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A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Head and Neck Neoplasms Thoracic Neoplasms Radiation Other: Comprehensive smoking cessation intervention Behavioral: Enhanced usual care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Impact of a Comprehensive Smoking Cessation Intervention During Radiation for Upper Aerodigestive Cancers
Study Start Date : May 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2016

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Arms and Interventions
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Arm Intervention/treatment
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.
 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.
 Behavioral: Enhanced usual care


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02188563


Locations
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United States, Maryland
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
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Principal Investigator: Gypsyamber D'Souza, PhD Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology
More Information
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Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
ClinicalTrials.gov Identifier: NCT02188563    
Other Study ID Numbers: J1407
NA_00089912 ( Other Identifier: JHM IRB )
P50DE019032 ( U.S. NIH Grant/Contract )
First Posted: July 11, 2014    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: May 2015
Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins:
Smoking cessation
Head and neck neoplasms
Lung neoplasms
Thoracic neoplasms
Radiation
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Thoracic Neoplasms
Tobacco Use Disorder
Neoplasms
 Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Neoplasms by Site