ClinicalTrials.gov
ClinicalTrials.gov Menu

Tobacco Treatment for Employable Californians, Total IMPACT Study (TTEC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02478697
Recruitment Status : Recruiting
First Posted : June 23, 2015
Last Update Posted : April 21, 2016
Sponsor:
Collaborators:
San Francisco Employment Development Department
Marin Employment Connection
JobTrain
Information provided by (Responsible Party):
Judith Prochaska, Stanford University

Brief Summary:
Previous findings indicate elevated risk for tobacco use among adults in California who are unemployed and seeking work. In a pilot study, tobacco use was associated with a longer duration of time out of work. This community-based participatory research study aims to deliver and evaluate the impact of a web-based job seeker tailored tobacco cessation intervention vs. a control group in the San Francisco Bay Area. This research investigates whether an employment-centered tobacco treatment intervention is efficacious in supporting abstinence and also associated with more timely engagement of employment.

Condition or disease Intervention/treatment Phase
Tobacco Dependence Behavioral: ProChange ExpertSystem Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tobacco Treatment for Employable Californians (TTEC), Improving Employability Partnership: Alliance to Curb Tobacco (Total IMPACT)
Study Start Date : October 2015
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: Tobacco Treatment
The tobacco treatment includes: (a) the ProChange ExpertSystem, a Transtheoretical-model (TTM) tailored, computer-assisted web-delivered program focused on increasing intrinsic motivation, (b) a stage-tailored treatment manual with goal setting for quitting tobacco, and (c) education on proper use of nicotine replacement therapy (NRT, patch plus gum or lozenge) with guidance on obtaining low-cost or free NRT through MediCal, private insurance plans, and community programs.
Behavioral: ProChange ExpertSystem
The computer program assesses stage of change and TTM constructs of temptations, decisional balance, and processes of change. Repeat intervention contacts occur at baseline, 3- and 6-months follow-up, providing iterative computerized feedback reflecting prior responses with encouragement for quitting smoking and relapse prevention.
Other Name: ProChange

No Intervention: Usual Care
Usual care includes: completing the study assessments at baseline, 3- and 6-months and receiving referrals to tobacco treatment in the community, including the state quitline, in line with the public health "Ask, Advise, Refer" model of tobacco cessation intervention.



Primary Outcome Measures :
  1. Smoking Status: 7-day point prevalence abstinence [ Time Frame: 3-months follow-up ]
    Past 7-day use of conventional cigarettes, alternative tobacco (smokeless, snus), and electronic nicotine devices (ENDS, e.g., e-cigarettes) with details on cigarettes/day, frequency, brand, flavor, strength, and quit attempts. For biochemical verification, participants reporting 7-day PPA at follow-up will have an expired CO sample evaluated using a Bedfont Smokerlyzer. Participants with CO < 8 ppm indicating nonsmoking will provide a saliva sample for testing with of cotinine with an Accutest NicAlertTM test strip. Salivary cotinine levels < 15 ng/ml will confirm nonsmoking. Additionally, participants reporting being quit will be asked to provide a urine sample to test for the presence of anabasine (if they have quit smoking but are still using nicotine replacement or another nicotine containing product).

  2. Smoking Status: 7-day point prevalence abstinence [ Time Frame: 6-months follow-up ]
    Past 7-day use of conventional cigarettes, alternative tobacco (smokeless, snus), and electronic nicotine devices (ENDS, e.g., e-cigarettes) with details on cigarettes/day, frequency, brand, flavor, strength, and quit attempts. For biochemical verification, participants reporting 7-day PPA at follow-up will have an expired CO sample evaluated using a Bedfont Smokerlyzer. Participants with CO < 8 ppm indicating nonsmoking will provide a saliva sample for testing with of cotinine with an Accutest? NicAlertTM test strip. Salivary cotinine levels < 15 ng/ml will confirm nonsmoking. Additionally, participants reporting being quit will be asked to provide a urine sample to test for the presence of anabasine (if they have quit smoking but are still using nicotine replacement or another nicotine containing product).

  3. Time to find employment (weeks) [ Time Frame: 6-months ]
    How quickly participants find employment, measured in weeks


Secondary Outcome Measures :
  1. 3-month Prolonged Abstinence [ Time Frame: 6-months follow-up ]
    3-mo prolonged abstinence from the 3- to 6-mo assessment, applying NHLBI's definition of relapse (i.e., smoking on 7 consecutive days or smoking at least once each week over 2 consecutive weeks);42 reduction in cigarettes per week; and given the uncertainty in the field with respect to how to treat ENDS, will examine the proportion of the sample abstinent from conventional cigarettes and all tobacco, allowing for ENDS use.

  2. Employment Status [ Time Frame: 3-months follow-up ]
    Whether a participant is working or not at the time of assessment.

  3. Employment Status [ Time Frame: 6-months follow-up ]
    Whether a participant is working or not at the time of assessment.

  4. Employment Status [ Time Frame: 6-months follow-up ]
    Whether the participant was able to secure employment at any point within the study.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria: Study eligibility will be defined as unemployed and job seeking at a participating America's Job Centers of California (AJCC) organization and currently smoking 1 or more cigarettes daily and at least 100+ cigarettes in one's lifetime with a carbon monoxide (CO) breath sample of 10 ppm or greater. The CO sample will be taken prior to consenting potential participants. Participants must be 18 years or older, English literate, able to provide at least three collateral sources of contact for follow-up assessments, and not immediately planning to relocate out of California (though researchers would continue to follow-up with participants who move out of area, and have demonstrated success with doing so in prior studies). Dual use of e-cigarettes will not be an exclusion criterion.

Exclusion Criteria: Failure to meet inclusion criteria; non-job-seeking, persons employed or underemployed, occasional/non-daily smokers, daily smokers with carbon monoxide readings less than 10ppm, nonsmokers.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02478697


Contacts
Contact: Judith J Prochaska, PhD, MPH 650-724-3608 jpro@stanford.edu

Locations
United States, California
JobTrain Recruiting
Menlo Park, California, United States, 94025
Contact: Cati Brown-Johnson, PhD    650-721-1846      
San Francisco Employment Development Department Recruiting
San Francisco, California, United States, 94102
Contact: Cati Brown-Johnson, PhD    650-721-1846      
Marin Employment Connection Recruiting
San Rafael, California, United States, 94903
Contact: Cati Brown-Johnson, PhD    650-721-1846      
Sponsors and Collaborators
Stanford University
San Francisco Employment Development Department
Marin Employment Connection
JobTrain
Investigators
Principal Investigator: Judith J Prochaska, PhD, MPH Stanford University

Publications:

Responsible Party: Judith Prochaska, Associate Professor, Stanford University
ClinicalTrials.gov Identifier: NCT02478697     History of Changes
Other Study ID Numbers: 24RT-0035
First Posted: June 23, 2015    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: April 2016

Keywords provided by Judith Prochaska, Stanford University:
tobacco smoking behavior
employment
job-seeking
tobacco cessation
transtheoretical model
behavior change

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders