Trial Outcomes & Findings for Spanish-Language Smoking Cessation Trial (NCT NCT02945787)
NCT ID: NCT02945787
Last Updated: 2022-11-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1417 participants
Primary outcome timeframe
6 months
Results posted on
2022-11-04
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
714
|
703
|
|
Overall Study
COMPLETED
|
714
|
703
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Spanish-Language Smoking Cessation Trial
Baseline characteristics by cohort
| Measure |
Extended Self-help
n=714 Participants
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.
|
Usual Care (UC)
n=703 Participants
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.
|
Total
n=1417 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
648 Participants
n=5 Participants
|
643 Participants
n=7 Participants
|
1291 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
66 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
126 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
346 Participants
n=5 Participants
|
339 Participants
n=7 Participants
|
685 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
368 Participants
n=5 Participants
|
364 Participants
n=7 Participants
|
732 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
12 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
17 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
23 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
347 Participants
n=5 Participants
|
313 Participants
n=7 Participants
|
660 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
293 Participants
n=5 Participants
|
301 Participants
n=7 Participants
|
594 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
714 participants
n=5 Participants
|
703 participants
n=7 Participants
|
1417 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsParticipants 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.
Outcome measures
| Measure |
Extended Self-help
n=714 Participants
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.
|
Usual Care (UC)
n=703 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Tobacco Abstinence at 6 Months
|
21.7 percentage of participants
|
11.3 percentage of participants
|
PRIMARY outcome
Timeframe: 12 monthsParticipants 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.
Outcome measures
| Measure |
Extended Self-help
n=714 Participants
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.
|
Usual Care (UC)
n=703 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Tobacco Abstinence at 12 Months
|
28.4 percentage of participants
|
17.0 percentage of participants
|
PRIMARY outcome
Timeframe: 18 monthsParticipants 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.
Outcome measures
| Measure |
Extended Self-help
n=714 Participants
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.
|
Usual Care (UC)
n=703 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Tobacco Abstinence at 18 Months
|
29.3 percentage of participants
|
20.7 percentage of participants
|
PRIMARY outcome
Timeframe: 24 monthsParticipants 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.
Outcome measures
| Measure |
Extended Self-help
n=714 Participants
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.
|
Usual Care (UC)
n=703 Participants
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.
|
|---|---|---|
|
Percentage of Participants With Tobacco Abstinence at 24 Months
|
33.1 percentage of participants
|
23.3 percentage of participants
|
Adverse Events
Extended Self-help
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Care (UC)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place