Enhancing Quitline Services for African American Smokers

NCT03064971 | Completed DMC

• 1 other identifier: CASE8516
• Study Type: interventional
• Target: 1,050
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Use Cessation

Keywords

Quitline; culturally specific

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Cotinine-verified 7-day ppa

  At 3 months

• Cotinine-verified 24-hour ppa

  At 3 months

• Cotinine-verified 24-hour ppa

  At 6 months

• 28-day continuous abstinence

  At 3 months

• 28-day continuous abstinence

  At 6 months

Study Arms (3)

Standard care + PTF DVD

EXPERIMENTAL

The intervention will include the standard care, with the addition of the PTF DVD. Participants randomized to this condition will receive Pathways to Freedom: Leading the Way to a Smoke-Free Community© (PTF). The content of the intervention parallels the types of education, advice, and cessation/relapse prevention strategies that are delivered in clinic and quitline contexts, except for the focus on the specific needs of the Black community. The 60- minute DVD consists of 7 sections. The cultural adaptations (e.g., focus on menthol, focus on religion/spirituality, Black images and music) were infused throughout the DVD. The PTF DVD is useable at varying levels along the readiness to quit smoking continuum, as viewers are empowered to view sections that match their interests and goals. Quit Coaches will be trained to refer participants to appropriate sections for additional help.

Behavioral: Standard Care; Behavioral: PTF DVD

Standard care + standard smoking cessation DVD

ACTIVE COMPARATOR

This arm includes standard care, plus a standard smoking cessation DVD. The evidence-based "How to Quit" DVD contains 60 minutes of smoking cessation information and strategies. Narrated by a physician, it describes the process of quitting and strategies for increasing physical activity and healthy nutrition. It includes testimonials from former smokers and dialogue among smokers in a group counseling setting. The information is presented in a standard format, intended for the general population of smokers.

Behavioral: Standard Care; Behavioral: smoking cessation DVD

Standard care only

ACTIVE COMPARATOR

Following the first counseling session, participants may receive up to 3 additional proactive counseling calls. Follow-up calls focus on challenges that may have occurred on the quit date or with the use of medication. Quit Coaches® review and modify the person's quit plan, and provide support as appropriate. Participants also receive standard self-help materials by mail, which is often referred to by Quit Coaches. For individuals who have successfully quit, the Coach will focus on relapse prevention strategies. Quit Coaches provide medication education to all participants eligible and interested in using cessation medications. This study will provide starter NRT kits (2 weeks supply) to all participants. Coaches provide decision support using a database-supported algorithm based on current scientific evidence and the product manufacturer use instructions for each drug.

Behavioral: Standard Care

Interventions

Standard Care BEHAVIORAL

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

Standard care + PTF DVD; Standard care + standard smoking cessation DVD; Standard care only

smoking cessation DVD BEHAVIORAL

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

Standard care + standard smoking cessation DVD

PTF DVD BEHAVIORAL

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

Also known as: Pathways to Freedom DVD

Standard care + PTF DVD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• American Cancer Society, Inc.: collaborator
• Consumer Wellness Solutions: collaborator
• North Carolina Tobacco Quitline: collaborator

Study Sites (1)

Case Western Reserve University, Case Comprehensive Cancer Center

Cleveland, Ohio, 44106, United States

Location

Related Publications (2)

• Webb Hooper M, Carpenter KM, Salmon EE, Resnicow K. Enhancing Tobacco Quitline Outcomes for African American Adults: An RCT of a Culturally Specific Intervention. Am J Prev Med. 2023 Dec;65(6):964-972. doi: 10.1016/j.amepre.2023.06.005. Epub 2023 Jun 10.

  PMID: 37302513 DERIVED

• 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.

  PMID: 29321008 DERIVED

MeSH Terms

Conditions

Tobacco Use Cessation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Monica Webb Hooper, PhD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2017
• First Posted: February 27, 2017
• Study Start: May 22, 2017
• Primary Completion: June 24, 2020
• Study Completion: June 24, 2020
• Last Updated: August 19, 2020

Record last verified: 2020-08

Locations

US (1)