Clinical trial NCT03064971: Enhancing Quitline Services for African American Smokers
Official title: Enhancing Quitline Services for African American Smokers: RCT of an Evidence-Based DVD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Cessation
Keywords: Quitline
culturally specific
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
name: Consumer Wellness Solutions
name: North Carolina Tobacco Quitline
First posted: 2017-02-27
Enrollment: 1050
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Recent quitters (have not smoked in past 7 days)
* Medical contraindications for nicotine replacement therapy (NRT)

Primary outcomes:
measure: Cotinine-verified 7-day point-prevalence abstinence (ppa)
timeFrame: At 6 months
Secondary outcomes:
measure: Cotinine-verified 7-day ppa
timeFrame: At 3 months
measure: Cotinine-verified 24-hour ppa
timeFrame: At 3 months
measure: Cotinine-verified 24-hour ppa
timeFrame: At 6 months
measure: 28-day continuous abstinence
timeFrame: At 3 months
measure: 28-day continuous abstinence
timeFrame: At 6 months
Other outcomes:
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, Carpenter K, Payne M, Resnicow K. Effects of a culturally specific tobacco cessation intervention among African American Quitline enrollees: a randomized controlled trial. BMC Public Health. 2018 Jan 10;18(1):123. doi: 10.1186/s12889-017-5015-z.