Enhancing Quitline Services for African American Smokers



Status:Recruiting
Conditions:Smoking Cessation
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - Any
Updated:6/14/2018
Start Date:May 22, 2017
End Date:June 15, 2021
Contact:Monica Webb Hooper, PhD
Email:mwh54@case.edu
Phone:216-368-6895

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Enhancing Quitline Services for African American Smokers: RCT of an Evidence-Based DVD

This study proposes to test the value of a culturally specific program for African American
smokers to quit smoking.

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.

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)
We found this trial at
1
site
10900 Euclid Avenue
Cleveland, Ohio 44106
Principal Investigator: Monica Webb Hooper, PhD
Phone: 216-368-6895
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mi
from
Cleveland, OH
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