Trial design: The St. Jude Children's Research Hospital Cancer Survivors Tobacco Quit Line study.

Nearly, one-fifth of childhood cancer survivors (CCSs) smoke cigarettes. Because CCSs are already at greater medical smoking-related risks, targeting them for smoking cessation efforts is a high priority. One of the major challenges with smoking cessation in CCSs is how to reach such a geographically dispersed population. This study aims to demonstrate that these challenges can be overcome through the use of telephone-based tobacco quit lines (QLs). This report describes the design of the St. Jude Cancer Survivor Tobacco QL study, which is a randomized controlled clinical trial that will examine the long-term (1-year) efficacy of a counselor initiated vs. participant initiated tobacco QL with adjunctive nicotine replacement therapy (NRT) in both groups. Participants (N=950) will be recruited nationally and randomly assigned to one of the two interventions. The counselor initiated intervention includes six scheduled telephone sessions of a behavioral intervention and provision of 8 weeks of NRT. The participant initiated intervention allows the participant to call the QL at their convenience, but includes the same six telephone sessions and provision of 2 weeks of NRT. Both groups will receive two follow-up phone calls at 8 weeks and 1 year after enrollment to assess their smoking status. The primary outcome measure is cotinine-validated self-reported smoking abstinence at 1-year follow-up. Results from this study will provide the first evidence about the efficacy of intensive QL cessation intervention in this high-risk population. Such evidence can lead as well to the dissemination of this intervention to other medically compromised populations.