A Comprehensive Smoking Cessation Intervention Duration Radiation for Upper Aerodigestive Cancers

NCT ID: NCT02188563

Last Updated: 2019-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tobacco Use Disorder Head and Neck Neoplasms Thoracic Neoplasms Radiation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Comprehensive smoking cessation intervention

Intervention Type OTHER

Enhanced usual care

Intervention consistent with the U.S. Department of Health and Human Services guidelines for tobacco treatment.

Group Type ACTIVE_COMPARATOR

Enhanced usual care

Intervention Type BEHAVIORAL

Interventions

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Comprehensive smoking cessation intervention

Intervention Type OTHER

Enhanced usual care

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gypsyamber D'Souza, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology

Locations

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Johns Hopkins Medicine

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.

Reference Type DERIVED
PMID: 33605440 (View on PubMed)

Other Identifiers

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NA_00089912

Identifier Type: OTHER

Identifier Source: secondary_id

P50DE019032

Identifier Type: NIH

Identifier Source: secondary_id

View Link

J1407

Identifier Type: -

Identifier Source: org_study_id

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