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

Arm | Intervention/treatment |
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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.
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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.
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Behavioral: Enhanced usual care |
- 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.

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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 |
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

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
United States, Maryland | |
Johns Hopkins Medicine | |
Baltimore, Maryland, United States, 21287 |
Principal Investigator: | Gypsyamber D'Souza, PhD | Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology |
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 |
Smoking cessation Head and neck neoplasms Lung neoplasms Thoracic neoplasms Radiation |
Neoplasms Head and Neck Neoplasms Thoracic Neoplasms Tobacco Use Disorder |
Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Neoplasms by Site |