Enhanced Quitline Intervention in Smoking Cessation for Patients With Non-Metastatic Lung Cancer
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Other: questionnaire administration Procedure: quality-of-life assessment Other: counseling intervention Other: internet-based intervention Behavioral: telephone-based intervention Other: educational intervention Drug: nicotine replacement therapy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Adapting Smoking Cessation Interventions for the Outpatient Oncology Setting |
- Participation of patients with lunch cancer in the outpatient oncology setting [ Time Frame: 1 year ] [ Designated as safety issue: No ]Participation rate will be calculated as the proportion of the eligible patients who agree to participate.
- Accrual of patients with lung cancer in the outpatient oncology setting [ Time Frame: Over 1 year ] [ Designated as safety issue: No ]Estimated as the number of patients accrued divided by the number of months of accrual.
- Participant retention [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Participant acceptance of the enhanced quitline-based smoking cessation intervention [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Protocol fidelity [ Time Frame: 3 months ] [ Designated as safety issue: No ]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).
- Abstinence rate in both groups [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- Comparison of changes in quality of life, stress, and depressive symptoms between groups [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 10 |
| Study Start Date: | January 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: quality of life assessment
Other: educational intervention
Receive usual care plus
Other Name: 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 Name: quality of life assessment
Other: counseling intervention
Undergo counseling session
Other Name: 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:
Other: educational intervention
Receive enhanced quitline intervention
Other Name: intervention, educational
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| United States, North Carolina | |
| Wake Forest University Health Sciences | |
| Winston-Salem, North Carolina, United States, 27157 | |
| Principal Investigator: | Kathryn Weaver | Comprehensive Cancer Center of Wake Forest University |
More Information
No publications provided
| Responsible Party: | Comprehensive Cancer Center of Wake Forest University |
| ClinicalTrials.gov Identifier: | NCT01457469 History of Changes |
| Other Study ID Numbers: | CCCWFU 99310, NCI-2011-02410 |
| Study First Received: | October 21, 2011 |
| Last Updated: | January 31, 2013 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Carcinoma, Non-Small-Cell Lung Tobacco Use Disorder Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Substance-Related Disorders Mental Disorders Nicotine |
Nicotine polacrilex Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Central Nervous System Stimulants Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013