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

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ClinicalTrials.gov Identifier: NCT00178685
Recruitment Status : Completed
First Posted : September 15, 2005
Results First Posted : February 15, 2013
Last Update Posted : February 15, 2013
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Tobacco Use Disorder
Intervention Behavioral: Self-determination Intervention for Tobacco Dependence
Enrollment 837
Recruitment Details Recruitment began in August 2004 and completed in September 2008. Subjects were consented in the research office.
Pre-assignment Details  
Arm/Group Title Community Care Extended Autonomy Support (EAS Harm Reduction (HR)
Hide Arm/Group Description The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready. The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy. The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
Period Title: Overall Study
Started 172 324 324
Completed 61 120 128
Not Completed 111 204 196
Reason Not Completed
Death             3             3             6
Lost to Follow-up             100             187             183
Withdrawal by Subject             8             14             7
Arm/Group Title Community Care Extended Autonomy Support (EAS Harm Reduction (HR) Total
Hide Arm/Group Description The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready. The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy. The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping. Total of all reporting groups
Overall Number of Baseline Participants 172 324 324 820
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 324 participants 324 participants 820 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
163
  94.8%
309
  95.4%
303
  93.5%
775
  94.5%
>=65 years
9
   5.2%
15
   4.6%
21
   6.5%
45
   5.5%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 172 participants 324 participants 324 participants 820 participants
47.74  (11.49614) 46.27  (12.14891) 48.32  (11.69470) 47.39  (11.69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 172 participants 324 participants 324 participants 820 participants
Female
98
  57.0%
194
  59.9%
196
  60.5%
488
  59.5%
Male
74
  43.0%
130
  40.1%
128
  39.5%
332
  40.5%
1.Primary Outcome
Title 12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention.
Hide Description 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.
Time Frame 12 months after subject completes intervention.
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Community Care Extended Autonomy Support (EAS Harm Reduction (HR)
Hide Arm/Group Description:
The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
Overall Number of Participants Analyzed 169 321 318
Measure Type: Number
Unit of Measure: participants
169 321 318
2.Secondary Outcome
Title 7 Day Point Prevelence (7DPP)
Hide Description 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.
Time Frame 12 months after the intervention
Hide Outcome Measure Data
Hide Analysis Population Description
820 individuals were randomized to condition, of those, 12 died during the course of the study (all deaths were found to be unrelated to the study). Final analysis number included all those randomized and excluded those who died during the study.
Arm/Group Title Community Care Extended Autonomy Support (EAS Harm Reduction (HR)
Hide Arm/Group Description:
The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
Overall Number of Participants Analyzed 169 321 318
Measure Type: Number
Unit of Measure: participants
169 321 318
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Community Care Extended Autonomy Support (EAS Harm Reduction (HR)
Hide Arm/Group Description The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready. The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy. The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
All-Cause Mortality
Community Care Extended Autonomy Support (EAS Harm Reduction (HR)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
Community Care Extended Autonomy Support (EAS Harm Reduction (HR)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/172 (2.33%)      3/324 (0.93%)      6/324 (1.85%)    
General disorders       
Death *  4/172 (2.33%)  4 3/324 (0.93%)  3 6/324 (1.85%)  6
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Community Care Extended Autonomy Support (EAS Harm Reduction (HR)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/172 (0.58%)      1/324 (0.31%)      0/324 (0.00%)    
General disorders       
Patient had adverse event while being treated for MS. Unrelated to smoking study. * [1]  1/172 (0.58%)  1 1/324 (0.31%)  1 0/324 (0.00%)  0
Social circumstances       
Dropped from study after patient quit smoking * [2]  1/172 (0.58%)  1 1/324 (0.31%)  1 0/324 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Patient was being treated for MS with SoluMedrol. Adverse event unrelated to smoking study.
[2]
Unable to locate specific adverse reaction/note from cardiology.Patient dropped from the study 2 weeks after being decreased to 2 -14 mg patches per day & previously had quit smoking.
A limitation of this study is the low completion rate of smokers enrolling in the study. This increases the chance of accepting the null hypothesis when there may be differences between groups if all smokers had provided their outcomes.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Geoffrey Williams
Organization: University of Rochester
Phone: 585-530-2050
EMail: geoffrey_williams@urmc.rochester.edu
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Geoffrey C Williams, University of Rochester, Smokers' Health Project
ClinicalTrials.gov Identifier: NCT00178685    
Other Study ID Numbers: 10085
R01 CA10666
1R21CA119112-01A2 ( U.S. NIH Grant/Contract )
First Submitted: September 13, 2005
First Posted: September 15, 2005
Results First Submitted: January 15, 2013
Results First Posted: February 15, 2013
Last Update Posted: February 15, 2013