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| ID | Type | Description | Link |
|---|---|---|---|
| P01CA217806 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This clinical trial collects data to see how filter ventilation and ventilation information affects product use behaviors in cigarette smokers. Providing ventilation information on the cigarette package may affect smokers' rating of product appeal, perceptions of health risk, and changes in cigarette consumption.
PRIMARY OBJECTIVE:
I. To assess how adding messaging to cigarette packages about filter vents and filters influences respondents awareness of filter ventilation, beliefs about the function of filter vents and filters, smoking behavior, ratings of cigarette satisfaction, smoking topography, exposure to nicotine and carbon monoxide, perceptions about the risk of smoking, and intention to stop smoking.
OUTLINE: Participants are randomized to 1 of 4 conditions.
CONDITION I: Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
CONDITION II: Participants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
CONDITION III: Participants receive cigarettes with compensation message "This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
CONDITION IV: Participants receive cigarettes with blocking message "This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Condition 1 (normal cigarettes) | Active Comparator | Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. |
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| Condition II (cigarettes with neutral message) | Experimental | Participants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. |
|
| Condition III (cigarettes with compensation message) | Experimental | Participants receive cigarettes with compensation message "This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection |
|
| Condition IV cigarettes with blocking message | Experimental | Participants receive cigarettes with blocking message "This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cigarette packaging | Other | receive normal packet cigarette |
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| Measure | Description | Time Frame |
|---|---|---|
| Subjective Questionnaires of Product Evaluation | Will be assessed by Duke Sensory Scale. A 9 item questionnaire with nine items that assess participants' sensory experience All questions are rated on a 7-point Likert scale (with 1 meaning -not at all to 7 - meaning extremely). | At 2 weeks |
| Readiness to Quit | Will be assessed by contemplation ladder. This is a 0 to 10 scale, where 0 indicates no willingness/readiness to quit and 10 indicates willing/ready to quit immediately. | At 2 weeks |
| Withdrawal | Will be assessed by Minnesota Tobacco Withdrawal Scale - a 15 item question scale - with scale of 0 -4, 0=Not at all - 4=Severe. A total score is obtained by summing all 15 items. | At 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Level of Exhaled Carbon Monoxide (CO) | level of CO measured in exhaled breath after a 15 seconds breathhold | At 2 weeks |
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Inclusion Criteria:
Aged 21-69 years old
Currently smoking daily, at least 5 cigarettes per day, for the past year:
* Primarily using factory-made filtered cigarettes
Fair and above self-rated physical health (self-rated)
Fair and above self-rated mental health (self-rated)
Not planning to quit smoking in the next 30 days
Able to converse, read, and write in English
Access to smartphone (e.g., iPhone, Android) for Ecological Momentary Assessment (EMA) component
Access to a smartphone/tablet/computer with video capabilities and internet access for remote videoconferencing (EMA check-ins)
Not pregnant or breastfeeding or planning to become pregnant during the study period
Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
Exclusion Criteria:
Age < 21 or > 69
Using roll-your-own cigarettes or usual brand of cigarettes is unfiltered
Planning to quit smoking in the next 30 days
Adults unable to consent
Minors (any persons under age 21)
Prisoners
Poor physical health by self-report
Poor mental health by self-report:
* Exclude Dx psychosis, Dx bipolar, K6 score indicating serious psychological distress
Other illegal drug use in past month
Pregnant or breastfeeding by self-report
No access to smartphone or videoconferencing
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| Name | Affiliation | Role |
|---|---|---|
| Richard O'Connor | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Comprehensive Cancer Center | Buffalo | New York | 14263 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Condition 1 (Normal Cigarettes) | Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies |
| FG001 | Condition II (Cigarettes With Neutral Message) | Participants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies |
| FG002 | Condition III (Cigarettes With Compensation Message) | Participants receive cigarettes with compensation message "This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies |
| FG003 | Condition IV Cigarettes With Blocking Message | Participants receive cigarettes with blocking message "This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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There were 5 patients that withdrew prior to any study assessments and no data were recorded.
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| ID | Title | Description |
|---|---|---|
| BG000 | Condition 1 (Normal Cigarettes) | Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies |
| 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 | Subjective Questionnaires of Product Evaluation | Will be assessed by Duke Sensory Scale. A 9 item questionnaire with nine items that assess participants' sensory experience All questions are rated on a 7-point Likert scale (with 1 meaning -not at all to 7 - meaning extremely). | Posted | Mean | Full Range | units on a scale | At 2 weeks |
|
2 weeks after study enrollment.
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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 | Condition 1 (Normal Cigarettes) | Participants receive regular package cigarettes for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kris Attwood | Roswell Park Comprehensive Cancer Center | 877-275-7724 | askroswell@roswellpark.org |
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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 20, 2021 | Nov 22, 2023 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 8, 2022 | Oct 27, 2022 | ICF_001.pdf |
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| Data capture | Other | Attend video sessions |
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| Questionnaire administration | Other | Ancillary studies |
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| BG001 |
| Condition II (Cigarettes With Neutral Message) |
Participants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies |
| BG002 | Condition III (Cigarettes With Compensation Message) | Participants receive cigarettes with compensation message "This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies |
| BG003 | Condition IV Cigarettes With Blocking Message | Participants receive cigarettes with blocking message "This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Participants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies |
| OG002 | Condition III (Cigarettes With Compensation Message) | Participants receive cigarettes with compensation message "This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies |
| OG003 | Condition IV Cigarettes With Blocking Message | Participants receive cigarettes with blocking message "This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies |
|
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| Primary | Readiness to Quit | Will be assessed by contemplation ladder. This is a 0 to 10 scale, where 0 indicates no willingness/readiness to quit and 10 indicates willing/ready to quit immediately. | Posted | Mean | Full Range | score on a scale | At 2 weeks |
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|
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| Primary | Withdrawal | Will be assessed by Minnesota Tobacco Withdrawal Scale - a 15 item question scale - with scale of 0 -4, 0=Not at all - 4=Severe. A total score is obtained by summing all 15 items. | Posted | Mean | Full Range | score on a scale | At 2 weeks |
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|
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| Secondary | Level of Exhaled Carbon Monoxide (CO) | level of CO measured in exhaled breath after a 15 seconds breathhold | This outcome data was only measured on a random subset of participants. | Posted | Mean | Standard Deviation | parts per million | At 2 weeks |
|
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|
| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Condition II (Cigarettes With Neutral Message) | Participants receive cigarettes with neutral message "Nothing about this product's color or name means that it will protect a smoker from the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection. Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies | 0 | 28 | 0 | 28 | 0 | 28 |
| EG002 | Condition III (Cigarettes With Compensation Message) | Participants receive cigarettes with compensation message "This product has a ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing, which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies | 0 | 31 | 0 | 31 | 0 | 31 |
| EG003 | Condition IV Cigarettes With Blocking Message | Participants receive cigarettes with blocking message "This product has a ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data collection Cigarette packaging: receive normal packet cigarette Data capture: Attend video sessions Questionnaire administration: Ancillary studies | 0 | 21 | 0 | 21 | 0 | 21 |
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| Male |
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