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

Taghrid Asfar, Robert C. Klesges, Stacy D. Sanford, Deborah Sherrill-Mittleman, Leslie L. Robison, Melissa M. Hudson, Grant Somes, James M. Boyett, Harry Lando

Research output: Contribution to journalArticlepeer-review

15 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)82-91
Number of pages10
JournalContemporary Clinical Trials
Issue number1
StatePublished - Jan 2010

Bibliographical note

Funding Information:
This study described in this manuscript is supported by research grants ( R01CA127964-01A1 ) from the National Cancer Institute .


  • Childhood cancer survivors
  • Cotinine-validated smoking abstinence
  • Counselor initiated intervention
  • Long-term efficacy
  • Participant initiated intervention
  • Randomized controlled clinical trial
  • Smoking cessation intervention
  • Tobacco quit lines


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