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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-02543 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| K99CA260718 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial refines and evaluates anti-tobacco messages among lesbian, gay, bisexual, and transgender (LGBT) young adults at risk for the use of more than one tobacco product (polytobacco use). Polytobacco use is associated with nicotine dependence and tobacco use into adulthood, and is disproportionately high among LGBT young adults. This trial seeks to determine effective communication of polytobacco use risk to at-risk LGBT young adults.
PRIMARY OBJECTIVES:
I. Identify absolute and relative risk anti-tobacco messages that effectively communicate polytobacco risks to lesbian, gay, bisexual, transgender (LGBT) young adults.
Participants view anti-tobacco messages and rate them for perceived effectiveness and reactance.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AR-Quit | Experimental | Participants view messages with absolute risk and quit statements |
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| AR-Switch | Experimental | Participants view messages with absolute risk and switch statements |
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| AR-Combination | Experimental | Participants view messages with absolute risk and combination quit+switch statements |
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| RR-Quit | Experimental | Participants view messages with comparative risk and quit statements |
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| RR-Switch | Experimental | Participants view messages with comparative risk and switch statements |
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| RR-Combination | Experimental | Participants view messages with comparative risk and combination quit+switch statements |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health communications | Other | Participants are assigned to view health communications with risk and efficacy statements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Message Perceived Effectiveness - Persuasive Potential. | 6 items measured on 5-point scale, 1 = Not at all and 5 = Very much
Responses were summed and averaged to create a scale for intention to quit (range from 1 - 5). Higher scores indicate a higher persuasive potential of the message. | Immediately post-exposure to intervention, up to 1 hour |
| Perceived Effectiveness - Perceived Behavioral Impact | Six items were analyzed separately, each scored on 5-point Likert scale (1=Strongly Disagree, 5=Strongly Agree) These messages will motivate CIGARETTE SMOKERS to switch to vaping. These messages will motivate people to quit ALL smoking and vaping. These messages will motivate NON-USERS to start vaping. These messages will motivate NON-USERS to start smoking cigarettes. These messages will motivate CIGARETTE SMOKERS to quit. These messages will motivate VAPERS to quit. | Immediately post-exposure to intervention, up to 1 hour |
| Risk Perceptions: Absolute/Relative Risks of Cigarette vs. E-cigarette Use | On a scale from 0-10, where 0 = not at all harmful and 10 = extremely harmful now harmful are ... to your health?
On a scale from 0-10, where 0 = much less harmful and 10 = much more harmful... • compared to combustible cigarettes, how harmful are nicotine vapes to your health? | Immediately post-exposure to intervention, up to 1 hour |
| Behavioral Intentions to Use Tobacco | 8-items made up two 4-pt scales (1 = definitely will not and 4 = definitely will). Items for each scale were summed and averaged. Higher scores indicate higher likelihood of avoiding cigarettes/nicotine vapes. How likely it is that in the next 3 months, you will refrain from...
How likely it is that in the next 3 months, you will refrain from...
|
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Inclusion Criteria:
At least 50% of the sample also:
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| Name | Affiliation | Role |
|---|---|---|
| Joanne G Patterson, PhD MPH MSW | Ohio State University Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | United States |
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| Label | URL |
|---|---|
| The Jamesline | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | AR-Quit | Participants view messages with absolute risk and quit statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| FG001 | AR-Switch | Participants view messages with absolute risk and switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| FG002 | AR-Combination | Participants view messages with absolute risk and combination quit+switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| FG003 | RR-Quit | Participants view messages with comparative risk and quit statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| FG004 | RR-Switch | Participants view messages with comparative risk and switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| FG005 | RR-Combination | Participants view messages with comparative risk and combination quit+switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| FG006 | Control | Participants view FDA regulatory messages Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AR-Quit | Participants view messages with absolute risk and quit statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| BG001 | AR-Switch |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| 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 | Message Perceived Effectiveness - Persuasive Potential. | 6 items measured on 5-point scale, 1 = Not at all and 5 = Very much
Responses were summed and averaged to create a scale for intention to quit (range from 1 - 5). Higher scores indicate a higher persuasive potential of the message. | Analytic population only included participants who had no missing data for any scale items. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately post-exposure to intervention, up to 1 hour |
|
1 hour post-baseline
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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 | AR-Quit | Participants view messages with absolute risk and quit statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joanne G. Patterson | The Ohio State University College of Public Health | 614-247-1780 | patterson.1191@osu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 22, 2022 | Nov 13, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D058015 | Health Communication |
| ID | Term |
|---|---|
| D005159 | Health Care Facilities Workforce and Services |
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| Control | Other | Participants view FDA regulatory messages |
|
| Immediately post-exposure to intervention, up to 1 hour |
Participants view messages with absolute risk and switch statements
Health communications: Participants are assigned to view health communications with risk and efficacy statements.
| BG002 | AR-Combination | Participants view messages with absolute risk and combination quit+switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| BG003 | RR-Quit | Participants view messages with comparative risk and quit statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| BG004 | RR-Switch | Participants view messages with comparative risk and switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| BG005 | RR-Combination | Participants view messages with comparative risk and combination quit+switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| BG006 | Control | Participants view FDA regulatory messages Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Sexual Orientation | Count of Participants | Participants |
|
| Smoking status | Participants self-identified as currently using combustible cigarettes (use within the past 30-days), formerly using cigarettes (used at least once in lifetime, but not within past 30-days), and never using cigarettes. | Count of Participants | Participants |
|
| Vaping status | Participants self-identified as currently using nicotine vapes (use within the past 30-days), formerly using nicotine vapes (used at least once in lifetime, but not within past 30-days), and never using nicotine vapes. | Count of Participants | Participants |
|
| Dual smoking/vaping status | Participants self-identified as currently using both combustible cigarettes and nicotine vapes (use within the past 30-days), formerly using both cigarettes and nicotine vapes (used at least once in lifetime, but not within past 30-days), currently using cigarettes OR nicotine vapes (not both), or never using either cigarettes or nicotine vapes. | Count of Participants | Participants |
|
| OG001 | AR-Switch | Participants view messages with absolute risk and switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| OG002 | AR-Combination | Participants view messages with absolute risk and combination quit+switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| OG003 | RR-Quit | Participants view messages with comparative risk and quit statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| OG004 | RR-Switch | Participants view messages with comparative risk and switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| OG005 | RR-Combination | Participants view messages with comparative risk and combination quit+switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
| OG006 | Control | Participants view FDA regulatory messages Health communications: Participants are assigned to view health communications with risk and efficacy statements. |
|
|
| Primary | Perceived Effectiveness - Perceived Behavioral Impact | Six items were analyzed separately, each scored on 5-point Likert scale (1=Strongly Disagree, 5=Strongly Agree) These messages will motivate CIGARETTE SMOKERS to switch to vaping. These messages will motivate people to quit ALL smoking and vaping. These messages will motivate NON-USERS to start vaping. These messages will motivate NON-USERS to start smoking cigarettes. These messages will motivate CIGARETTE SMOKERS to quit. These messages will motivate VAPERS to quit. | Analytic population did not include participants with missing data for outcomes. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately post-exposure to intervention, up to 1 hour |
|
|
|
| Primary | Risk Perceptions: Absolute/Relative Risks of Cigarette vs. E-cigarette Use | On a scale from 0-10, where 0 = not at all harmful and 10 = extremely harmful now harmful are ... to your health?
On a scale from 0-10, where 0 = much less harmful and 10 = much more harmful... • compared to combustible cigarettes, how harmful are nicotine vapes to your health? | Analytic population included participants with no missing data on outcomes. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately post-exposure to intervention, up to 1 hour |
|
|
|
| Primary | Behavioral Intentions to Use Tobacco | 8-items made up two 4-pt scales (1 = definitely will not and 4 = definitely will). Items for each scale were summed and averaged. Higher scores indicate higher likelihood of avoiding cigarettes/nicotine vapes. How likely it is that in the next 3 months, you will refrain from...
How likely it is that in the next 3 months, you will refrain from...
| Analytic population included participants who did not have missing data on outcomes. | Posted | Mean | 95% Confidence Interval | units on a scale | Immediately post-exposure to intervention, up to 1 hour |
|
|
|
| 0 |
| 407 |
| 0 |
| 407 |
| 0 |
| 407 |
| EG001 | AR-Switch | Participants view messages with absolute risk and switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. | 0 | 407 | 0 | 407 | 0 | 407 |
| EG002 | AR-Combination | Participants view messages with absolute risk and combination quit+switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. | 0 | 407 | 0 | 407 | 0 | 407 |
| EG003 | RR-Quit | Participants view messages with comparative risk and quit statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. | 0 | 407 | 0 | 407 | 0 | 407 |
| EG004 | RR-Switch | Participants view messages with comparative risk and switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. | 0 | 407 | 0 | 407 | 0 | 407 |
| EG005 | RR-Combination | Participants view messages with comparative risk and combination quit+switch statements Health communications: Participants are assigned to view health communications with risk and efficacy statements. | 0 | 407 | 0 | 407 | 0 | 407 |
| EG006 | Control | Participants view FDA regulatory messages Health communications: Participants are assigned to view health communications with risk and efficacy statements. | 0 | 407 | 0 | 407 | 0 | 407 |
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| These messages will motivate CIGARETTE SMOKERS to quit. |
|
| These messages will motivate CIGARETTE SMOKERS to switch to vaping |
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| These messages will motivate VAPERS to quit. |
|
| These messages will motivate NON-USERS to start vaping. |
|
| These messages will motivate NON-USERS to start smoking cigarettes. |
|
| Absolute harm of nicotine vapes to health |
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| Relative harm of nicotine vapes (vs combustible cigarettes) to health |
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| Behavioral intentions to smoke cigarettes |
|