NCT02611076

Brief Summary

The purpose of this study is to develop and test a series of culturally relevant and appropriate booklets in Spanish, designed to assist Hispanic smokers in quitting smoking and remaining smoke-free.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 15, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 18, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 11, 2016

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

12 months

First QC Date

November 18, 2015

Last Update Submit

January 14, 2022

Conditions

Smoking CessationTobacco Dependence

Keywords

smoking cessationself-helpSpanish language

Outcome Measures

Primary Outcomes (2)

  • Study I: Completion of the Development of the Spanish Language Version of Smoking Cessation Materials

    Complete formative research, including focus groups and learner verification interviews to adapt Spanish language intervention materials in preparation for a randomized controlled trial.

    Up to 12 months

  • Study II: Rate of Smoking Cessation

    Smoking cessation rates based on 7-day-point-prevalence abstinence (not smoking at all for 7 consecutive days) per study arm.

    Up to 24 months

Study Arms (2)

Stop Smoking for Good Intervention in Spanish

EXPERIMENTAL

Study II: Stop Smoking for Good Intervention in Spanish (SS-SP) will comprise a series of 10 booklets distributed over 18 months, plus additional monthly contacts via 9 supportive pamphlets developed in Study I. Behavioral: Stop Smoking for Good Intervention in Spanish (SS-SP) Assessments will occur at six-month intervals, through 24 months.

Behavioral: Stop Smoking for Good Intervention in Spanish (SS-SP)

Usual Care

ACTIVE COMPARATOR

Study II: Usual Care (UC) will comprise a single, Spanish-language, smoking cessation booklet developed by the National Cancer Institute (NCI). Behavioral: Usual care (UC) Assessments will occur at six-month intervals, through 24 months.

Behavioral: Usual care (UC)

Interventions

Stop Smoking for Good Intervention in Spanish (SS-SP)BEHAVIORAL

Assessments will occur at six-month intervals, through 24 months.

Stop Smoking for Good Intervention in Spanish
Usual care (UC)BEHAVIORAL

Assessments will occur at six-month intervals, through 24 months.

Usual Care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All Except Study I; Phase I Focus Group: monolingual Spanish, or bilingual Spanish-English and prefer receiving educational health materials in Spanish.
  • Study I; Phase I Focus Group Only: Able to speak and read in English and Spanish.
  • ≥ 1 year history of smoking
  • Smoking ≥ 5 cigarettes per week
  • Age ≥ 18 years
  • Not currently enrolled in a face-to-face smoking cessation program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Links

MeSH Terms

Conditions

Smoking CessationTobacco Use Disorder

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Vani N. Simmons, Ph.D.

    H. Lee Moffitt Cancer Center and Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2015

First Posted

November 20, 2015

Study Start

October 15, 2015

Primary Completion

October 11, 2016

Study Completion

October 28, 2021

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)