Path2Quit Tobacco Intervention For African Americans

Smoking Cessation Clinical Trial

Official title:

Development and Pilot Evaluation of the Path2Quit Tobacco Intervention Targeting African Americans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03524482
• Other study ID #: CASE1Y18
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: August 20, 2018

Study information

• Verified date: March 2019
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Smoking Cessation
• Smoking, Tobacco

Intervention

Behavioral:
• SmokeFreeText
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.
• Path2Quit
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.

Locations

Country	Name	City	State
United States	Case Western Reserve University, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

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