3/6/2012); Arm II (enhanced quitline)

quality-of-life assessment PROCEDURE

Ancillary studies

Also known as: quality of life assessment

Arm I (usual care plus) (closed to accrual as of 3/6/2012); Arm II (enhanced quitline)

counseling intervention OTHER

Undergo counseling session

Also known as: counseling and communications studies

Arm II (enhanced quitline)

internet-based intervention OTHER

Receive enhanced quitline intervention

Arm II (enhanced quitline)

telephone-based intervention BEHAVIORAL

Receive enhanced quitline intervention

Arm II (enhanced quitline)

educational intervention OTHER

Receive usual care plus

Also known as: intervention, educational

Arm I (usual care plus) (closed to accrual as of 3/6/2012)

nicotine replacement therapy DRUG

Receive nicotine replacement patches

Also known as: Nicotine Replacement, NRT

Arm II (enhanced quitline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung; Tobacco Use Disorder

Interventions

Counseling; Early Intervention, Educational; Methods; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services; Investigative Techniques; Drug Therapy; Therapeutics

Study Officials

• Kathryn Weaver

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 24, 2011
• Study Start: January 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 1, 2018

Record last verified: 2018-07

Locations

US (1)