Smoking CessationNCT02945787
Spanish-Language Smoking Cessation Trial
A study testing Spanish-Language Version of the Stop Smoking for Good and NCI-Produced Spanish-language Self-help Booklet in people with Smoking Cessation, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Spanish-Language Version of the Stop Smoking for Good and NCI-Produced Spanish-language Self-help Booklet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,417 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Oct 2016to Jul 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
Official title: Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Trial
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.
- Conditions
- Smoking Cessation
- Being tested
- Spanish-Language Version of the Stop Smoking for Good, NCI-Produced Spanish-language Self-help Booklet
- Keywords
- Spanish speaking, self-help, tobacco abstinence, public health, Forever Free, Stop Smoking for Good
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spanish-Language Version of the Stop Smoking for GoodBehavioural
Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months.
NCI-Produced Spanish-language Self-help BookletBehavioural
Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Spanish-Language Version of the Stop Smoking for Good |
| 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. Receives: Behavioral: NCI-Produced Spanish-language Self-help Booklet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study start24 Oct 2016
- Primary completionJul 2020
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,417 participants (actual)
Sponsor and investigators
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Florida Department of Health
- Responsible party
- Sponsor
- Investigators
- Thomas Brandon, Ph.D., Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02945787
- Sponsor's protocol ID
- MCC-18633
- Other IDs
- R01CA199143
- Status last verified
- Nov 2022
- First submitted
- 25 Oct 2016
- Last updated
- 4 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34679188
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanding the Reach of a Validated Smoking-Cessation Intervention: A Spanish-Language Trial
- ClinicalTrials.gov ID
- NCT02945787
- Acronym / sponsor ID
- MCC-18633
- Conditions
- Smoking Cessation
- Keywords
- Spanish speaking, self-help, tobacco abstinence, public health, Forever Free, Stop Smoking for Good
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,417 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Florida Department of Health
- Study start
- 24 Oct 2016 (actual)
- Primary completion
- Jul 2020 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 26 Oct 2016 (estimated)
- Results
- Posted 16 Sep 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extended Self-help | Experimental | Behavioral: Spanish-Language Version of the Stop Smoking for GoodSpanish-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. |
| Usual Care (UC) | Active comparator | Behavioral: NCI-Produced Spanish-language Self-help BookletNCI-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spanish-Language Version of the Stop Smoking for GoodParticipants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months. | Behavioural | Extended Self-help |
| NCI-Produced Spanish-language Self-help BookletParticipants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet. | Behavioural | Usual Care (UC) |
Primary outcome
Percentage of Participants With Tobacco Abstinence at 6 Months
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34679188Simmons 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.
- Moffitt Cancer Center Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Brandon, Ph.D. principal investigator
H. Lee Moffitt Cancer Center and Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spanish-Language Version of the Stop Smoking for Good and NCI-Produced Spanish-language Self-help Booklet in people with Smoking Cessation, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Sep 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Tobacco Abstinence at 6 Months (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02945787, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2022.