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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA207229-06 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This research is a randomized smoking cessation trial conducted within and specifically personalized for lung cancer screening patients presenting to a lung screening clinic. Novel tobacco treatments for this population are critically needed, given the growing population of lung screening patients, which will grow dramatically now that lung screening is an approved CMS benefit. In the proposed study, we will test a gain-framed messaging intervention specifically designed for lung screening patients (vs. unframed messaging), as well as evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be translational (in that it can be transferable from our controlled efficacy study to other lung screening programs).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unframed Messaging | Active Comparator | Unframed smoking cessation materials |
|
| Gain-framed Messaging | Experimental | Gain-framed messaging |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gain-framed messaging | Behavioral | Gain-framed messaging materials |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Smoking Cessation - Available Data | Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit | 6 month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Cigarettes Smoked Per Day - Average | Gain-framed messaging vs. Unframed messaging - average reported cigarettes smoked per day. | 6 month follow-up |
| Smoking Cessation - Imputed | Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit. Missing participant data imputed to no cessation. 3 participants from the unframed group were not included as they had died prior to the 6-month visit. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Benjamin Toll, PhD | Medical University of South Carolina | Principal Investigator |
| Alana Rojewski, PhD | Medical University of South Carolina | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale Cancer Center | New Haven | Connecticut | 06510 | United States | ||
| Medical University of South Carolina |
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| ID | Title | Description |
|---|---|---|
| FG000 | Unframed Messaging | Unframed smoking cessation materials Unframed messaging materials: Unframed smoking cessation materials |
| FG001 | Gain-framed Messaging | Gain-framed messaging Gain-framed messaging : Gain-framed messaging materials |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline population consists of all consented and randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | Unframed Messaging | Unframed smoking cessation materials Unframed messaging materials: Unframed smoking cessation materials |
| BG001 | Gain-framed Messaging | Gain-framed messaging Gain-framed messaging: Gain-framed messaging materials |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 | Smoking Cessation - Available Data | Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit | All available participants are included in the analysis of 7 day point prevalence abstinence at the 6-month follow up visit. | Posted | Count of Participants | Participants | 6 month follow-up |
|
Adverse events were collected from study entry to the conclusion of the 6-month follow up session or when a participant withdrew from the study.
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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 | Unframed Messaging | Unframed smoking cessation materials Unframed messaging materials: Unframed smoking cessation materials |
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Due to low accrual for this clinical trial during the COVID pandemic, we worked with our study statistician and NCI Program Officer to collapse our 4 arm trial to 2 arms. This allowed us to meet our accrual goal and complete the study while still retaining the ability to test our Primary Aim.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Benjamin Toll | Medical University of South Carolina | 843-876-1132 | toll@musc.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 | Nov 14, 2022 | Oct 21, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 16, 2022 | Oct 17, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| Unframed messaging materials |
| Combination Product |
Unframed smoking cessation materials |
|
| 6 Month Follow up Visit |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| Cigarettes Smoked Per Day | Mean | Standard Deviation | Cigarettes Smoked Per Day, Average |
|
| Abstinent at Study Baseline | Count of Participants | Participants |
|
|
|
| Secondary | Cigarettes Smoked Per Day - Average | Gain-framed messaging vs. Unframed messaging - average reported cigarettes smoked per day. | all participants with data available at the 6-month follow up visit. | Posted | Mean | 95% Confidence Interval | Average Cigarettes Smoked Per Day | 6 month follow-up |
|
|
|
| Secondary | Smoking Cessation - Imputed | Gain-framed messaging vs. Unframed messaging. 7-day, self-reported abstinence from cigarettes at the 6- month follow-up visit. Missing participant data imputed to no cessation. 3 participants from the unframed group were not included as they had died prior to the 6-month visit. | all randomized participants whom were alive at the 6-month follow up visit. | Posted | Count of Participants | Participants | 6 Month Follow up Visit |
|
|
|
| 3 |
| 183 |
| 0 |
| 183 |
| 0 |
| 183 |
| EG001 | Gain-framed Messaging | Gain-framed messaging Gain-framed messaging : Gain-framed messaging materials | 0 | 184 | 0 | 184 | 0 | 184 |
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