Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers
3 other identifiers
interventional
26
1 country
1
Brief Summary
The goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Nov 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2015
CompletedStudy Start
First participant enrolled
November 2, 2015
CompletedFirst Posted
Study publicly available on registry
November 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 22, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 22, 2017
CompletedResults Posted
Study results publicly available
March 10, 2020
CompletedMarch 10, 2020
March 1, 2020
1.8 years
November 2, 2015
May 14, 2018
March 2, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Intervention Feasibility & Acceptability
The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = "Extremely Unsatisfied" to 5 = "Extremely Satisfied"). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating greater levels of satisfaction. Treatment group session satisfaction group means were tabulated by group (calculated as the average for all participants in each treatment group) and used as a proxy measure of overall intervention acceptability and feasibility.
Averaged across 3 study visits (Week 0 to Week 12)
Patch Adherence: Percentage of Days With Patch
Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure.
This outcome was collected at each study timepoint and measured the 12 weeks of NRT patch treatment.
Number of Abstinent Participants
Rates of biochemically verified 7-day point prevalence smoking abstinence. Collected with the Timeline Follow-back interview procedure and verified with a expired carbon monoxide testing with a Bedfont Smokelyzer monitor.
Collected at the 3- and 6-month follow-up visits
Study Arms (3)
Health Education (HE) Group
EXPERIMENTALParticipants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
Culturally Tailored Smoking Cessation (CTSC) Group
EXPERIMENTALParticipants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
Culturally Tailored Smoking + Adherence Enhancement (AE) Group
EXPERIMENTALParticipants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).
Interventions
Participants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches.
Questionnaires regarding tobacco and alcohol use, culture, religion, and sense of control completed at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.
Carbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.
Participants receive general health education and handouts.
Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting.
Participants attend 3 counseling sessions during the study.
Eligibility Criteria
You may qualify if:
- Adults at least 18 years of age
- Current smoker (\>5 cigarettes per day for the past 3 months)
- Able to speak and read English or Spanish
- Agree to participate in the study and be available for 6 weeks of treatment and 6 months of follow-up
- Willing to set a quit date within 2 weeks of enrollment date
- Identify as being of Latino heritage, ethnicity, or ancestry
You may not qualify if:
- Individuals suffering from any unstable medical condition precluding the use of NRT (Identified using the Medical History Questionnaire given at baseline)
- Currently using smokeless tobacco, electronic nicotine delivery systems (ENDS), nicotine replacement therapy, or other smoking cessation treatment
- Pregnant or nursing
- Suffering from a severe psychiatric disorder (assessed using self-reporting history of psychiatric diagnosis during the phone screening) that would interfere with participation
- Diagnosis of substance dependence other than nicotine (screened using DSM IV TR criteria) Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition
- Individuals that do not have access to a working telephone
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
de Dios MA, Cano MA, Vaughan EL, Childress SD, McNeel MM, Harvey LM, Niaura RS. A pilot randomized trial examining the feasibility and acceptability of a culturally tailored and adherence-enhancing intervention for Latino smokers in the U.S. PLoS One. 2019 Jan 11;14(1):e0210323. doi: 10.1371/journal.pone.0210323. eCollection 2019.
PMID: 30633744DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Due to the limited scope, the study was not fully powered for conclusive hypothesis testing of group differences on variables of interest. The analytic strategy focused on descriptive statistics and estimation rather than formal hypothesis testing.
Results Point of Contact
- Title
- Dr. Marcel A. de Dios / Health Disparities Research
- Organization
- UT MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Marcel A. de Dios, PHD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 2, 2015
First Posted
November 4, 2015
Study Start
November 2, 2015
Primary Completion
August 22, 2017
Study Completion
August 22, 2017
Last Updated
March 10, 2020
Results First Posted
March 10, 2020
Record last verified: 2020-03