Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Smoking Cessation
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Bayesian Adaptive DesignMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

We use a Bayesian Adaptive Design to examine efficacy of tANBL versus a non-tailored comparison program (CP). All participants will be offered individual telephone counseling, motivational text messaging, educational materials, and the choice of taking pharmacotherapy (must be obtained by participan...

We use a Bayesian Adaptive Design to examine efficacy of tANBL versus a non-tailored comparison program (CP). All participants will be offered individual telephone counseling, motivational text messaging, educational materials, and the choice of taking pharmacotherapy (must be obtained by participant). Participants in tANBL will receive the culturally tailored versions of all aspects of the program; participants in CP will receive non-tailored versions. Telephone All Nations Breath of Life (tANBL) Intervention Components Primary components of tANBL and their modifications from the original program are described below: Individual Sessions: The primary component of tANBL will be a series of individual support sessions, led by an AI facilitator. We will train community members in cessation support and counseling. All sessions begin with discussion of individual experiences. All facilitators can be given an extension on our toll-free line, which can be used from any computer. We will track calls, who participates, how long they last, and recordings (for supervision and training). Facilitators will, in part, use Motivational Interviewing (MI), which has been found effective among AI, enhances motivation for change, and is based on the assumption that many with addictions are not ready to change. The goal is to increase motivation through discrepancy between current behavior and goals/values. We developed culturally sensitive counseling scripts to explore positive and negative aspects of, participants' motivation and confidence for quitting smoking, the pros and cons, and plans for change. Participants are asked to identify their values and explore connections between smoking and their ability to live out their values. Participants who score lower on motivation and confidence at each session will be given more Motivational Interviewing. Text Messaging: Between phone calls, participants receive motivational culturally tailored text messaging, including messages about why smoking is detrimental to your health, respecting the sacred nature of tobacco, simple motivational messages to continue trying to quit or stay quit, etc., based on our educational curriculum. We have a database of motivational messages developed during the pilot of tANBL; we will develop and add more messages throughout program implementation to keep messaging relevant and fresh. Educational Curriculum: Our curriculum includes 11 brochures and combines the latest cessation methods with culturally specific elements, including substantial information about tobacco as a sacred plant for many, though not all, AI tribes, historical trauma, and medical/research mistrust issues, among other topics. Participants have stressed that cultural issues must be ingrained in the program, not given "lip service" with pictures of AI on otherwise "white" materials. Current materials were created by our team, community advisors, partner organizations, and previous ANBL participants, then sent to an AI graphic artist for layout. Educational materials for this project will be given to participants in paper form based on preferences of our pilot participants. Materials are available electronically if a participant wishes. Pharmacotherapy: Current treatment guidelines suggest pharmacotherapy be offered to all smokers trying to quit; participants have choice of pharmacotherapy, including varenicline, bupropion, nicotine replacement therapy (NRT, patches, gum, or lozenges), a combination, or none, as current best practices suggest. We considered providing pharmacotherapy as a part of the study, as we have done in some previous ANBL studies. However, after discussions with our community partners (particularly tribal partners), we learned that they would prefer a more real-world scenario where participants can choose to purchase nicotine replacement therapy or see their personal physician for a prescription. Previous ANBL participants have also told us that they would have been able to obtain pharmacotherapy without the study and that our provision of it was not a determining factor in them taking it. After those discussions, we decided to not provide free pharmacotherapy to our pilot tANBL participants. They were instead given the choice to purchase nicotine replacement therapy or obtain a prescription from their personal physicians. We still discussed all of the available options and allowed participants to ask questions of both facilitators and the study physician to allow for an informed decision. Based on feedback from our pilot participants, this was a good approach and we continue it for the efficacy test of tANBL. We will track use of the different types of pharmacotherapy and will examine how it affects quit rates. We will also ask participants who choose not to use any pharmacotherapy about reasons for their choice. Non-Tailored Comparison Program (CP) Intervention Components To best test our program, we use similar components to the intervention: Individual Telephone Sessions: CP arm participants will receive weekly phone calls from non-AI facilitators who will go over similar information using non-tailored materials from the American Cancer Society, through the web portal. Facilitators will not discuss traditional tobacco, historical trauma, or other AI specific topics. They will talk less about social support, as is more common in non-tailored programs. Text Messaging: CP arm participants will receive non-tailored text messaging. Educational Curriculum: Non-tailored educational brochures will be provided. Pharmacotherapy: All participants will be provided with education about pharmacotherapy.

Tracking Information

NCT #
NCT04764175
Collaborators
  • National Institute on Drug Abuse (NIDA)
  • University of Kansas Medical Center
Investigators
Principal Investigator: Christine M Daley, PhD, MA, SM Lehigh University