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Promoting Smoking Cessation in Carpenters

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ClinicalTrials.gov Identifier: NCT01878214
Recruitment Status : Completed
First Posted : June 14, 2013
Results First Posted : December 4, 2014
Last Update Posted : December 4, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Washington University School of Medicine

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Smoking Cessation
Health Behavior
Cancer
Interventions Behavioral: Targeted messaging
Behavioral: Standard messaging
Enrollment 442
Recruitment Details We invited 1937 union members to participate; 1638 members completed the baseline survey (84.6%). Of those, 553 were current smokers, 1066 were non-smokers, and the smoking status was unknown for 19 individuals. The smoking rate was 33.8%, slightly lower than expected based on previous studies in this population.
Pre-assignment Details Of 553 current smokers, 111 were not eligible for study inclusion because they either did not sign a consent form (n=49), were not eligible for union benefits (n=57), or had too much data missing at baseline (n=5). The 442 eligible smokers were separated into the four segments and then randomized into the intervention group or the control group.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description

Targeted messaging

Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages

Standard messaging: 1 informational letter

Standard messaging

Standard messaging: 1 informational letter

Period Title: Overall Study
Started 223 219
Completed 170 175
Not Completed 53 44
Reason Not Completed
Withdrawal by Subject             18             7
Death             0             1
Lost to Follow-up             35             36
Arm/Group Title Intervention Group Control Group Total
Hide Arm/Group Description

Targeted messaging

Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages

Standard messaging: 1 informational letter

Standard messaging

Standard messaging: 1 informational letter

Total of all reporting groups
Overall Number of Baseline Participants 223 219 442
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 223 participants 219 participants 442 participants
35.64  (11.54) 35.18  (11.54) 35.33  (11.44)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 219 participants 442 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
221
  99.1%
218
  99.5%
439
  99.3%
>=65 years
2
   0.9%
1
   0.5%
3
   0.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 223 participants 219 participants 442 participants
Female
3
   1.3%
1
   0.5%
4
   0.9%
Male
220
  98.7%
218
  99.5%
438
  99.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 223 participants 219 participants 442 participants
223 219 442
1.Primary Outcome
Title Enrollment in Smoking Cessation Program
Hide Description Enrollment records from the union-sponsored smoking cessation program
Time Frame up to 12 months after recruitment
Hide Outcome Measure Data
Hide Analysis Population Description
Includes all study subjects
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Targeted messaging

Targeted messaging: 6 targeted mailed messages and 6 booster text messages

Standard messaging: 1 informational letter

Standard messaging

Standard messaging: 1 informational letter

Overall Number of Participants Analyzed 223 219
Measure Type: Number
Unit of Measure: participants
5 4
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.76
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Quit Smoking
Hide Description At follow-up, subjects will report current smoking status. ("Do you currently smoke (have you smoked in the last 30 days)?" [Yes, I smoked within the past 30 days; No, but I have smoked in the past 6 months; No, and I have not smoked in more than 6 months]). We will report the % of subjects who have not smoked in the last 30 days and will compare the intervention group with the control group.
Time Frame 7 months after baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey.
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Targeted messaging

Targeted messaging: 6 targeted mailed messages and 6 booster text messages

Standard messaging: 1 informational letter

Standard messaging

Standard messaging: 1 informational letter

Overall Number of Participants Analyzed 170 175
Measure Type: Number
Unit of Measure: percentage of participants
17.1 16.0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
3.Secondary Outcome
Title Changes in Smoking Behaviors (Frequency and Quantity)
Hide Description At baseline and follow-up, subjects will report smoking frequency ("How often do you smoke?" [everyday, at least 4 days/week, 1-3 days/week, less than one day/week]) and quantity ("On days that you smoke, how many cigarettes do you have per day?" [10 or less, 11-20, 21-30, 31 or more]). We will report the % of subjects who smoke less frequently and smoke fewer cigarettes per day at follow-up compared to baseline. We will compare the intervention group with the control group.
Time Frame 7 months after recruitment
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Targeted messaging

Targeted messaging: 6 targeted mailed messages and 6 booster text messages

Standard messaging: 1 informational letter

Standard messaging

Standard messaging: 1 informational letter

Overall Number of Participants Analyzed 141 147
Measure Type: Number
Unit of Measure: percentage of participants
Smoked less frequently 14.8 12.2
Smoked fewer cigarettes per day 24.8 19.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments Smoking frequency
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments Smoking quantity
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.30
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
4.Secondary Outcome
Title Changes in Readiness to Quit Smoking in the Next 6 Months
Hide Description Subjects will answer the following question at both baseline and follow-up surveys: "Are you seriously considering quitting smoking in the next 6 months?" [yes/no]. We will report % of subjects who said "no" at baseline and "yes" at follow-up to determine changes in readiness to quit smoking and compare between intervention and control groups.
Time Frame 7 months after recruitment
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Targeted messaging

Targeted messaging: 6 targeted mailed messages and 6 booster text messages

Standard messaging: 1 informational letter

Standard messaging

Standard messaging: 1 informational letter

Overall Number of Participants Analyzed 141 147
Measure Type: Number
Unit of Measure: percentage of participants
9.2 13.6
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.28
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
5.Secondary Outcome
Title Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking
Hide Description At baseline and follow-up, subjects will answer questions about motivation to quit smoking ("How motivated are you to quit smoking at this time? [scale: 1 (not at all) - 10 (extremely)]) and thinking about quitting smoking ("Each rung on this ladder represents where various smokers are in their thinking about quitting. Circle the number that indicates where you are now. [0 (no thoughts of quitting) -10 (taking action to quit)]). We will report the % of subjects who reported more motivation to quit and greater thinking about quitting at follow-up compared to baseline. We will compare the intervention group with the control group.
Time Frame 7 months after recruitment
Hide Outcome Measure Data
Hide Analysis Population Description
Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. This outcome was only measured in those who reported smoking in the last 30 days (n=288, 83.5%).
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description:

Targeted messaging

Targeted messaging: 6 targeted mailed messages and 6 booster text messages

Standard messaging: 1 informational letter

Standard messaging

Standard messaging: 1 informational letter

Overall Number of Participants Analyzed 141 147
Measure Type: Number
Unit of Measure: percentage of participants
More motivated to quit smoking 14.9 23.8
Greater thinking about quitting smoking 12.1 22.5
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments Motivation to quit
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.09
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Intervention Group, Control Group
Comments Thinking about quitting
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Time Frame 7 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Intervention Group Control Group
Hide Arm/Group Description

Targeted messaging

Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages

Standard messaging: 1 informational letter

Standard messaging

Standard messaging: 1 informational letter

All-Cause Mortality
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/223 (0.00%)   0/219 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Intervention Group Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   0/223 (0.00%)   0/219 (0.00%) 
Messages were based on feedback from a small sample that over-represented young workers; messages may not have been applicable to all union members. Intervention reach was low; only 42% of intervention participants reporting receiving postcards.
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: Jaime Strickland, MA
Organization: Washington University School of Medicine in St. Louis
Phone: 314-454-7337
EMail: jstrickl@dom.wustl.edu
Publications:
Layout table for additonal information
Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT01878214     History of Changes
Other Study ID Numbers: 201110075
R21CA161169 ( U.S. NIH Grant/Contract )
First Submitted: May 22, 2013
First Posted: June 14, 2013
Results First Submitted: November 25, 2014
Results First Posted: December 4, 2014
Last Update Posted: December 4, 2014