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Completed

NCT Number: NCT03524482

Path2Quit Tobacco Intervention For 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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior Smoking Smoking, Tobacco Tobacco Smoking Tobacco Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SmokeFreeText

Behavioral

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: SmokefreeTXT

Path2Quit

Behavioral

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.

Primary outcomes

  1. Proportion of participants who abstain from smoking

    Time frame: At 1-month follow-up

    Abstinence will be coded as a binary variable. Analysis will be conducted with an intent to treat approach

Secondary outcomes

  1. 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

  2. 24-Hour quit attempts

    Time frame: At 1-month follow-up

    Number of times a participant quits smoking for at least 24 hours

  3. Changes in carbon monoxide breath levels from baseline to followup

    Time frame: At 1-month follow-up

    Breath carbon monoxide tests will biochemically confirm self-reported cessation

  4. Changes in Contemplation ladder score

    Time frame: From baseline to up to 1-month follow-up

    self-reported score 0-10 where a higher score indicates more readiness to quit

  5. Average score of Intervention Evaluation (IRQ)

    Time frame: At 1-month follow-up

    The IRQ is a 22 item scale scored 0-7 (total score 0-154) where higher scores indicate more satisfaction

  6. Average score of smoking urges

    Time frame: Up to 1-month follow-up

    This brief, 10 item scale is scores 1-7 (total score 10-70) with higher scores indicating greater agreement

Other outcomes

  1. Average scores of Urban hassles

    Time frame: Changes from baseline to 1 month follow-up

    This is a 63 item scale scored 0-5 (total score 0-315) where higher scores indicate more severe hassle

  2. Average Neighborhood Environment scale score

    Time frame: At Baseline

    The neighborhood environment scale is an 18 item True or False scale

  3. Average General Ethnic Discrimination Scale Score

    Time frame: At baseline

    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

  4. Average psychological distress score using the the perceived stress scale

    Time frame: At baseline

    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.

  5. Average depression score using Center for Epidemiological Studies Depression (CES-D) Scale

    Time frame: At baseline

    A twenty item scale ranging from 0-60 with each item scored 0-3. Higher scores indicate more depression

  6. 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

  7. 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

  8. Average Culturally Specific Interventions Expectancy Questionnaire

    Time frame: At baseline

    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.

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 14, 2018
Registry last updated
Mar 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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