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OpenTrials
Completed

NCT Number: NCT02188563

A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers

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.

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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Head and Neck Neoplasms Health Behavior Lung Diseases Lung Neoplasms Mental Disorders Neoplasms Neoplasms by Site Radiation Respiratory Tract Diseases Respiratory Tract Neoplasms Smoking Cessation Substance-Related Disorders Thoracic Neoplasms

Age range

18 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Comprehensive smoking cessation intervention

Other

Enhanced Usual Care

Behavioral

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Jul 11, 2014
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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