A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers

January 15, 2019 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Efficacy and Impact of a Comprehensive Smoking Cessation Intervention During 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 105 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Comprehensive 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.
Other: Comprehensive smoking cessation intervention
Active Comparator: Enhanced usual care
Intervention consistent with the U.S. Department of Health and Human Services guidelines for tobacco treatment.
Behavioral: Enhanced usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

National Institute of Dental and Craniofacial Research (NIDCR)

Investigators

  • Principal Investigator: Gypsyamber D'Souza, PhD, Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

July 7, 2014

First Submitted That Met QC Criteria

July 9, 2014

First Posted (Estimate)

July 11, 2014

Study Record Updates

Last Update Posted (Actual)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J1407
  • NA_00089912 (Other Identifier: JHM IRB)
  • P50DE019032 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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