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A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers

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ClinicalTrials.gov Identifier: NCT02188563
Recruitment Status : Completed
First Posted : July 11, 2014
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Tracking Information
First Submitted Date  ICMJE July 7, 2014
First Posted Date  ICMJE July 11, 2014
Last Update Posted Date January 17, 2019
Study Start Date  ICMJE May 2014
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2014)
Smoking cessation [ Time Frame: 8 weeks ]
Smoking cessation will be defined as BOTH (1) self-reported 7-day abstinence from smoking and (2) exhaled carbon monoxide level of 8 or lower as biochemical confirmation of abstinence.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers
Official Title  ICMJE Efficacy and Impact of a Comprehensive Smoking Cessation Intervention During Radiation for Upper Aerodigestive Cancers
Brief Summary Smoking is the greatest risk factor for upper aerodigestive cancers (thoracic or head and neck) and negatively impacts survival and other outcomes, but many patients have difficulty quitting after their diagnosis. Smoking cessation interventions for cancer patients thus far have had limited success. This is a pilot randomized controlled trial designed to determine if a new comprehensive, evidence-based smoking cessation intervention can improve quit rates for cancer patients who smoke.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tobacco Use Disorder
  • Head and Neck Neoplasms
  • Thoracic Neoplasms
  • Radiation
Intervention  ICMJE
  • Other: Comprehensive smoking cessation intervention
  • Behavioral: Enhanced usual care
Study Arms  ICMJE
  • Experimental: Comprehensive intervention
    New evidence-based comprehensive smoking cessation intervention including several elements that have proven successful in non-cancer patients but not used for cancer patients before.
    Intervention: Other: Comprehensive smoking cessation intervention
  • Active Comparator: Enhanced usual care
    Intervention consistent with the U.S. Department of Health and Human Services guidelines for tobacco treatment.
    Intervention: Behavioral: Enhanced usual care
Publications * Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2:CD005084. doi: 10.1002/14651858.CD005084.pub4.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 20, 2015)
30
Original Estimated Enrollment  ICMJE
 (submitted: July 9, 2014)
180
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • New diagnosis of head and neck or thoracic (including lung) cancer
  • Undergoing radiation at Johns Hopkins Radiation Oncology for 5 or more weeks
  • English-speaking and able to provide informed consent
  • Smoked any cigarettes in previous 14 days

Exclusion Criteria:

  • Palliative radiation
  • Undergoing stereotactic radiosurgery
  • Pregnant or breastfeeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 105 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02188563
Other Study ID Numbers  ICMJE J1407
NA_00089912 ( Other Identifier: JHM IRB )
P50DE019032 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Sponsor  ICMJE Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators  ICMJE National Institute of Dental and Craniofacial Research (NIDCR)
Investigators  ICMJE
Principal Investigator: Gypsyamber D'Souza, PhD Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology
PRS Account Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP