This trial is active, not recruiting.

Conditions tobacco use disorder, head and neck neoplasms, thoracic neoplasms, radiation
Treatments comprehensive smoking cessation intervention, enhanced usual care
Sponsor Sidney Kimmel Comprehensive Cancer Center
Start date May 2014
End date May 2015
Trial size 30 participants
Trial identifier NCT02188563, J1407, NA_00089912


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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.
comprehensive smoking cessation intervention
(Active Comparator)
Intervention consistent with the U.S. Department of Health and Human Services guidelines for tobacco treatment.
enhanced usual care

Primary Outcomes

Smoking cessation
time frame: 8 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Efficacy and Impact of a Comprehensive Smoking Cessation Intervention During Radiation for Upper Aerodigestive Cancers
Principal investigator Gypsyamber D'Souza, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.