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Efficacy of Tobacco Quitline for Childhood Cancer Survivors - NCT00827866-38105(Clinical Trial 265180)



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City:  Memphis
State:  
TN
Zip Code: 38105
Conditions: Smoking Cessation
Purpose: The proposed study is a two-armed randomized controlled clinical trial examining the long-term (one-year)efficacy of telephone intervention conditions for smoking cessation in a high risk medical population; namely,adult survivors of childhood cancer. Proactive telephone recruitment through the Childhood Cancer Survivors Survey (CCSS) will serve as the method of recruitment.
Study summary: In this study participants (n=950) will be randomly assigned to a Counselor-Initiated Tobacco Quit Line (QL;) in which the counselor contacts the client with the standardized intervention protocol, or a Self-Paced Tobacco QL (which leaves the calling up to participants).The proposed active intervention will be a the Counselor-Initiated QL which includes 8 weeksof nicotine replacement therapy (NRT) and six scheduled telephone sessions of a behavioral intervention. The comparison condition will be the Self-Paced QL with provision of 2 weeks of NRT and encouraged obtainment of additional NRT. If participants in the Self-Paced condition make all six calls, they will receive the same behavioral intervention as in the Counselor-Initiated condition.
Criteria: Inclusion Criteria: - Childhood cancer survivor diagnosed before the age of 21 - Have been smoking for at least one year. - Participants must be at least 18 years of age or older. - Participants must be at least one year out of active cancer treatment - Any histologic subtype of childhood cancer will qualify for entry into this study. - Participants must speak English - Participants must have access to a telephone for participation. Exclusion Criteria: - Inability to understand consent procedures - Participants with a known contraindication or sensitivity to nicotine replacement therapy may participate in this study; however they will not receive nicotine replacement therapy (NRT) as part of their smoking cessation program. - Since our participants are childhood cancer survivors and they can be medically fragile and we are interested in providing all eligible participants with NRT to enhance their ability to quit smoking, we added a cautionary conditions list to the recruitment screening form. Those with severe arrhythmias, myocardial infarction, unstable angina, cerebrovascular incident, blood vessel disease, phaeochromocytoma, diabetes, hyperthyroidism, abnormal kidney or liver function, or history of gastritis or peptic ulcers, or who smoke less than 5 cigarettes per day will not receive NRT. - Patients with questionable NRT eligibility will be discussed/reviewed on a case by case basis with the Staff Family Physician
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Data Source: ClinicalTrials.gov
Date Processed: July 21, 2010
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