A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers

Not Applicable

Completed

• Conditions: Tobacco Use Disorder; Head and Neck Neoplasms; Radiation; Thoracic Neoplasms
• Interventions: Other: Comprehensive smoking cessation intervention; Behavioral: Enhanced usual care

• Registration Number: NCT02188563
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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 available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-07-07
• Study First Submitted QC: 2014-07-09
• Study First Posted: 2014-07-11
• Status Verified: 2015-05
• Primary Completion: 2015-05
• Study Completion: 2016-05
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive intervention	Comprehensive smoking cessation 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.
Enhanced usual care	Enhanced usual care	Intervention consistent with the U.S. Department of Health and Human Services guidelines for tobacco treatment.

Primary Outcome Measures

Name	Time	Method
Smoking cessation	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.

Trial Locations

Locations (1)

Johns Hopkins Medicine; 🇺🇸 Baltimore, Maryland, United States