Back to resultsA Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers
Primary Purpose
Tobacco Use Disorder, Head and Neck Neoplasms, Thoracic Neoplasms
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Comprehensive smoking cessation intervention
Enhanced usual care
Sponsored by
About this trial
This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Smoking cessation, Head and neck neoplasms, Lung neoplasms, Thoracic neoplasms, Radiation
Eligibility 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
Sites / Locations
- Johns Hopkins Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Comprehensive intervention
Enhanced usual care
Arm Description
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 consistent with the U.S. Department of Health and Human Services guidelines for tobacco treatment.
Outcomes
Primary Outcome Measures
Smoking cessation
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02188563
First Posted
July 7, 2014
Last Updated
January 15, 2019
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
1. Study Identification
Unique Protocol Identification Number
NCT02188563
Brief Title
A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers
Official Title
Efficacy and Impact of a Comprehensive Smoking Cessation Intervention During Radiation for Upper Aerodigestive Cancers
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR)
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder, Head and Neck Neoplasms, Thoracic Neoplasms, Radiation
Keywords
Smoking cessation, Head and neck neoplasms, Lung neoplasms, Thoracic neoplasms, Radiation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Comprehensive intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Enhanced usual care
Arm Type
Active Comparator
Arm Description
Intervention consistent with the U.S. Department of Health and Human Services guidelines for tobacco treatment.
Intervention Type
Other
Intervention Name(s)
Comprehensive smoking cessation intervention
Intervention Type
Behavioral
Intervention Name(s)
Enhanced usual care
Primary Outcome Measure Information:
Title
Smoking cessation
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gypsyamber D'Souza, PhD
Organizational Affiliation
Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33605440
Citation
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(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.
Results Reference
derived
Learn more about this trial
A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers
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