Clinical trial NCT03524482: Path2Quit Tobacco Intervention For African Americans
Official title: Development and Pilot Evaluation of the Path2Quit Tobacco Intervention Targeting African Americans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Smoking, Tobacco
Keywords: culturally specific
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-05-14
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: We will conduct a 2-arm semi-pragmatic randomized design among current tobacco users (N=100). CMHA 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 purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Proportion of participants who abstain from smoking
timeFrame: At 1-month follow-up
Secondary outcomes:
measure: Number of missed nicotine replacement therapy doses
timeFrame: Up to 1-month follow-up
measure: 24-Hour quit attempts
timeFrame: At 1-month follow-up
measure: Changes in carbon monoxide breath levels from baseline to followup
timeFrame: At 1-month follow-up
measure: Changes in Contemplation ladder score
timeFrame: From baseline to up to 1-month follow-up
measure: Average score of Intervention Evaluation (IRQ)
timeFrame: At 1-month follow-up
measure: Average score of smoking urges
timeFrame: Up to 1-month follow-up
Other outcomes:
measure: Average scores of Urban hassles
timeFrame: Changes from baseline to 1 month follow-up
measure: Average Neighborhood Environment scale score
timeFrame: At Baseline
measure: Average General Ethnic Discrimination Scale Score
timeFrame: At baseline
measure: Average psychological distress score using the the perceived stress scale
timeFrame: At baseline
measure: Average depression score using Center for Epidemiological Studies Depression (CES-D) Scale
timeFrame: At baseline
measure: Average Beliefs and Attitudes Survey Score
timeFrame: At baseline
measure: Average Ethnic Identity Score
timeFrame: At baseline
measure: Average Culturally Specific Interventions Expectancy Questionnaire
timeFrame: At baseline
Locations:
city: Cleveland
country: United States
facility: Case Western Reserve University, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Case Comprehensive Cancer Center
name: Monica Webb Hooper, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Webb Hooper M, Miller DB, Saldivar E, Mitchell C, Johnson L, Burns M, Huang MC. Randomized controlled trial testing a video-text tobacco cessation intervention among economically disadvantaged African American adults. Psychol Addict Behav. 2021 Nov;35(7):769-777. doi: 10.1037/adb0000691. Epub 2021 Oct 14.