Smoking Cessation
Conditions
Keywords
Spanish speaking, self-help, tobacco abstinence, public health, Forever Free, Stop Smoking for Good
Brief summary
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.
Interventions
BEHAVIORALSpanish-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.
BEHAVIORALNCI-Produced Spanish-language Self-help Booklet
Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet.
Sponsors
National Cancer Institute (NCI)
Florida Department of Health
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Smoking ≥ 5 tobacco cigarettes/week over the past year * Not currently enrolled in a face-to-face smoking cessation program * Monolingual Spanish-speaking, or bilingual Spanish-English and prefer receiving educational health materials in Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Tobacco Abstinence at 6 Months | 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. |
| Percentage of Participants With Tobacco Abstinence at 12 Months | 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. |
| Percentage of Participants With Tobacco Abstinence at 18 Months | 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. |
| Percentage of Participants With Tobacco Abstinence at 24 Months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 714 |
| 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. | 703 |
| Total | 1,417 |
Baseline characteristics
| Characteristic | Extended Self-help | Usual Care (UC) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 66 Participants | 60 Participants | 126 Participants |
| Age, Categorical Between 18 and 65 years | 648 Participants | 643 Participants | 1291 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 12 Participants | 30 Participants | 42 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 23 Participants | 18 Participants | 41 Participants |
| Race (NIH/OMB) More than one race | 20 Participants | 28 Participants | 48 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 17 Participants | 13 Participants | 30 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 293 Participants | 301 Participants | 594 Participants |
| Race (NIH/OMB) White | 347 Participants | 313 Participants | 660 Participants |
| Region of Enrollment United States | 714 participants | 703 participants | 1417 participants |
| Sex: Female, Male Female | 346 Participants | 339 Participants | 685 Participants |
| Sex: Female, Male Male | 368 Participants | 364 Participants | 732 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended Self-help | Percentage of Participants With Tobacco Abstinence at 12 Months | 28.4 percentage of participants |
| Usual Care (UC) | Percentage of Participants With Tobacco Abstinence at 12 Months | 17.0 percentage of participants |
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.
Time frame: 18 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended Self-help | Percentage of Participants With Tobacco Abstinence at 18 Months | 29.3 percentage of participants |
| Usual Care (UC) | Percentage of Participants With Tobacco Abstinence at 18 Months | 20.7 percentage of participants |
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.
Time frame: 24 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended Self-help | Percentage of Participants With Tobacco Abstinence at 24 Months | 33.1 percentage of participants |
| Usual Care (UC) | Percentage of Participants With Tobacco Abstinence at 24 Months | 23.3 percentage of participants |
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.
Time frame: 6 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Extended Self-help | Percentage of Participants With Tobacco Abstinence at 6 Months | 21.7 percentage of participants |
| Usual Care (UC) | Percentage of Participants With Tobacco Abstinence at 6 Months | 11.3 percentage of participants |