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NCT02188563 Clinical Trial

A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers

Tobacco Use Disorder Clinical Trial

Official title:
Efficacy and Impact of a Comprehensive Smoking Cessation Intervention During Radiation for Upper Aerodigestive Cancers

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02188563
Other study ID # J1407
Secondary ID NA_00089912P50DE
Status Completed
Phase N/A
First received
Last updated
Start date May 2014
Est. completion date May 2016

Study information
Verified date May 2015
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date May 2016
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 105 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Comprehensive smoking cessation intervention

Behavioral:
• Enhanced usual care

Locations
Country Name City State
United States Johns Hopkins Medicine Baltimore Maryland

Sponsors (2)
Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 8 weeks
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