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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA240732 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Food and Drug Administration (FDA) | FED |
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The goal of this research is to determine how removal of little cigar and cigarillo (LCC) flavor descriptors on packaging impacts attention and affective responses to LCC warnings. A study will be conducted using eye tracking, electrodermal activity (galvanic skin response), and survey measures of affect to measure participant responses to LCC packages varied by warning type (pictorial vs. text only) and flavor contents ('Sweet' flavor descriptor vs. no flavor descriptor).
Over 4 million US adults regularly smoke cigars, which causes multiple cancers, including oral, esophageal, pancreatic, laryngeal, and lung cancer. Even smoking 1-2 cigars per day is associated with elevated cancer risk. Though cigarette consumption decreased 39% from 2000 to 2015, cigar consumption increased 85%. Of the three major types of cigars-large cigars, little cigars, and cigarillos-little cigars and cigarillos (LCC) are the most commonly used in the US. LCC use among adults has increased in part because LCCs are taxed at a lower rate than cigarettes, are subject to fewer regulations and marketing restrictions, can be purchased in small pack sizes, and are exempt from flavor bans that apply to cigarettes.
In May 2016, the Food and Drug Administration (FDA) required text-only warnings on LCC packs, rotating among six statements. Research on cigarettes suggests warnings on packs should have multiple rotating sets, contain images illustrating the negative health effects associated with LCC use, and be large. However, the evidence for cigarette warning labels cannot adequately inform implementation of improved LCC warnings for four reasons: 1) The currently mandated cigar warnings differ from existing cigarette warnings; 2) there is no evidence on the effectiveness of the currently mandated cigar warnings (i.e., behavioral intentions or outcomes) or evidence on efforts that might improve LCC warnings (i.e., images, larger warning size, removal of LCC flavor descriptors on packaging); 3) Courts have ruled that one type of effective tobacco warning (i.e., for cigarettes) cannot be used to justify other types of tobacco warnings, such as those for LCCs and 4) LCC users have different demographic and consumption profiles than cigarette users (i.e., LCC users include a higher proportion of young adults African Americans, and LCCs are used on fewer days per month, which should be taken into account when developing improved warnings.
Gaps exist in understanding how LCC policies, such as the removal of flavor descriptors on packaging, influence the impact of LCC warnings. This eye tracking and psychophysiology project will provide new data to fill these evidence gaps and advance general scientific knowledge about elements of tobacco warnings research.
During the study, Participants will see 12 LCC pack stimuli images presented in random order. 3 packs will feature pictorial LCC warnings and a "Sweet" flavor descriptor, and the same 3 warnings will be presented on packs without a flavor. The remaining 6 LCC packs will have 3 text-only warnings, with 3 images containing the "Sweet" flavor and 3 images without a flavor. We will measure attention to the warnings and attention to the flavor descriptors as well as electrodermal activity and affective responses for each of the 12 stimuli.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants | Other | All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LCC pack stimuli images | Behavioral | All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total). |
| Measure | Description | Time Frame |
|---|---|---|
| Attention to Warning Areas of Interest | Mean attention to warning areas of interest in seconds will be measured by dwell time to pre-defined areas of interest on the LCC packages. The mean amount of time in seconds that participants spend looking at the flavor area of interest for the 3 packages in each condition will be determined. | During one time study appointment |
| Attention to Flavor Areas of Interest | Mean attention to flavor areas of interest in seconds will be measured by dwell time to pre-defined areas of interest on the LCC packages. The mean amount of time in seconds that participants spend looking at the flavor area of interest for the 3 packages in each condition will be determined. | During one time study appointment |
| Measure | Description | Time Frame |
|---|---|---|
| Positive Affect | Mean positive affect response to warnings will be measured using an adaptation of the Discrete Emotions Questionnaire. The positive affect questionnaire will include 6 different emotions to measure participant's emotional responses to the cigarillo packages. Participants will rate to what extent they experienced each emotion while viewing the LCC package on a scale of 1 to 7, where 1=not at all and 7=an extreme amount. Higher affective responses indicate stronger positive emotional reactions to the LCC package. The mean positive affect will reflect the mean positive affect rating for the 3 packages in each condition. |
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Participants will be recruited through flyers, emails, and recruitment websites to identify potentially eligible participants local to our study location (Chapel Hill/Carrboro, NC)
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Adam O Goldstein | UNC Lineberger Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
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| Label | URL |
|---|---|
| University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials | View source |
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90 participants arrived for their study appointment, began the study, and completed the study, which was a one-time appointment. All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total).
Participants were recruited and screened for study eligibility online between July 2024 and March 2025, and invited to in the study once they were determined to be eligible.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All Participants
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total). |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Attention to Warning Areas of Interest | Mean attention to warning areas of interest in seconds will be measured by dwell time to pre-defined areas of interest on the LCC packages. The mean amount of time in seconds that participants spend looking at the flavor area of interest for the 3 packages in each condition will be determined. | All participants, mean response to the 3 package stimuli in each condition were combined consistent with the study hypotheses examining the difference between warning type (text vs. pictorial) and flavor (no flavor vs. "SWEET" flavor). | Posted | Mean | Standard Deviation | seconds | During one time study appointment |
|
During one time study appointment
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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 | All Participants | All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Adam O Goldstein | UNC Lineberger Comprehensive Cancer Center | 919-270-6491 | AOG@med.unc.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 3, 2024 | Mar 9, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 1, 2024 | Mar 9, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| ID | Term |
|---|---|
| D001519 | Behavior |
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All participants saw LCC pack stimuli images presented in random order, 4 package conditions were repeated with 3 warnings applied to each (12 stimuli total).
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| During one time study appointment |
| Negative Affect | Mean negative affect response to warnings will be measured using an adaptation of the Discrete Emotions Questionnaire. The negative affect questionnaire will include 6 different emotions to measure participant's emotional responses to the cigarillo packages. Participants will rate to what extent they experienced each emotion while viewing the LCC package on a scale of 1 to 7, where 1=not at all and 7=an extreme amount. Higher affective responses indicate stronger negative emotional reactions to the LCC package. The mean negative affect will reflect the mean negative affect rating for the 3 packages in each condition. | During one time study appointment |
| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Secondary | Positive Affect | Mean positive affect response to warnings will be measured using an adaptation of the Discrete Emotions Questionnaire. The positive affect questionnaire will include 6 different emotions to measure participant's emotional responses to the cigarillo packages. Participants will rate to what extent they experienced each emotion while viewing the LCC package on a scale of 1 to 7, where 1=not at all and 7=an extreme amount. Higher affective responses indicate stronger positive emotional reactions to the LCC package. The mean positive affect will reflect the mean positive affect rating for the 3 packages in each condition. | All participants, mean response to the 3 package stimuli in each condition were combined consistent with the study hypotheses examining the difference between warning type (text vs. pictorial) and flavor (no flavor vs. "SWEET" flavor). | Posted | Mean | Standard Deviation | units on a scale | During one time study appointment |
|
|
|
| Primary | Attention to Flavor Areas of Interest | Mean attention to flavor areas of interest in seconds will be measured by dwell time to pre-defined areas of interest on the LCC packages. The mean amount of time in seconds that participants spend looking at the flavor area of interest for the 3 packages in each condition will be determined. | All participants, mean response to the 3 package stimuli in each condition were combined consistent with the study hypotheses examining the difference between warning type (text vs. pictorial) and flavor (no flavor vs. "SWEET" flavor). | Posted | Mean | Standard Deviation | seconds | During one time study appointment |
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|
|
| Secondary | Negative Affect | Mean negative affect response to warnings will be measured using an adaptation of the Discrete Emotions Questionnaire. The negative affect questionnaire will include 6 different emotions to measure participant's emotional responses to the cigarillo packages. Participants will rate to what extent they experienced each emotion while viewing the LCC package on a scale of 1 to 7, where 1=not at all and 7=an extreme amount. Higher affective responses indicate stronger negative emotional reactions to the LCC package. The mean negative affect will reflect the mean negative affect rating for the 3 packages in each condition. | All participants, mean response to the 3 package stimuli in each condition were combined consistent with the study hypotheses examining the difference between warning type (text vs. pictorial) and flavor (no flavor vs. "SWEET" flavor). | Posted | Mean | Standard Deviation | units on a scale | During one time study appointment |
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| 0 |
| 90 |
| 0 |
| 90 |
| 0 |
| 90 |
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| Text-only warning and 'sweet' flavor |
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| Text-only warning and 'sweet' flavor |
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| Text-only warning and 'sweet' flavor |
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