Efficacy of Tobacco Quitline for Cancer Survivors
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, cancer survivors: Proactive telephone recruitment through the Childhood Cancer Survivors Survey (CCSS) St. Jude Life Study, After Completion of Therapy (ACT) Clinic and face to face recruitment at the local West Clinics will serve as the primary methods of recruitment.
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).
|Smoking Cessation||Other: Counselor-Initiated Tobacco Quit Line Other: Self-Paced Tobacco Quit Line|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Efficacy of Tobacco Quitline for Cancer Survivors|
- Self-reported prolonged abstinence and cotinine-validated point-prevalence abstinence at 1 year follow-up [ Time Frame: 1 year ]
- Account for dose of treatment (NRT use plus number of QL contact) vs. success(quit for one year response) independent of treatment assignment [ Time Frame: 1 year ]
|Study Start Date:||October 2008|
|Study Completion Date:||November 2013|
|Primary Completion Date:||November 2013 (Final data collection date for primary outcome measure)|
Counselor-Initiated Tobacco Quit Line Group QL where the counselor contacts the client with a standardized intervention protocol)
Other: 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.
Other Name: Other: Arm 1
Self-Paced Tobacco Quit Line Group which leaves the calling up to participants
Other: 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 Name: Arm 2
Please refer to this study by its ClinicalTrials.gov identifier: NCT00827866
|United States, Tennessee|
|St. Jude Children's Research Hospital|
|Memphis, Tennessee, United States, 38105|
|Principal Investigator:||Robert C Klesges, PhD||St. Jude Children's Research Hospital|