Smoking Cessation Clinical Trial
Official title:
Development and Pilot Evaluation of the Path2Quit Tobacco Intervention Targeting African Americans
NCT number | NCT03524482 |
Other study ID # | CASE1Y18 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | April 1, 2018 |
Est. completion date | August 20, 2018 |
Verified date | March 2019 |
Source | Case Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 119 |
Est. completion date | August 20, 2018 |
Est. primary completion date | August 20, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Case Western Reserve University, Case Comprehensive Cancer Center | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
Case Comprehensive Cancer Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Average scores of Urban hassles | This is a 63 item scale scored 0-5 (total score 0-315) where higher scores indicate more severe hassle | Changes from baseline to 1 month follow-up | |
Other | Average Neighborhood Environment scale score | The neighborhood environment scale is an 18 item True or False scale | At Baseline | |
Other | Average General Ethnic Discrimination Scale Score | 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 | At baseline | |
Other | Average psychological distress score using the the perceived stress scale | 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. | At baseline | |
Other | Average depression score using Center for Epidemiological Studies Depression (CES-D) Scale | A twenty item scale ranging from 0-60 with each item scored 0-3. Higher scores indicate more depression | At baseline | |
Other | Average Beliefs and Attitudes Survey Score | 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 | |
Other | Average Ethnic Identity Score | 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 | |
Other | Average Culturally Specific Interventions Expectancy Questionnaire | 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. | At baseline | |
Primary | Proportion of participants who abstain from smoking | Abstinence will be coded as a binary variable. Analysis will be conducted with an intent to treat approach | At 1-month follow-up | |
Secondary | Number of missed nicotine replacement therapy doses | Measure of NRT adherence. Number of missed doses will be recorded for each participant | Up to 1-month follow-up | |
Secondary | 24-Hour quit attempts | Number of times a participant quits smoking for at least 24 hours | At 1-month follow-up | |
Secondary | Changes in carbon monoxide breath levels from baseline to followup | Breath carbon monoxide tests will biochemically confirm self-reported cessation | At 1-month follow-up | |
Secondary | Changes in Contemplation ladder score | self-reported score 0-10 where a higher score indicates more readiness to quit | From baseline to up to 1-month follow-up | |
Secondary | Average score of Intervention Evaluation (IRQ) | The IRQ is a 22 item scale scored 0-7 (total score 0-154) where higher scores indicate more satisfaction | At 1-month follow-up | |
Secondary | Average score of smoking urges | This brief, 10 item scale is scores 1-7 (total score 10-70) with higher scores indicating greater agreement | Up to 1-month follow-up |
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