Urban and Reservation Implementation of All Nations Breath of Life (NCT04931810) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Urban and Reservation Implementation of All Nations Breath of Life
United States576 participantsStarted 2021-04-08
Plain-language summary
This is an implementation trial of the All Nations Breath of Life (ANBL) smoking cessation program, which has already been tested for efficacy in reservation populations and shown feasibility in urban populations. It includes four implementation sites, two reservation sites and two urban sites. Therefore, investigators plan to test efficacy simultaneously. Implementation will follow guidelines described in the protocol, with all sites implementing certain parts of the intervention the same way, with the freedom to modify some aspects of the intervention for appropriate use in their communities. Statistical considerations are described in the appropriate section.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Self-identified American Indian or allowed to enroll by community site
* Age 18 or older
* Smokes at least one cigarette per day
* Planning to quit smoking
* Have a home address and telephone number
* Willing to be followed for 6 months
* Willing to participate
Exclusion Criteria:
\- Any of the above do not apply
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Smoking Cessation
Timeframe: 7-day point prevalence abstinence at 6 months