Path2Quit Tobacco Intervention For African Americans

NCT03524482 | Completed

• 1 other identifier: CASE1Y18
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Smoking, Tobacco

Keywords

culturally specific

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Number of missed nicotine replacement therapy doses

  Up to 1-month follow-up

• 24-Hour quit attempts

  At 1-month follow-up

• Changes in carbon monoxide breath levels from baseline to followup

  At 1-month follow-up

• Changes in Contemplation ladder score

  From baseline to up to 1-month follow-up

• Average score of Intervention Evaluation (IRQ)

  At 1-month follow-up

Other Outcomes (8)

• Average scores of Urban hassles

  Changes from baseline to 1 month follow-up

• Average Neighborhood Environment scale score

  At Baseline

• Average General Ethnic Discrimination Scale Score

  At baseline

Study Arms (2)

Path2Quit

EXPERIMENTAL

Culturally specific text message intervention

Behavioral: Path2Quit

SmokeFreeText

ACTIVE COMPARATOR

The National Cancer Institute's publicly available, standard text messaging program for tobacco cessation

Behavioral: SmokeFreeText

Interventions

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.

Also known as: SmokefreeTXT

SmokeFreeText

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.

Path2Quit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (1)

• 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.

  PMID: 34647777 DERIVED

MeSH Terms

Conditions

Smoking Cessation; Tobacco Smoking

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking; Tobacco Use

Study Officials

• Monica Webb Hooper, PhD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 30, 2018
• First Posted: May 14, 2018
• Study Start: April 1, 2018
• Primary Completion: August 20, 2018
• Study Completion: August 20, 2018
• Last Updated: March 28, 2019

Record last verified: 2019-03

Locations

US (1)