TY - JOUR
T1 - Development of a colorectal cancer screening intervention for Alaska Native people during a pandemic year
AU - Flanagan, Christie A.
AU - Finney Rutten, Lila J.
AU - Kisiel, John B.
AU - Lent, Jennifer K.
AU - Bachtold, Joseph F.
AU - Swartz, Andrew W.
AU - Redwood, Diana G.
N1 - Funding Information:
The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Dr. Rutten provides scientific input to research studies through a contracted services agreement between Mayo Clinic and Exact Sciences. Dr. Kisiel is listed as an inventor of Mayo Clinic intellectual property, licensed to Exact Sciences (Madison, Wisconsin), for which he may receive royalties, paid to Mayo Clinic. He consults and receives research support under a sponsored research agreement between Mayo Clinic and Exact Sciences. All other authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.This research was supported by the National Institutes of Health National Cancer Institute under award number R01CA247642. We acknowledge the contributions and support of the Alaska Native Tribal Health Consortium and the Yukon-Kuskokwim Health Corporation Boards of Directors; Exact Sciences, who provided Cologuard® test kits and preprocessing materials and implementation support at no cost; and the Alaska State Laboratory, who provided laboratory space at no cost. The content presented is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Funding Information:
This research was supported by the National Institutes of Health National Cancer Institute under award number R01CA247642 . We acknowledge the contributions and support of the Alaska Native Tribal Health Consortium and the Yukon-Kuskokwim Health Corporation Boards of Directors; Exact Sciences, who provided Cologuard® test kits and preprocessing materials and implementation support at no cost; and the Alaska State Laboratory, who provided laboratory space at no cost. The content presented is solely the responsibility of the authors and does not necessarily represent the official views of the NIH.
Publisher Copyright:
© 2022
PY - 2022/12
Y1 - 2022/12
N2 - Objectives: Alaska Native (AN) people experience twice the rate of colorectal cancer (CRC) as US Whites. There is a need for increased screening and early detection. We describe the development and implementation of a randomized controlled trial of the multi-target stool DNA test (mt-sDNA; Cologuard® Exact Sciences, Madison WI) to increase CRC screening among AN people. Methods: A total of 32 rural/remote AN communities were randomized to a varied intensity intervention (patient navigation vs mailed health education) compared to 14 communities receiving usual opportunistic care. Outcome measures include screening completion and method used (mt-sDNA vs colonoscopy). Health care provider interviews and AN patient focus groups will be used to assess patient-, provider-, and system-level CRC screening promoters and barriers. Results: The study began in April 2020 during the COVID-19 pandemic, resulting in a number of challenges and study adaptations. These included difficulty finding laboratory space, lack of timely mail service due to flight reductions across the state, and travel restrictions that led to postponement of in-person focus groups. Videoconferencing platforms for Tribal engagement replaced face-to-face interactions. After an extensive search, a laboratory with space available was identified and the preprocessing laboratory established. Study staff will work closely with patients to monitor mail service to get mt-sDNA kits sent on time. We are also exploring the use of videoconferencing platforms as alternatives to in-person focus groups. Conclusions: Despite the challenges encountered during the COVID-19 pandemic, we successfully initiated the intervention and established the first mt-sDNA preprocessing laboratory in Alaska.
AB - Objectives: Alaska Native (AN) people experience twice the rate of colorectal cancer (CRC) as US Whites. There is a need for increased screening and early detection. We describe the development and implementation of a randomized controlled trial of the multi-target stool DNA test (mt-sDNA; Cologuard® Exact Sciences, Madison WI) to increase CRC screening among AN people. Methods: A total of 32 rural/remote AN communities were randomized to a varied intensity intervention (patient navigation vs mailed health education) compared to 14 communities receiving usual opportunistic care. Outcome measures include screening completion and method used (mt-sDNA vs colonoscopy). Health care provider interviews and AN patient focus groups will be used to assess patient-, provider-, and system-level CRC screening promoters and barriers. Results: The study began in April 2020 during the COVID-19 pandemic, resulting in a number of challenges and study adaptations. These included difficulty finding laboratory space, lack of timely mail service due to flight reductions across the state, and travel restrictions that led to postponement of in-person focus groups. Videoconferencing platforms for Tribal engagement replaced face-to-face interactions. After an extensive search, a laboratory with space available was identified and the preprocessing laboratory established. Study staff will work closely with patients to monitor mail service to get mt-sDNA kits sent on time. We are also exploring the use of videoconferencing platforms as alternatives to in-person focus groups. Conclusions: Despite the challenges encountered during the COVID-19 pandemic, we successfully initiated the intervention and established the first mt-sDNA preprocessing laboratory in Alaska.
KW - Alaska Native
KW - Colorectal neoplasms/prevention and control
KW - Community-based participatory research
KW - Healthcare disparities
KW - Multi-target stool DNA
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U2 - 10.1016/j.conctc.2022.101016
DO - 10.1016/j.conctc.2022.101016
M3 - Article
AN - SCOPUS:85140274613
SN - 2451-8654
VL - 30
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
M1 - 101016
ER -