- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03524482
Path2Quit Tobacco Intervention For African Americans
Development and Pilot Evaluation of the Path2Quit Tobacco Intervention Targeting African Americans
The purpose of this research is to study a smoking cessation program for adult smokers in Northeast Ohio. The study will also look at how different people respond to the program.
The study includes completing surveys and receiving text messages to help participants become tobacco free.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES Specific Aim 1: Translate a culturally specific video-based tobacco use intervention into a scalable mobile health (mhealth) format.
Specific Aim 2: Conduct a pilot study of the video-text intervention.
Study Design:
2-arm semi-pragmatic randomized design among current tobacco users
Cuyahoga Metropolitan Housing Authority residents will be randomly assigned to receive (1) the newly translated Path2Quit or (2) SmokeFreeText (NCI's publicly available, standard text messaging program) combined with brief behavioral counseling session plus 2 weeks of nicotine replacement therapy (NRT). Primary outcomes will include intervention evaluations (content and format), acceptability, coping strategies, engagement, and NRT adherence. Secondary variables will include 24-hour quit attempts and biochemically verified tobacco use abstinence at the 1-month follow-up. Exploratory mediational analyses will examine the roles of urban hassles, acculturation, neighborhood environment, ethnic discrimination, and psychological distress in intervention effects.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Ohio
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University, Case Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Self-identify as African American
- Either smoke at least 1 cigarettes/day or have a carbon monoxide (CO) reading of at least 4 ppm
- Consistent with SmokefreeTXT, be willing to set a quit date within the next 14 days.
- Recruited from Cleveland metropolitan housing authority or who report low income based on federal guidelines
Exclusion Criteria:
- Does not meet all of the above inclusion criteria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Path2Quit
Culturally specific text message intervention
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Path2Quit will deliver 20-60 second video clips by multimedia messaging service.
The message library will include 75-170 messages.
Written text messages will be limited to brief phrases to indicate the topic of the video.
Messages will be pushed to participants in the morning, in the afternoon, and 2 hours before the reported usual bedtime.
The cultural adaptations will be infused throughout the video segments.
Topics include deep structure: race and smoking in general, African American smoking statistics; norms for smoking; concerns about nicotine replacement/medication; family/collectivism; unique stressors; racism/discrimination, depression; co-morbid addiction; neighborhood/environmental influences; menthol cigarettes; race-specific weight issues and concerns; and working as a community against the tobacco industry.
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Active Comparator: SmokeFreeText
The National Cancer Institute's publicly available, standard text messaging program for tobacco cessation
|
SmokefreeTXT is a 6-8 week fully automated text-based cessation intervention.
The program is free to U.S. subscribers who have a mobile phone, and is available on smokefree.gov
or by texting "QUIT" to short code 47848.
Participants are encouraged to set a quit date within the next 14 days, followed by count-down messages leading to the quit date.
Starting on the quit date, participants receive 6 weeks of intervention text messages, and assessment questions (mood, cravings, smoking status).
The message library contains 166 messages and 41 behavior change techniques,40 which are delivered at the greatest frequency during the first 2 weeks and taper over time.
When in need of assistance, participants can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system.
Participants can opt-out by texting STOP at any time.
With informed consent, we will be able to access the SmokefreeTXT data for these participants.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of participants who abstain from smoking
Time Frame: At 1-month follow-up
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Abstinence will be coded as a binary variable.
Analysis will be conducted with an intent to treat approach
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At 1-month follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of missed nicotine replacement therapy doses
Time Frame: Up to 1-month follow-up
|
Measure of NRT adherence.
Number of missed doses will be recorded for each participant
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Up to 1-month follow-up
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24-Hour quit attempts
Time Frame: At 1-month follow-up
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Number of times a participant quits smoking for at least 24 hours
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At 1-month follow-up
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Changes in carbon monoxide breath levels from baseline to followup
Time Frame: At 1-month follow-up
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Breath carbon monoxide tests will biochemically confirm self-reported cessation
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At 1-month follow-up
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Changes in Contemplation ladder score
Time Frame: From baseline to up to 1-month follow-up
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self-reported score 0-10 where a higher score indicates more readiness to quit
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From baseline to up to 1-month follow-up
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Average score of Intervention Evaluation (IRQ)
Time Frame: At 1-month follow-up
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The IRQ is a 22 item scale scored 0-7 (total score 0-154) where higher scores indicate more satisfaction
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At 1-month follow-up
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Average score of smoking urges
Time Frame: Up to 1-month follow-up
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This brief, 10 item scale is scores 1-7 (total score 10-70) with higher scores indicating greater agreement
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Up to 1-month follow-up
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average scores of Urban hassles
Time Frame: Changes from baseline to 1 month follow-up
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This is a 63 item scale scored 0-5 (total score 0-315) where higher scores indicate more severe hassle
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Changes from baseline to 1 month follow-up
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Average Neighborhood Environment scale score
Time Frame: At Baseline
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The neighborhood environment scale is an 18 item True or False scale
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At Baseline
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Average General Ethnic Discrimination Scale Score
Time Frame: At baseline
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This is a measure of ethnic discrimination.
These 16 items are scored 1-6 (total score 16-96) with higher scores indicating greater levels of ethnic discrimination
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At baseline
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Average psychological distress score using the the perceived stress scale
Time Frame: At baseline
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A ten item scale with each item scored 0-4 (total score 0-40) where higher scores indicate more stress.
Positive items are scored in reverse.
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At baseline
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Average depression score using Center for Epidemiological Studies Depression (CES-D) Scale
Time Frame: At baseline
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A twenty item scale ranging from 0-60 with each item scored 0-3.
Higher scores indicate more depression
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At baseline
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Average Beliefs and Attitudes Survey Score
Time Frame: At baseline
|
This is a 24 item scale (total range 24-168) with each item scored 1-7.
Higher scores indicate greater levels of agreement
|
At baseline
|
Average Ethnic Identity Score
Time Frame: At baseline
|
This is based on the Multigroup Ethnic Identity Measure scale.
These five items are scored 1-4 for a total score of 5-20.
Higher scores indicate stronger ethnic identity
|
At baseline
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Average Culturally Specific Interventions Expectancy Questionnaire
Time Frame: At baseline
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The Culturally Specific Interventions Expectancy Questionnaire is a 2 item scale with each item ranging 1-5 (total score 2-10) where higher scores indicate greater agreement.
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At baseline
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Monica Webb Hooper, PhD, Case Comprehensive Cancer Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- CASE1Y18
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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