NCT02188563CompletedNot Applicable
Efficacy and Impact of a Comprehensive Smoking Cessation Intervention During Radiation for Upper Aerodigestive Cancers
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins2 sites in 1 country30 target enrollmentStarted: May 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Smoking cessation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 105 Years (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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