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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA199143 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Florida Department of Health | OTHER_GOV |
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Results of a recently completed National Cancer Institute (NCI) funded trial of an intervention, Forever Free: Stop Smoking for Good, revealed high efficacy throughout the 24- month follow-up period, further supporting the utility of extended self-help for promoting and maintaining tobacco abstinence. Investigators have recognized that wide-scale implementation, and therefore public health impact, would be enhanced by the availability of a Spanish-language version to reach the largest and fastest growing ethnic minority population of smokers.
The goal of this study is to address this gap by testing a Spanish-language version of the validated self-help smoking cessation intervention. If demonstrated effective, the proposed intervention would represent an easily disseminable and low-cost intervention with significant public health impact for Hispanic/Latino smokers throughout the United States. The aims of this project are to test the efficacy of a Spanish-language version of a validated, extended self-help intervention for smoking cessation among Spanish-speaking smokers against usual care control. Participants (N = 1400) recruited nationally will be randomized to the two arms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Self-help | Experimental | Spanish-Language Version of the Stop Smoking for Good: The Extended Self-help condition will comprise the 11 Stop Smoking for Good booklets and 9 supportive My Story pamphlets transcreated for Spanish speaking smokers. |
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| Usual Care (UC) | Active Comparator | NCI-Produced Spanish-language Self-help Booklet: The UC control condition enhances the external validity of the study by providing a comparison to an existing, credible intervention that a smoker could receive in a medical setting or elsewhere. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spanish-Language Version of the Stop Smoking for Good | Behavioral | Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Tobacco Abstinence at 6 Months | Participants will complete follow-up assessment packets at 6 month intervals through 24 months. At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates. | 6 months |
| Percentage of Participants With Tobacco Abstinence at 12 Months | Participants will complete follow-up assessment packets at 6 month intervals through 24 months. At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates. | 12 months |
| Percentage of Participants With Tobacco Abstinence at 18 Months | Participants will complete follow-up assessment packets at 6 month intervals through 24 months. At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates. | 18 months |
| Percentage of Participants With Tobacco Abstinence at 24 Months | Participants will complete follow-up assessment packets at 6 month intervals through 24 months. At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates. | 24 months |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Brandon, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34679188 | Derived | Simmons VN, Sutton SK, Medina-Ramirez P, Martinez U, Brandon KO, Byrne MM, Meade CD, Meltzer LR, Brandon TH. Self-help smoking cessation intervention for Spanish-speaking Hispanics/Latinxs in the United States: A randomized controlled trial. Cancer. 2022 Mar 1;128(5):984-994. doi: 10.1002/cncr.33986. Epub 2021 Oct 22. |
| Label | URL |
|---|---|
| Moffitt Cancer Center Clinical Trials website | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Extended Self-help | Spanish-Language Version of the Stop Smoking for Good: The Extended Self-help condition will comprise the 11 Stop Smoking for Good booklets and 9 supportive My Story pamphlets transcreated for Spanish speaking smokers. Spanish-Language Version of the Stop Smoking for Good: Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months. |
| FG001 | Usual Care (UC) | NCI-Produced Spanish-language Self-help Booklet: The UC control condition enhances the external validity of the study by providing a comparison to an existing, credible intervention that a smoker could receive in a medical setting or elsewhere. NCI-Produced Spanish-language Self-help Booklet: Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet. Outcomes will be assessed through 24 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Extended Self-help | Spanish-Language Version of the Stop Smoking for Good: The Extended Self-help condition will comprise the 11 Stop Smoking for Good booklets and 9 supportive My Story pamphlets transcreated for Spanish speaking smokers. Spanish-Language Version of the Stop Smoking for Good: Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months. |
| 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, 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 | Percentage of Participants With Tobacco Abstinence at 6 Months | Participants will complete follow-up assessment packets at 6 month intervals through 24 months. At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates. | Posted | Number | percentage of participants | 6 months |
|
Adverse events were not collected
Adverse events were not collected
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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 | Extended Self-help | Spanish-Language Version of the Stop Smoking for Good: The Extended Self-help condition will comprise the 11 Stop Smoking for Good booklets and 9 supportive My Story pamphlets transcreated for Spanish speaking smokers. Spanish-Language Version of the Stop Smoking for Good: Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas H. Brandon PhD | Moffitt Cancer Center | 813 745-1750 | Thomas.Brandon@moffitt.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 | Oct 30, 2018 | Jul 27, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D015438 | Health Behavior |
| D001519 | Behavior |
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| NCI-Produced Spanish-language Self-help Booklet | Behavioral | Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet. |
|
| BG001 | Usual Care (UC) | NCI-Produced Spanish-language Self-help Booklet: The UC control condition enhances the external validity of the study by providing a comparison to an existing, credible intervention that a smoker could receive in a medical setting or elsewhere. NCI-Produced Spanish-language Self-help Booklet: Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet. Outcomes will be assessed through 24 months. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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NCI-Produced Spanish-language Self-help Booklet: The UC control condition enhances the external validity of the study by providing a comparison to an existing, credible intervention that a smoker could receive in a medical setting or elsewhere. NCI-Produced Spanish-language Self-help Booklet: Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet. Outcomes will be assessed through 24 months. |
|
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| Primary | Percentage of Participants With Tobacco Abstinence at 12 Months | Participants will complete follow-up assessment packets at 6 month intervals through 24 months. At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates. | Posted | Number | percentage of participants | 12 months |
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| Primary | Percentage of Participants With Tobacco Abstinence at 18 Months | Participants will complete follow-up assessment packets at 6 month intervals through 24 months. At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates. | Posted | Number | percentage of participants | 18 months |
|
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| Primary | Percentage of Participants With Tobacco Abstinence at 24 Months | Participants will complete follow-up assessment packets at 6 month intervals through 24 months. At each assessment point, investigators will calculate 7-day point- prevalence abstinence rates. | Posted | Number | percentage of participants | 24 months |
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| EG001 | Usual Care (UC) | NCI-Produced Spanish-language Self-help Booklet: The UC control condition enhances the external validity of the study by providing a comparison to an existing, credible intervention that a smoker could receive in a medical setting or elsewhere. NCI-Produced Spanish-language Self-help Booklet: Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet. Outcomes will be assessed through 24 months. | 0 | 0 | 0 | 0 | 0 | 0 |
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