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Sponsors and Collaborators: |
St. Jude Children's Research Hospital National Cancer Institute (NCI) |
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Information provided by: | St. Jude Children's Research Hospital |
ClinicalTrials.gov Identifier: | NCT00827866 |
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. 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 provision of free 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.
Condition | Intervention |
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Smoking Cessation |
Other: Counselor-Initiated Tobacco Quit Line Other: Self-Paced Tobacco Quit Line |
Study Type: | Interventional |
Study Design: | Open Label, Parallel Assignment |
Official Title: | Efficacy of Tobacco Quitline for Childhood Cancer Survivors |
Estimated Enrollment: | 950 |
Study Start Date: | October 2008 |
Estimated Study Completion Date: | October 2013 |
Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Counselor-Initiated Tobacco Quit Line Group
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Other: Counselor-Initiated Tobacco Quit Line
Counselor-Initiated Tobacco Quit Line
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2
Self-Paced Tobacco Quit Line Group
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Other: Self-Paced Tobacco Quit Line
Self-Paced Tobacco Quit Line
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Robert C Klesges, PhD | 1-866-278-5833 | info@stjude.org |
United States, Tennessee | |
St. Jude Children's Research Hospital | Recruiting |
Memphis, Tennessee, United States, 38105 | |
Contact: Robert C Klesges, PhD | |
Principal Investigator: Robert C Klesges, PhD |
Principal Investigator: | Robert C Klesges, PhD | St. Jude Children's Research Hospital |
Responsible Party: | St. Jude Children's Research Hospital ( Robert C. Klesges, PhD ) |
Study ID Numbers: | XPD07-140 |
Study First Received: | January 21, 2009 |
Last Updated: | June 17, 2009 |
ClinicalTrials.gov Identifier: | NCT00827866 History of Changes |
Health Authority: | United States: Institutional Review Board |
Smoking |