Mark B Dignan1, Kate Jones2, Linda Burhansstipanov3, Sheikh I Ahamed4, Linda U Krebs5, Drew Williams6, G M Tanimul Ahsan7, Ivor Addo8, Michele Sargent9, Kristin Cina10, Kim Crawford11, Doris Thibeault12, Simone Bordeaux13, Shalini Kanekar14, Daniel Petereit15. 1. Prevention Research Center, University of Kentucky, Lexington, KY 40522, USA. Electronic address: mark.dignan@uky.edu. 2. Prevention Research Center, University of Kentucky, Lexington, KY 40522, USA. 3. Native American Cancer Initiatives, Inc., 3022 South Nova Road, Pine, CO 880470-7830, United States of America. Electronic address: LindaB@NatAmCancer.net. 4. Ubicomp research lab Marquette University, P.O. Box 1881, 1313 W. Wisconsin Avenue, Milwaukee, WI 53201, United States of America. Electronic address: sheikh.ahamed@marquette.edu. 5. Native American Cancer Initiatives, Inc., 3022 South Nova Road, Pine, CO 880470-7830, United States of America. Electronic address: linda.krebs@ucdenver.edu. 6. Ubicomp research lab Marquette University, P.O. Box 1881, 1313 W. Wisconsin Avenue, Milwaukee, WI 53201, United States of America. 7. Computer Science, University of Wisconsin - Green Bay, Green Bay, WI 54311, United States of America. Electronic address: ahsang@uwgb.edu. 8. College of Business, University of Wisconsin - Oshkosh, Oshkosh, WI 54901, United States of America. Electronic address: addoid@uwosh.edu. 9. Avera Research Institute, Avera Health, 4940 5(th) Street Suite 1C, Rapid City, SD 57701, United States of America. Electronic address: Michele.Sargent@avera.org. 10. Avera Research Institute, Avera Health, 4940 5(th) Street Suite 1C, Rapid City, SD 57701, United States of America. Electronic address: Kristin.cina@avera.org. 11. Avera Research Institute, Avera Health, 4940 5(th) Street Suite 1C, Rapid City, SD 57701, United States of America. 12. Avera Research Institute, Avera Health, 4940 5(th) Street Suite 1C, Rapid City, SD 57701, United States of America. Electronic address: Doris.thibeault@avera.org. 13. Avera Research Institute, Avera Health, 4940 5(th) Street Suite 1C, Rapid City, SD 57701, United States of America. Electronic address: Simone.bordeaux@avera.org. 14. Regional Cancer Care Institute, Rapid City Regional Hospital, 353 Fairmount Blvd, Rapid City, SD 57701, USA; Clinical Affairs, Prometic Biotherapeutics Inc., Rockville, MD 20850, United States of America. 15. Regional Cancer Care Institute, Rapid City Regional Hospital, 353 Fairmount Blvd, Rapid City, SD 57701, USA. Electronic address: DPetereit@regionalhealth.com.
Abstract
BACKGROUND: Lung cancer is an important public health issue, particularly among American Indians (AIs). The reported decline in tobacco use for most racial/ethnic groups is not observed among AIs. This project was designed to address the research question, "Why don't more Northern Plains American Indians alter tobacco use behaviors known to increase the risk of cancer?" METHODS: Guided by the Theory of Planned Behavior, a multi-component intervention study was implemented. Adult AIs, age 18 years or older and currently smoking, were enrolled. Eligible subjects were randomized to one of 15 groups and exposed to either a MINIMAL or an INTENSE level of 4 intervention components. The intervention was delivered face-to-face or via telephone by Patient Navigators (PN). The primary outcome was self-reported abstinence from smoking verified by carbon monoxide measurement. RESULTS: At 18 months post-quit date, 88% of those who were still in the study were abstinent. This included 6% of all participants who enrolled in the study (14/254) and 13% of those who made it to the quit date (14/108). No intervention groups were found to have significant proportions of participants who were abstinent from smoking at the quit date (visit 5) or primary outcome visit (18 months post-quit date, visit 11), but use of pharmacologic support for abstinence was found to be an effective strategy for individuals who continued participation throughout the study. Those who remained in the study received more visits and were more likely to be abstinent. CONCLUSIONS: Use of NRT increased the odds of not smoking, as assessed at the 18-month follow-up visit, but no other interventions were found to significantly contribute to abstinence from smoking. Although the intervention protocol included numerous points of contact between CRRs and participants (11 visits) loss to follow-up was extensive with only 16/254 remaining enrolled. Additional research is needed to improve understanding of factors that influence enrollment and retention in smoking cessation interventions for AI and other populations.
RCT Entities:
BACKGROUND:Lung cancer is an important public health issue, particularly among American Indians (AIs). The reported decline in tobacco use for most racial/ethnic groups is not observed among AIs. This project was designed to address the research question, "Why don't more Northern Plains American Indians alter tobacco use behaviors known to increase the risk of cancer?" METHODS: Guided by the Theory of Planned Behavior, a multi-component intervention study was implemented. Adult AIs, age 18 years or older and currently smoking, were enrolled. Eligible subjects were randomized to one of 15 groups and exposed to either a MINIMAL or an INTENSE level of 4 intervention components. The intervention was delivered face-to-face or via telephone by Patient Navigators (PN). The primary outcome was self-reported abstinence from smoking verified by carbon monoxide measurement. RESULTS: At 18 months post-quit date, 88% of those who were still in the study were abstinent. This included 6% of all participants who enrolled in the study (14/254) and 13% of those who made it to the quit date (14/108). No intervention groups were found to have significant proportions of participants who were abstinent from smoking at the quit date (visit 5) or primary outcome visit (18 months post-quit date, visit 11), but use of pharmacologic support for abstinence was found to be an effective strategy for individuals who continued participation throughout the study. Those who remained in the study received more visits and were more likely to be abstinent. CONCLUSIONS: Use of NRT increased the odds of not smoking, as assessed at the 18-month follow-up visit, but no other interventions were found to significantly contribute to abstinence from smoking. Although the intervention protocol included numerous points of contact between CRRs and participants (11 visits) loss to follow-up was extensive with only 16/254 remaining enrolled. Additional research is needed to improve understanding of factors that influence enrollment and retention in smoking cessation interventions for AI and other populations.
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