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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA161169 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The purpose of this study is to test an innovative and sustainable intervention to increase participation in a union-sponsored smoking cessation program among carpenters and floor layers. The investigators will conduct a randomized controlled trial comparing targeted messaging versus standard messaging. All subjects will receive information about the free, union-sponsored smoking cessation program. Subjects randomized to the intervention group will receive additional targeted materials to encourage enrollment in the union's smoking cessation program. The intervention will include monthly mailed and text messages. The investigators hypothesize that subjects who receive targeted messages will be more likely to enroll in the union-sponsored smoking cessation program, be more likely to show change in readiness to quit smoking, and be more likely to quit smoking compared to subjects who receive only standard messaging.
Specific Aim 1: Develop targeted health messages based on audience segmentation to encourage smokers to enroll in a comprehensive union-sponsored smoking cessation program.
We will craft six specific health messages that appeal to four different audience segments: workers under 30 years old without children, workers under 30 with children, workers 30 years old or older without children, and workers 30 or older with children.
Specific Aim 2: Conduct a randomized controlled trial of targeted messaging based on audience segmentation versus standard smoking cessation messaging.
After conducting baseline surveys with union carpenters and floor layers, we will randomize current smokers (smoked within the last 30 days) into either the intervention or control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Targeted messaging |
|
| Control group | Active Comparator | Standard messaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Targeted messaging | Behavioral | 6 targeted mailed messages and 6 booster text messages |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment in Smoking Cessation Program | Enrollment records from the union-sponsored smoking cessation program | up to 12 months after recruitment |
| Measure | Description | Time Frame |
|---|---|---|
| Quit Smoking | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bradley Evanoff, MD, MPH | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14759942 | Background | Barbeau EM, Krieger N, Soobader MJ. Working class matters: socioeconomic disadvantage, race/ethnicity, gender, and smoking in NHIS 2000. Am J Public Health. 2004 Feb;94(2):269-78. doi: 10.2105/ajph.94.2.269. | |
| 16411053 | Background | Barbeau EM, Li Y, Calderon P, Hartman C, Quinn M, Markkanen P, Roelofs C, Frazier L, Levenstein C. Results of a union-based smoking cessation intervention for apprentice iron workers (United States). Cancer Causes Control. 2006 Feb;17(1):53-61. doi: 10.1007/s10552-005-0271-0. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Group | Targeted messaging Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages Standard messaging: 1 informational letter |
| FG001 | Control Group | Standard messaging Standard messaging: 1 informational letter |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention Group | Targeted messaging Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages Standard messaging: 1 informational letter |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Enrollment in Smoking Cessation Program | Enrollment records from the union-sponsored smoking cessation program | Includes all study subjects | Posted | Number | participants | up to 12 months after recruitment |
|
7 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention Group | Targeted messaging Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages Standard messaging: 1 informational letter |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jaime Strickland, MA | Washington University School of Medicine in St. Louis | 314-454-7337 | jstrickl@dom.wustl.edu |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| D015438 | Health Behavior |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
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| Standard messaging | Behavioral | 1 informational letter |
|
| 7 months after baseline |
| Changes in Smoking Behaviors (Frequency and Quantity) | 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. | 7 months after recruitment |
| Changes in Readiness to Quit Smoking in the Next 6 Months | 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. | 7 months after recruitment |
| Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking | 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. | 7 months after recruitment |
| 15203794 | Background | Bock B, Graham A, Sciamanna C, Krishnamoorthy J, Whiteley J, Carmona-Barros R, Niaura R, Abrams D. Smoking cessation treatment on the Internet: content, quality, and usability. Nicotine Tob Res. 2004 Apr;6(2):207-19. doi: 10.1080/14622200410001676332. |
| 2030191 | 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. |
| 2668531 | Background | Fagerstrom KO, Schneider NG. Measuring nicotine dependence: a review of the Fagerstrom Tolerance Questionnaire. J Behav Med. 1989 Apr;12(2):159-82. doi: 10.1007/BF00846549. |
| 19135907 | Background | Fjeldsoe BS, Marshall AL, Miller YD. Behavior change interventions delivered by mobile telephone short-message service. Am J Prev Med. 2009 Feb;36(2):165-73. doi: 10.1016/j.amepre.2008.09.040. |
| 21988795 | Background | Ham DC, Przybeck T, Strickland JR, Luke DA, Bierut LJ, Evanoff BA. Occupation and workplace policies predict smoking behaviors: analysis of national data from the current population survey. J Occup Environ Med. 2011 Nov;53(11):1337-45. doi: 10.1097/JOM.0b013e3182337778. |
| 14672383 | Background | Kreuter MW, Wray RJ. Tailored and targeted health communication: strategies for enhancing information relevance. Am J Health Behav. 2003 Nov-Dec;27 Suppl 3:S227-32. doi: 10.5993/ajhb.27.1.s3.6. |
| 17215716 | Background | Lee DJ, Fleming LE, Arheart KL, LeBlanc WG, Caban AJ, Chung-Bridges K, Christ SL, McCollister KE, Pitman T. Smoking rate trends in U.S. occupational groups: the 1987 to 2004 National Health Interview Survey. J Occup Environ Med. 2007 Jan;49(1):75-81. doi: 10.1097/JOM.0b013e31802ec68c. |
| 22011991 | Background | Maibach EW, Maxfield A, Ladin K, Slater M. Translating health psychology into effective health communication: the american healthstyles audience segmentation project. J Health Psychol. 1996 Jul;1(3):261-77. doi: 10.1177/135910539600100302. |
| 10495586 | Background | Nigg CR, Burbank PM, Padula C, Dufresne R, Rossi JS, Velicer WF, Laforge RG, Prochaska JO. Stages of change across ten health risk behaviors for older adults. Gerontologist. 1999 Aug;39(4):473-82. doi: 10.1093/geront/39.4.473. |
| 19301135 | Background | Okechukwu CA, Krieger N, Sorensen G, Li Y, Barbeau EM. MassBuilt: effectiveness of an apprenticeship site-based smoking cessation intervention for unionized building trades workers. Cancer Causes Control. 2009 Aug;20(6):887-94. doi: 10.1007/s10552-009-9324-0. Epub 2009 Mar 20. |
| 21474634 | Background | Okechukwu CA, Krieger N, Sorensen G, Li Y, Barbeau EM. Testing hypothesized psychosocial mediators: lessons learned in the MassBUILT study. Health Educ Behav. 2011 Aug;38(4):404-11. doi: 10.1177/1090198110380544. Epub 2011 Apr 7. |
| 16117232 | Background | Perry RJ, Keller PA, Fraser D, Fiore MC. Fax to quit: a model for delivery of tobacco cessation services to Wisconsin residents. WMJ. 2005 May;104(4):37-40, 44. |
| 12382249 | Background | Ringen K, Anderson N, McAfee T, Zbikowski SM, Fales D. Smoking cessation in a blue-collar population: results from an evidence-based pilot program. Am J Ind Med. 2002 Nov;42(5):367-77. doi: 10.1002/ajim.10129. |
| 10947364 | Background | Slater MD. Theory and method in health audience segmentation. J Health Commun. 1996 Jul-Sep;1(3):267-83. doi: 10.1080/108107396128059. |
| 18270453 | Background | Smith DR. Tobacco smoking by occupation in Australia and the United States: a review of national surveys conducted between 1970 and 2005. Ind Health. 2008 Jan;46(1):77-89. doi: 10.2486/indhealth.46.77. |
| 12914824 | Background | Sorensen G, Emmons K, Hunt MK, Barbeau E, Goldman R, Peterson K, Kuntz K, Stoddard A, Berkman L. Model for incorporating social context in health behavior interventions: applications for cancer prevention for working-class, multiethnic populations. Prev Med. 2003 Sep;37(3):188-97. doi: 10.1016/s0091-7435(03)00111-7. |
| 14759932 | Background | Sorensen G, Barbeau E, Hunt MK, Emmons K. Reducing social disparities in tobacco use: a social-contextual model for reducing tobacco use among blue-collar workers. Am J Public Health. 2004 Feb;94(2):230-9. doi: 10.2105/ajph.94.2.230. |
| 17186421 | Background | Sorensen G, Barbeau EM, Stoddard AM, Hunt MK, Goldman R, Smith A, Brennan AA, Wallace L. Tools for health: the efficacy of a tailored intervention targeted for construction laborers. Cancer Causes Control. 2007 Feb;18(1):51-9. doi: 10.1007/s10552-006-0076-9. |
| 3998990 | Background | Velicer WF, DiClemente CC, Prochaska JO, Brandenburg N. Decisional balance measure for assessing and predicting smoking status. J Pers Soc Psychol. 1985 May;48(5):1279-89. doi: 10.1037//0022-3514.48.5.1279. |
| 16461418 | Background | Vladutiu CJ, Nansel TR, Weaver NL, Jacobsen HA, Kreuter MW. Differential strength of association of child injury prevention attitudes and beliefs on practices: a case for audience segmentation. Inj Prev. 2006 Feb;12(1):35-40. doi: 10.1136/ip.2004.007153. |
| Lost to Follow-up |
|
Standard messaging
Standard messaging: 1 informational letter
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Categorical | Count of Participants | Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | Quit Smoking | 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. | Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey. | Posted | Number | percentage of participants | 7 months after baseline |
|
|
|
|
| Secondary | Changes in Smoking Behaviors (Frequency and Quantity) | 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. | 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%). | Posted | Number | percentage of participants | 7 months after recruitment |
|
|
|
|
| Secondary | Changes in Readiness to Quit Smoking in the Next 6 Months | 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. | 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%). | Posted | Number | percentage of participants | 7 months after recruitment |
|
|
|
|
| Secondary | Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking | 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. | 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%). | Posted | Number | percentage of participants | 7 months after recruitment |
|
|
|
|
| 0 |
| 223 |
| 0 |
| 223 |
| EG001 | Control Group | Standard messaging Standard messaging: 1 informational letter | 0 | 219 | 0 | 219 |
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| 0.30 |
| 2-Sided |
| No |
| Superiority or Other |
| 0.04 |
| 2-Sided |
| No |
| Superiority or Other |