title: Trial design: The St. Jude Children's Research Hospital Cancer Survivors Tobacco Quit Line study.
abstract: 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.
authors.affiliation: Department of Epidemiology and Cancer Control, St. Jude Children's Research Hospital, Memphis, TN 38105, USA. taghrid.asfar@stjude.org
authors.forename: Taghrid
authors.initials: T
authors.lastname: Asfar
authors.forename: Robert C
authors.initials: RC
authors.lastname: Klesges
authors.forename: Stacy D
authors.initials: SD
authors.lastname: Sanford
authors.forename: Deborah
authors.initials: D
authors.lastname: Sherrill-Mittleman
authors.forename: Leslie L
authors.initials: LL
authors.lastname: Robison
authors.forename: Melissa M
authors.initials: MM
authors.lastname: Hudson
authors.forename: Grant
authors.initials: G
authors.lastname: Somes
authors.forename: James M
authors.initials: JM
authors.lastname: Boyett
authors.forename: Harry
authors.initials: H
authors.lastname: Lando
mesh_terms: D000328:Adult; D001521:Behavior Therapy; D002648:Child; D003376:Counseling; D005260:Female; D005731:Ganglionic Stimulants / Q000008:administration & dosage; D015277:Hotlines; D006801:Humans; D008297:Male; D009369:Neoplasms / Q000534:rehabilitation*; D009538:Nicotine / Q000008:administration & dosage; D018579:Patient Selection; D012107:Research Design; D016540:Smoking Cessation; D017741:Survivors; D055815:Young Adult
chemical_list: D005731:Ganglionic Stimulants; D009538:Nicotine