Enhancing Quitline Services for African American Smokers
- Conditions
- Tobacco Use Cessation
- Registration Number
- NCT03064971
- Lead Sponsor
- Case Comprehensive Cancer Center
- Brief Summary
This study proposes to test the value of a culturally specific program for African American smokers to quit smoking.
- Detailed Description
The intervention to be tested, Pathways to Freedom (PTF), is a video-based program that will be examined as an adjunct to tobacco cessation services provided through a state quitline. Investigators will conduct a 3-arm randomized controlled trial (RCT) to obtain real-world evidence for the efficacy of the PTF DVD. Participants will be randomly assigned to receive standard care plus PTF DVD, standard care plus standard smoking cessation DVD, or standard care only; assessments will occur at baseline, 3, and 6 months post-enrollment. All participants will receive nicotine replacement therapy (NRT). Thus, the impact of the PTF DVD will be isolated, informing investigators whether standard telephone counseling can be enhanced by the provision of a culturally specific DVD-based intervention. The primary abstinence outcome will be cotinine-verified 7-day point-prevalence abstinence (ppa) at the 6-month follow-up; secondary outcomes will be 7-day ppa at 3-months, 24-hour ppa, and 28-day continuous abstinence.
Objective 1: To test the efficacy of an innovative evidence-based smoking cessation DVD targeting African American smokers. Investigators will conduct a 3-arm randomized controlled trial (RCT) to obtain real-world evidence for the efficacy of the Pathway to Freedom (PTF) DVD. Participants will be randomly assigned to receive standard care plus PTF DVD, standard care plus standard smoking cessation DVD, or standard care only; assessments will occur at baseline, 3, and 6 months post-enrollment. All participants will receive nicotine replacement therapy (NRT). Thus, the impact of the PTF DVD will be isolated, informing us of whether standard telephone counseling can be enhanced by the provision of a culturally specific DVD-based intervention. The primary abstinence outcome will be cotinine-verified 7-day point-prevalence abstinence (ppa) at the 6-month follow-up; secondary outcomes will be 7-day ppa at 3-months, 24-hour ppa, and 28-day continuous abstinence. Controlling for covariates (any group differences in socio-demographics, smoking history, and NRT use), the study hypothesizes that standard care plus the PTF DVD will produce greater abstinence rates compared to standard care plus a standard cessation DVD. In this study, it is also expect that the greater abstinence rates in the PTF DVD condition will be maintained over time.
Objective 2: To examine the effect of the PTF DVD on treatment engagement. Previous research suggests that culturally specific interventions are preferred by African American smokers compared to standard interventions. This preference may impact engagement in treatment, which would also represent an important indicator of success. Controlling for baseline differences, this study hypothesizes that the PTF DVD will lead to greater engagement in treatment, specifically positive evaluations of the telephone counseling and smoking cessation DVDs, session length, completed counseling sessions, DVD viewing, NRT use, use of coping strategies, and study retention compared to the standard DVD control group.
Objective 3 (exploratory): To assess the feasibility of delivering the PTF DVD in an online format. Although there are several indications that a DVD format is cutting edge for African American smokers, who tend to be of lower socioeconomic status and have less Internet access, the study will assess the acceptability and utilization of delivering the video interventions in an online format. Specifically, at the 3 and 6-month follow-ups, participants will rate their satisfaction and experience with accessing the videos in each condition via a private YouTube channel, and report the frequency of online viewing. As this is an exploratory aim, there is no specific hypotheses.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1050
- Self-identification as Black/African American
- Current smokers (smoked at least 100 lifetime cigarettes and currently smoke on some or every day) who would like help quitting
- Eligible for state quitline services
- Access to devices that play DVDs
- Permanent contact information
- Recent quitters (have not smoked in past 7 days)
- Medical contraindications for nicotine replacement therapy (NRT)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Cotinine-verified 7-day point-prevalence abstinence (ppa) At 6 months number of patients who self-report abstinence from tobacco at 6 months who have confirmed abstinence with a test of saliva for cotinine, an alkaloid found in tobacco
- Secondary Outcome Measures
Name Time Method Cotinine-verified 7-day ppa At 3 months number of patients at 3 months who self-report abstinence from tobacco for 7 days who have confirmed abstinence with a test of saliva for cotinine, an alkaloid found in tobacco
Cotinine-verified 24-hour ppa At 6 months number of patients at 6 months who self-report abstinence from tobacco for 24 hours who have confirmed abstinence with a test of saliva for cotinine, an alkaloid found in tobacco
28-day continuous abstinence At 6 months number of patients at 6 months who self-report abstinence from tobacco for 28 days who have confirmed abstinence with a test of saliva for cotinine, an alkaloid found in tobacco
Trial Locations
- Locations (1)
Case Western Reserve University, Case Comprehensive Cancer Center
🇺🇸Cleveland, Ohio, United States
Case Western Reserve University, Case Comprehensive Cancer Center🇺🇸Cleveland, Ohio, United States