Tobacco Treatment for Employable Californians, Total IMPACT Study

NCT02478697 | Completed

• 1 other identifier: 24RT-0035
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 3

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.

Conditions

Tobacco Dependence

Keywords

tobacco smoking behavior; employment; job-seeking; tobacco cessation; transtheoretical model; behavior change

Outcome Measures

Primary Outcomes (3)

• Smoking Status: 7-day point prevalence abstinence

  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-months follow-up

• Smoking Status: 7-day point prevalence abstinence

  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).

  6-months follow-up

• Time to find employment (weeks)

  How quickly participants find employment, measured in weeks

  6-months

Secondary Outcomes (4)

• 3-month Prolonged Abstinence

  6-months follow-up

• Employment Status

  3-months follow-up

• Employment Status - Current

  6-months follow-up

• Employment Status - Within study period

  6-months follow-up

Study Arms (2)

Tobacco Treatment

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

ProChange ExpertSystem BEHAVIORAL

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.

Also known as: ProChange

Tobacco Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Stanford University: lead
• San Francisco Employment Development Department: collaborator
• CareerPoint Marin: collaborator
• JobTrain: collaborator
• Marin City Community Development Corporation: collaborator
• Oakland Employment Development Department: collaborator

Study Sites (3)

JobTrain

Menlo Park, California, 94025, United States

Location

San Francisco Employment Development Department

San Francisco, California, 94102, United States

Location

Marin Employment Connection

San Rafael, California, 94903, United States

Location

Related Publications (9)

• Hall SM, Tsoh JY, Prochaska JJ, Eisendrath S, Rossi JS, Redding CA, Rosen AB, Meisner M, Humfleet GL, Gorecki JA. Treatment for cigarette smoking among depressed mental health outpatients: a randomized clinical trial. Am J Public Health. 2006 Oct;96(10):1808-14. doi: 10.2105/AJPH.2005.080382.

  PMID: 17008577 BACKGROUND

• Prochaska JJ, Rossi JS, Redding CA, Rosen AB, Tsoh JY, Humfleet GL, Eisendrath SJ, Meisner MR, Hall SM. Depressed smokers and stage of change: implications for treatment interventions. Drug Alcohol Depend. 2004 Nov 11;76(2):143-51. doi: 10.1016/j.drugalcdep.2004.04.017.

  PMID: 15488338 BACKGROUND

• Hughes JR, Keely JP, Niaura RS, Ossip-Klein DJ, Richmond RL, Swan GE. Measures of abstinence in clinical trials: issues and recommendations. Nicotine Tob Res. 2003 Feb;5(1):13-25.

  PMID: 12745503 BACKGROUND

• Jarvis MJ, Tunstall-Pedoe H, Feyerabend C, Vesey C, Saloojee Y. Comparison of tests used to distinguish smokers from nonsmokers. Am J Public Health. 1987 Nov;77(11):1435-8. doi: 10.2105/ajph.77.11.1435.

  PMID: 3661797 BACKGROUND

• Patten CA, Martin JE, Filter KJ, Wolter TD. Utility and accuracy of collateral reports of smoking status among 256 abstinent alcoholic smokers treated for smoking cessation. Addict Behav. 2002 Sep-Oct;27(5):687-96. doi: 10.1016/s0306-4603(01)00202-7.

  PMID: 12201377 BACKGROUND

• Adler NE, Epel ES, Castellazzo G, Ickovics JR. Relationship of subjective and objective social status with psychological and physiological functioning: preliminary data in healthy white women. Health Psychol. 2000 Nov;19(6):586-92. doi: 10.1037//0278-6133.19.6.586.

  PMID: 11129362 BACKGROUND

• Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.

  PMID: 1932883 BACKGROUND

• DiClemente CC, Prochaska JO, Fairhurst SK, Velicer WF, Velasquez MM, Rossi JS. The process of smoking cessation: an analysis of precontemplation, contemplation, and preparation stages of change. J Consult Clin Psychol. 1991 Apr;59(2):295-304. doi: 10.1037//0022-006x.59.2.295.

  PMID: 2030191 BACKGROUND

• Hall SM, Havassy BE, Wasserman DA. Commitment to abstinence and acute stress in relapse to alcohol, opiates, and nicotine. J Consult Clin Psychol. 1990 Apr;58(2):175-81. doi: 10.1037//0022-006x.58.2.175.

  PMID: 2335634 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking; Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior; Health Behavior

Study Officials

• Judith J Prochaska, PhD, MPH

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 16, 2015
• First Posted: June 23, 2015
• Study Start: October 1, 2015
• Primary Completion: September 12, 2018
• Study Completion: September 12, 2018
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

US (3)