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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.

SUBMITTER: Asfar T

PROVIDER: S-EPMC2818168 | biostudies-literature | 2010 Jan

REPOSITORIES: biostudies-literature

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

Asfar Taghrid T Klesges Robert C RC Sanford Stacy D SD Sherrill-Mittleman Deborah D Robison Leslie L LL Hudson Melissa M MM Somes Grant G Boyett James M JM Lando Harry H

Contemporary clinical trials 20090918 1

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. Ju ...[more]

PMID: 19766734

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Project description:Methylation profiling has radically transformed our understanding of tumors previously called central nervous system primitive neuro-ectodermal tumors (CNS-PNET). While this marks a momentous step toward defining key differences, reclassification has thrown treatment into disarray. To shed light on response to therapy and guide clinical decision-making, we report outcomes and molecular features of children with CNS-PNETs from two multi-center risk-adapted studies (SJMB03 for patients ≥ 3 years; SJYC07 for patients < 3 years) complemented by a non-protocol institutional cohort. Seventy patients who had a histological diagnosis of CNS-PNET or CNS embryonal tumor from one of the new categories that has supplanted CNS-PNET were included. This cohort was molecularly characterized by DNA methylation profiling (n = 70), whole-exome sequencing (n = 53), RNA sequencing (n = 20), and germline sequencing (n = 28). Clinical characteristics were detailed, and treatment was divided into craniospinal irradiation (CSI)-containing (SJMB03 and SJMB03-like) and CSI-sparing therapy (SJYC07 and SJYC07-like). When the cohort was analyzed in its entirety, no differences were observed in the 5-year survival rates even when CSI-containing therapy was compared to CSI-sparing therapy. However, when analyzed by DNA methylation molecular grouping, significant survival differences were observed, and treatment particulars provided suggestions of therapeutic response. Patients with CNS neuroblastoma with FOXR2 activation (CNS-NB-FOXR2) had a 5-year event-free survival (EFS)/overall survival (OS) of 66.7% ± 19.2%/83.3% ± 15.2%, and CIC rearranged sarcoma (CNS-SARC-CIC) had a 5-year EFS/OS both of 57.1% ± 18.7% with most receiving regimens that contained radiation (focal or CSI) and multidrug chemotherapy. Patients with high-grade neuroepithelial tumor with BCOR alteration (HGNET-BCOR) had abysmal responses to upfront chemotherapy-only regimens (5-year EFS = 0%), but survival extended with salvage radiation after progression [5-year OS = 53.6% ± 20.1%]. Patients with embryonal tumor with multilayered rosettes (ETMR) or high-grade glioma/glioblastoma multiforme (HGG/GBM) did not respond favorably to any modality (5-year EFS/OS = 10.7 ± 5.8%/17.9 ± 7.2%, and 10% ± 9.0%/10% ± 9.0%, respectively). As an accompaniment, we have assembled this data onto an interactive website to allow users to probe and query the cases. By reporting on a carefully matched clinical and molecular cohort, we provide the needed insight for future clinical management.

Dataset Information

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

Publications

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

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