Cancer, Health Behavior, Smoking Cessation
Conditions
Keywords
Health communication, Smoking cessation, Health behavior, Construction industry, Audience segmentation
Brief summary
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.
Detailed description
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. * Control subjects will receive one standard mailing informing them about the free smoking cessation program available to union members. * Intervention subjects will receive the standard mailing in addition to six targeted smoking cessation messages delivered monthly by mail to their homes. Messages will be specific to one of four audience segments determined by age and parental status. In addition to a segment-specific anti-smoking message, each mailing will have contact information for the union smoking cessation program. Intervention subjects who consented to text messaging will also receive one booster text message each month with a shortened targeted message.
Interventions
BEHAVIORALTargeted messaging
6 targeted mailed messages and 6 booster text messages
BEHAVIORALStandard messaging
1 informational letter
Sponsors
National Cancer Institute (NCI)
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Current smoker (smoked cigarettes within the last 30 days) * Eligible for union health benefits
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment in Smoking Cessation Program | up to 12 months after recruitment | Enrollment records from the union-sponsored smoking cessation program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quit Smoking | 7 months after baseline | 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. |
| Changes in Smoking Behaviors (Frequency and Quantity) | 7 months after recruitment | 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. |
| Changes in Readiness to Quit Smoking in the Next 6 Months | 7 months after recruitment | 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. |
| Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking | 7 months after recruitment | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Group Targeted messaging
Targeted messaging: 1 informational letter plus 6 targeted mailed messages and 6 booster text messages
Standard messaging: 1 informational letter | 223 |
| Control Group Standard messaging
Standard messaging: 1 informational letter | 219 |
| Total | 442 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 35 | 36 |
| Overall Study | Withdrawal by Subject | 18 | 7 |
Baseline characteristics
| Characteristic | Intervention Group | Control Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 221 Participants | 218 Participants | 439 Participants |
| Age, Continuous | 35.64 years STANDARD_DEVIATION 11.54 | 35.18 years STANDARD_DEVIATION 11.54 | 35.33 years STANDARD_DEVIATION 11.44 |
| Region of Enrollment United States | 223 participants | 219 participants | 442 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 4 Participants |
| Sex: Female, Male Male | 220 Participants | 218 Participants | 438 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 223 | 0 / 219 |
| serious Total, serious adverse events | 0 / 223 | 0 / 219 |
Outcome results
Primary
Enrollment in Smoking Cessation Program
Enrollment records from the union-sponsored smoking cessation program
Time frame: up to 12 months after recruitment
Population: Includes all study subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Enrollment in Smoking Cessation Program | 5 participants |
| Control Group | Enrollment in Smoking Cessation Program | 4 participants |
p-value: 0.76Chi-squared
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.
Time frame: 7 months after recruitment
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking | More motivated to quit smoking | 14.9 percentage of participants |
| Intervention Group | Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking | Greater thinking about quitting smoking | 12.1 percentage of participants |
| Control Group | Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking | More motivated to quit smoking | 23.8 percentage of participants |
| Control Group | Changes in Motivation to Quit Smoking and Thinking About Quitting Smoking | Greater thinking about quitting smoking | 22.5 percentage of participants |
Comparison: Motivation to quitp-value: 0.09Regression, Logistic
Comparison: Thinking about quittingp-value: 0.04Regression, Logistic
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.
Time frame: 7 months after recruitment
Population: 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 | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Changes in Readiness to Quit Smoking in the Next 6 Months | 9.2 percentage of participants |
| Control Group | Changes in Readiness to Quit Smoking in the Next 6 Months | 13.6 percentage of participants |
p-value: 0.28Regression, Logistic
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.
Time frame: 7 months after recruitment
Population: 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 | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intervention Group | Changes in Smoking Behaviors (Frequency and Quantity) | Smoked less frequently | 14.8 percentage of participants |
| Intervention Group | Changes in Smoking Behaviors (Frequency and Quantity) | Smoked fewer cigarettes per day | 24.8 percentage of participants |
| Control Group | Changes in Smoking Behaviors (Frequency and Quantity) | Smoked less frequently | 12.2 percentage of participants |
| Control Group | Changes in Smoking Behaviors (Frequency and Quantity) | Smoked fewer cigarettes per day | 19.7 percentage of participants |
Comparison: Smoking frequencyp-value: 0.63Regression, Logistic
Comparison: Smoking quantityp-value: 0.3Regression, Logistic
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.
Time frame: 7 months after baseline
Population: Secondary outcomes were collected via self-report survey approximately 7 months after study enrollment; 345 subjects (78%) completed the follow-up survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Intervention Group | Quit Smoking | 17.1 percentage of participants |
| Control Group | Quit Smoking | 16.0 percentage of participants |
p-value: 0.79Regression, Logistic