Enhancing Quitline Services for African American Smokers

Tobacco Use Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03064971
• Other study ID #: CASE8516
• Status: Completed
• Phase: N/A
• Start date: May 22, 2017
• Est. completion date: June 24, 2020

Study information

• Verified date: August 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 1050
• Est. completion date: June 24, 2020
• Est. primary completion date: June 24, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Tobacco Use Cessation

Intervention

Behavioral:
• Standard Care
Standard of care provided by QuitlineNC includes Quit Coaches, counseling calls, nicotine replacement therapy, and written materials
• smoking cessation DVD
The evidence-based "How to Quit" DVD contains 60 minutes of smoking cessation information and strategies
• PTF DVD
Culturally specific smoking cessation DVD. This DVD contains 60 minutes of material.

Locations

Country	Name	City	State
United States	Case Western Reserve University, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (4)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	Alere Wellbeing, American Cancer Society, Inc., North Carolina Tobacco Quitline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cotinine-verified 7-day point-prevalence abstinence (ppa)	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	At 6 months
Secondary	Cotinine-verified 7-day ppa	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	At 3 months
Secondary	Cotinine-verified 24-hour ppa	number of patients at 3 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	At 3 months
Secondary	Cotinine-verified 24-hour ppa	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	At 6 months
Secondary	28-day continuous abstinence	number of patients at 3 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	At 3 months
Secondary	28-day continuous abstinence	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	At 6 months