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Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence (SHP)

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
New York State Department of Health
Greater Rochester Area Tobacco Cessation Center
Health Maintenance Consortium
National Institutes of Health (NIH)
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178685
First received: September 13, 2005
Last updated: January 15, 2013
Last verified: July 2009
History of Changes

September 13, 2005
January 15, 2013
August 2004
August 2008   (final data collection date for primary outcome measure)
12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention. [ Time Frame: 12 months after subject completes intervention. ] [ Designated as safety issue: No ]
The primary outcome measure was 12-month prolonged abstinence (12M-PA) assessed by patient self-report 12-months after the intervention ended. If participant responded that they had not smoked a cigarette, even a puff, in the last 7 days at 12 months post-intervention, and reported date of last cigarette was 365 days or more prior to assessment date, then they were considered to have 12 month prolonged abstinence. A baseline-observation-carried-forward (BOCF)strategy was used for missing data such that those not reporting smoking status 12 months post-intervention were considered smoking.
12 month prolonged abstinence from tobacco measured at 24 months from randomization.
Complete list of historical versions of study NCT00178685 on ClinicalTrials.gov Archive Site
7 Day Point Prevelence (7DPP) [ Time Frame: 12 months after the intervention ] [ Designated as safety issue: No ]
Seven-day point prevalence abstinence (7DPP) was assessed by asking: "Have you smoked a cigarette, even a puff, in the last 7 days?"16 Participants were also asked if they had smoked cigars or pipe, chewed tobacco, or used snuff in the past 7 days, and if they responded yes they were considered tobacco users.
Tobacco abstinence measured as a latent variable with the following three indicators: longest number of days not smoking, the number of days since last cigarette, and the 12 month prolonged abstinence.
Not Provided
Not Provided
 
Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence
Self-determination and Maintaining Tobacco Abstinence

These two studies will examine the role of autonomous motivation in maintained adherence. The first study will determine whether smokers are still abstinent from tobacco 32 months after starting in a previous project (Smoker's Health Study). The purpose of the second study is to determine which of three treatments for tobacco dependence provides the greatest amount of protection from relapsing to smoking after quitting. Specifically, the investigators will determine if extending the length of treatment time focusing on relapse prevention and arranging for support from important others prevents relapse compared to community care. Also, the investigators will determine if providing extended treatment time and support from important others plus providing medications to those that don't want to quit prevents long term relapse compared to just extending the length of treatment time and support from others. Additionally, a sub set of the population will be randomized to using hand held palm devices to recover real-time data assessment during the last 10 months of the project.

These two studies will extend our examination of self-determination theory (SDT) based counseling interventions to the issue of maintained abstinence from tobacco use. Two projects are proposed, both of which build on the results of our current trial. The first is a 32-month follow-up of the smoking status of patients in the preceding trial called the Smoker's Health Study (self-determination, smoking, diet, and health). That SDT intervention (4 counselor visits over 6 months) increased cessation at 6 months relative to community care, and was also effective in increasing 12 month prolonged abstinence, and the results have been reported in two manuscripts (Williams, McGregor, Sharp, Levesque, Kouides, Ryan, and Deci, In press; Williams, McGregor, Sharp, Levesque, Kouides, Ryan, and Deci, 2005). The part of this first project that will be conducted as part of this grant will be to complete 32 month follow-up of smokers in the Smoker's Health Study. The second project is a 3-cell clinical trial called the Smoker's Health Project that will examine two extensions of the current intervention, both of which place greater emphasis on use of, and adherence to, cessation medications. The two arms will be compared to community care. Both arms involve two visits with a physician to discuss medications and side effects. In both interventions, counselors will address medication adherence. The two arms differ in that patients not ready to quit in one arm will receive a smoking reduction approach (with medications) in which they first try to reduce their smoking to half and then attempt cessation. In addition, to place greater emphasis on medications and to examine medication adherence as a mediator of maintained cessation.

There will be two major changes in the intervention intended to facilitate long-term maintenance. First, the intervention will extend over 12 months (whereas the current one lasts only 6 months) with meetings during the additional 6 months focusing on maintenance and relapse prevention. Second, at least one family member or best friend of each patient will be encouraged to meet with a counselor to learn how to be more autonomy supportive with the patient around issues related to tobacco. Cessation and maintained abstinence will be examined with logistic regression. The SDT process model of maintained cessation will be tested using structural equation modeling, and cost-effectiveness analyses will be done for the interventions.
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Tobacco Use Disorder
Behavioral: Self-determination Intervention for Tobacco Dependence
autonomy supported behavioral intervention for tobacco dependent individuals
Other Name: Smokers' Health Project
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
837
August 2008
August 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Smoking 5 or more cigarettes per day.
  • 18 years of age or older.
  • Speak and read English.
  • Eligible regardless of desire to quit smoking

Exclusion Criteria:

  • Pregnancy
  • History of psychotic illness other than depression
  • Life expectancy of less than 24 months
  • Dementia, or incompetence for medical decision making
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00178685
10085, R01 CA10666, 1R21CA119112-01A2
Not Provided
Geoffrey C Williams, University of Rochester, Smokers' Health Project
University of Rochester
  • National Cancer Institute (NCI)
  • New York State Department of Health
  • Greater Rochester Area Tobacco Cessation Center
  • Health Maintenance Consortium
  • National Institutes of Health (NIH)
Principal Investigator: Geoffrey C Williams, MD, Ph.D. University of Rochester
University of Rochester
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP