NCT02188563

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 17, 2019

Status Verified

May 1, 2015

Enrollment Period

1 year

First QC Date

July 7, 2014

Last Update Submit

January 15, 2019

Conditions

Tobacco Use DisorderHead and Neck NeoplasmsThoracic NeoplasmsRadiation

Keywords

Smoking cessationHead and neck neoplasmsLung neoplasmsThoracic neoplasmsRadiation

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Comprehensive intervention

EXPERIMENTAL

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

Enhanced usual care

ACTIVE COMPARATOR

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

Behavioral: Enhanced usual care

Interventions

Comprehensive smoking cessation interventionOTHER
Comprehensive intervention
Enhanced usual careBEHAVIORAL
Enhanced usual care

Eligibility Criteria

Age18 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Palliative radiation
  • Undergoing stereotactic radiosurgery
  • Pregnant or breastfeeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Medicine

Baltimore, Maryland, 21287, United States

Location

Related Publications (1)

  • 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.

    PMID: 33605440DERIVED

MeSH Terms

Conditions

Tobacco Use DisorderHead and Neck NeoplasmsThoracic NeoplasmsSmoking CessationLung Neoplasms

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersNeoplasms by SiteNeoplasmsHealth BehaviorBehaviorRespiratory Tract NeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Gypsyamber D'Souza, PhD

    Johns Hopkins Bloomberg School of Public Health, Department of Epidemiology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2014

First Posted

July 11, 2014

Study Start

May 1, 2014

Primary Completion

May 1, 2015

Study Completion

May 1, 2016

Last Updated

January 17, 2019

Record last verified: 2015-05

Locations

US(1)