Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
946 participants
INTERVENTIONAL
2008-10-31
2013-11-30
Brief Summary
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The specific aims of the study :
(1) To recruit nationally a cohort of approximately 1242 smokers who are cancer survivors(621 childhood cancer survivors and 621 adult cancer survivors); 2) To determine the long-term (one year) efficacy of the intervention condition for participants randomly assigned to the Counselor-initiated versus a Self-paced QL; and (3) to find out whether treatment outcomes vary as a function of survivors' age of cancer diagnosis (survivors who diagnosed while adults vs. childhood cancer survivors who diagnosed before the age of 21).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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1
Counselor-Initiated Tobacco Quit Line Group QL where the counselor contacts the client with a standardized intervention protocol)
Counselor-Initiated Tobacco Quit Line
The proposed active intervention will be a the Counselor-Initiated QL which includes provision of 8 weeks of nicotine replacement therapy (NRT) and six scheduled telephone sessions of a behavioral intervention.
2
Self-Paced Tobacco Quit Line Group which leaves the calling up to participants
Self-Paced Tobacco Quit Line
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.
Interventions
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Counselor-Initiated Tobacco Quit Line
The proposed active intervention will be a the Counselor-Initiated QL which includes provision of 8 weeks of nicotine replacement therapy (NRT) and six scheduled telephone sessions of a behavioral intervention.
Self-Paced Tobacco Quit Line
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants is a cancer survivor
* Participant must be at least 18 years of age.
* Childhood cancer survivors must be at least one year out active cancer treatment.
* Participant understands consent procedures.
* Participant speaks English.
* Participant must have access to a telephone for participation
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
St. Jude Children's Research Hospital
OTHER
Responsible Party
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Principal Investigators
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Robert C Klesges, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Jude Children's Research Hospital
Locations
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St. Jude Children's Research Hospital
Memphis, Tennessee, United States
Countries
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References
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Klesges RC, Krukowski RA, Klosky JL, Liu W, Srivastava DK, Boyett JM, Lanctot JQ, Hudson MM, Folsom C, Lando H, Robison LL. Efficacy of a tobacco quitline among adult cancer survivors. Prev Med. 2015 Apr;73:22-7. doi: 10.1016/j.ypmed.2014.12.019. Epub 2015 Jan 5.
Related Links
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St. Jude Children's Research Hospital
Other Identifiers
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XPD07-140 Quit-Line
Identifier Type: -
Identifier Source: org_study_id