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Innovations to Prevent Relapse Among Low-income African American Smokers

Primary Purpose

Smoking Cessation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nicotine replacement therapy (NRT)
CS-CBT intervention
Path2Quit
Relapse prevention program
SmokefreeTXT
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking Cessation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult smokers recruited from the community by study community navigator and flyers
  • Self-identify as African American
  • Report no tobacco smoking within the past 3-90 days and have a carbon monoxide (CO) reading of ≤ 3 ppm
  • Have access to SMS texting
  • Meet federal definitions of low-income

Exclusion Criteria:

- Study team will offer to enroll ineligible smokers in the publicly available smokefreeTXT (if applicable) or refer them to the Ohio state quitline

Sites / Locations

  • Case Western Reserve University, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CS Relapse Prevention

Standard Relapse Prevention

Arm Description

Participants will receive 4 group sessions of a novel culturally specific, CBT-based intervention. They will also receive Path2Quit, a newly developed video-text program, which delivers 6 weeks of CS video messages (1-2 times/day) and provides 24/7 access to messages pulled from 3 keywords (HELP1, JONES, SLIP). Notably, CS relapse prevention will incorporate surface and deep structure elements,17 including race-matched interventionists, religion/spirituality, discussion of race-related stress, traditional values (e.g., collectivism), culturally specific recipes, etc. All participants will receive 4 weeks of nicotine replacement therapy (NRT; transdermal nicotine patches or nicotine gum).

Participants will receive 4 group sessions of a standard relapse prevention program, publicly available at smokefree.gov. Participants will also receive SmokefreeTXT, the NCI's 6-week fully automated text-based cessation program that is free to U.S. subscribers, and is available on smokefree.gov. Users can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system 24/7. All participants will receive 4 weeks of nicotine replacement therapy (NRT; transdermal nicotine patches or nicotine gum).

Outcomes

Primary Outcome Measures

Biochemically verified point prevalence abstinence (ppa)
Biochemically verified point prevalence abstinence (ppa) confirmed by breath carbon monoxide and saliva cotinine will confirm self-reported cessation at each follow-up.
Time to smoking relapse (TTR)
Time to smoking relapse (TTR) over a 3 month period

Secondary Outcome Measures

Smoking urges
Measured through Weekly the Questionnaire of Smoking Urges (QSU) with scores ranging from 10-70, higher scores indicating greater urges.
Percent of participants adhering to nicotine replacement therapy (NRT)
Timeline follow-back (TLFB) instrument used to record daily use of NRT per day. The TLFB is a calendar that assesses daily smoking and NRT use. Based on participants' reconstruction of their smoking history, abstinence variables will be determined. For instance, if there has been no smoking in the 7 days preceding the assessment, the criterion for 7-day point prevalence abstinence (ppa) will be met.

Full Information

First Posted
May 28, 2019
Last Updated
November 3, 2021
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03982576
Brief Title
Innovations to Prevent Relapse Among Low-income African American Smokers
Official Title
Innovations to Prevent Relapse Among Low-income African American Smokers
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this research is to study a relapse prevention program for adult former smokers in Northeast Ohio. The study will also look at how different people respond to the program. Participants asked to take part in this study because they contacted the team for help remaining tobacco-free or otherwise expressed interest in the program. The study includes completing surveys and receiving text messages to help stay tobacco free.
Detailed Description
The main objective of this study is to conduct a pilot study to assess the feasibility, acceptability, and initial efficacy/clinical significance of a tobacco relapse prevention intervention designed for low-income African Americans. In this study, the team will estimate effect sizes for a culturally specific (CS) relapse prevention intervention compared to standard relapse prevention in a sample of low-income African American smokers and examine predictors of time to smoking relapse. In a community-based clinical trial, adults who recently quit smoking (N=100) will be randomly assigned to one of two experimental conditions: (1) CS Relapse Prevention or (2) Standard Relapse Prevention. The primary outcome variables collected will include biochemically verified point prevalence abstinence (ppa) at 6-weeks and time to smoking relapse (TTR) over 3-months. This study will test daily hassles, cessation self-efficacy, coping strategies, and adherence to NRT as individual difference factors that may affect response to CS relapse prevention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking Cessation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2-arm semi-pragmatic randomized design among recently quit smokers (N = 100). Random assignment (1:1 ratio, stratified by building and sex).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CS Relapse Prevention
Arm Type
Experimental
Arm Description
Participants will receive 4 group sessions of a novel culturally specific, CBT-based intervention. They will also receive Path2Quit, a newly developed video-text program, which delivers 6 weeks of CS video messages (1-2 times/day) and provides 24/7 access to messages pulled from 3 keywords (HELP1, JONES, SLIP). Notably, CS relapse prevention will incorporate surface and deep structure elements,17 including race-matched interventionists, religion/spirituality, discussion of race-related stress, traditional values (e.g., collectivism), culturally specific recipes, etc. All participants will receive 4 weeks of nicotine replacement therapy (NRT; transdermal nicotine patches or nicotine gum).
Arm Title
Standard Relapse Prevention
Arm Type
Active Comparator
Arm Description
Participants will receive 4 group sessions of a standard relapse prevention program, publicly available at smokefree.gov. Participants will also receive SmokefreeTXT, the NCI's 6-week fully automated text-based cessation program that is free to U.S. subscribers, and is available on smokefree.gov. Users can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system 24/7. All participants will receive 4 weeks of nicotine replacement therapy (NRT; transdermal nicotine patches or nicotine gum).
Intervention Type
Other
Intervention Name(s)
Nicotine replacement therapy (NRT)
Intervention Description
4 weeks of Transdermal nicotine patches or nicotine gum
Intervention Type
Behavioral
Intervention Name(s)
CS-CBT intervention
Intervention Description
4 group sessions of a novel culturally specific, CBT-based intervention over 2 weeks
Intervention Type
Behavioral
Intervention Name(s)
Path2Quit
Intervention Description
Path2Quit is a newly developed video-text program, which delivers 6 weeks of CS video messages (1-2 times/day) and provides 24/7 access to messages pulled from 3 keywords (HELP1, JONES, SLIP).
Intervention Type
Behavioral
Intervention Name(s)
Relapse prevention program
Intervention Description
4 group sessions of a standard relapse prevention program, publicly available at smokefree.gov
Intervention Type
Behavioral
Intervention Name(s)
SmokefreeTXT
Intervention Description
NCI's 6-week fully automated text-based cessation program that is free to U.S. subscribers, and is available on smokefree.gov. Users can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system 24/7
Primary Outcome Measure Information:
Title
Biochemically verified point prevalence abstinence (ppa)
Description
Biochemically verified point prevalence abstinence (ppa) confirmed by breath carbon monoxide and saliva cotinine will confirm self-reported cessation at each follow-up.
Time Frame
at 6-weeks from start of treatment
Title
Time to smoking relapse (TTR)
Description
Time to smoking relapse (TTR) over a 3 month period
Time Frame
up to 3 months from start of treatment
Secondary Outcome Measure Information:
Title
Smoking urges
Description
Measured through Weekly the Questionnaire of Smoking Urges (QSU) with scores ranging from 10-70, higher scores indicating greater urges.
Time Frame
20 minutes, 6-weeks follow-up, and 3-months from end of treatment.
Title
Percent of participants adhering to nicotine replacement therapy (NRT)
Description
Timeline follow-back (TLFB) instrument used to record daily use of NRT per day. The TLFB is a calendar that assesses daily smoking and NRT use. Based on participants' reconstruction of their smoking history, abstinence variables will be determined. For instance, if there has been no smoking in the 7 days preceding the assessment, the criterion for 7-day point prevalence abstinence (ppa) will be met.
Time Frame
20 minutes, 6-weeks follow-up, and 3-months from end of treatment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult smokers recruited from the community by study community navigator and flyers Self-identify as African American Report no tobacco smoking within the past 3-90 days and have a carbon monoxide (CO) reading of ≤ 3 ppm Have access to SMS texting Meet federal definitions of low-income Exclusion Criteria: - Study team will offer to enroll ineligible smokers in the publicly available smokefreeTXT (if applicable) or refer them to the Ohio state quitline
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monica Webb Hooper, PhD
Organizational Affiliation
Case Western Reserve University, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Western Reserve University, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

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Innovations to Prevent Relapse Among Low-income African American Smokers

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