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Completed

NCT Number: NCT03064971

Enhancing Quitline Services for African American Smokers

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Standard Care

Behavioral

Standard of care provided by QuitlineNC includes Quit Coaches, counseling calls, nicotine replacement therapy, and written materials

smoking cessation DVD

Behavioral

The evidence-based "How to Quit" DVD contains 60 minutes of smoking cessation information and strategies

PTF DVD

Behavioral

Culturally specific smoking cessation DVD. This DVD contains 60 minutes of material.

Other names: Pathways to Freedom DVD

Primary outcomes

  1. Cotinine-verified 7-day point-prevalence abstinence (ppa)

    Time frame: 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 outcomes

  1. Cotinine-verified 7-day ppa

    Time frame: 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

  2. Cotinine-verified 24-hour ppa

    Time frame: At 3 months

    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

  3. Cotinine-verified 24-hour ppa

    Time frame: 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

  4. 28-day continuous abstinence

    Time frame: At 3 months

    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

  5. 28-day continuous abstinence

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Collaborators

  • American Cancer Society, Inc.
  • Consumer Wellness Solutions
  • North Carolina Tobacco Quitline

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Feb 27, 2017
Registry last updated
Aug 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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