Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06436300
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2024-05-24
Brief Title:
Colorectal Cancer Screening in Alaska Native Men
Sponsor:
Washington State University
Organization:
Washington State University
Study Overview
Official Title:
Increasing Colorectal Cancer Screening in Alaska Native Men
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Alaska Native men have the highest rates of colorectal cancer incidence and mortality in the US Screening can prevent disease and improve survival We previously developed an intervention that uses text messages to increase colorectal cancer screening in Alaska Native patients of the Southcentral Foundation healthcare system in Anchorage Alaska The intervention improved screening by 50 in women but it had no effect in men We propose to culturally tailor the intervention for Alaska Native Men and to test it with a randomized controlled trial among 600 patients at the Southcentral Foundation This will be the first trial of an intervention designed to increase colorectal cancer screening in Alaska Native men
Detailed Description:
Alaska Native men have higher colorectal cancer CRC incidence and mortality than any other US racial or ethnic group Screening can prevent CRC and improve treatment outcomes by detecting disease in early stages but Alaska Native men also have low CRC screening uptake Colonoscopy is the most accurate CRC screening method and results in the most years of life saved It only requires rescreening every 10 years but it is a clinic- based procedure and needs extensive preparation Other screening options include home-based tests that detect blood in the stool and require rescreening every year More recently a home-based method has been developed that tests stool for DNA indicative of CRC and requires rescreening every 3 years Current guidelines recommend CRC screening for average risk adults starting between ages 45-50 but people at higher risk should start at younger ages Many interventions have been developed to promote CRC screening Among these interventions that use text messaging or other electronic health messages to reach people outside of the clinical setting have shown promise for improving CRC screening In a previous study our research team developed an intervention that sends up to 3 text messages to Alaska Native people patients of the Southcentral Foundation SCF healthcare system in Anchorage Alaska We tested the intervention in a randomized controlled trial with 2386 Alaska Native SCF patients ages 40-75 The intervention increased CRC screening by 50 in women but it had no effect in men In the current implementation study we propose a theory-based approach to culturally tailor the existing text message intervention for Alaska Native men We will use surveys and focus groups with SCF patients and key informant interviews with SCF healthcare providers to assess barriers and facilitators to optimize colorectal cancer screening in Alaska Native men We anticipate that revisions will include changing the content and frequency of the text messages and promoting home-based stool DNA screening in addition to colonoscopy We will then test the effectiveness of the tailored intervention with 600 Alaska Native men ages 40-75 who are active patients at SCF Eligible men will be identified from the electronic medical record and randomized in equal proportions to the intervention or usual care control conditions The primary outcome is CRC screening completed within 6 months of sending the first text message Secondary outcomes include clinical findings and follow-up procedures associated with screening All data will be collected from the electronic medical record and we will obtain a waiver of consent for direct patient recruitment Follow-up interviews will assess patient response to the intervention If effective this study has implications for increasing CRC screening in men from other racial and ethnic minority groups who experience CRC disparities
Public Health Relevance Statement
Public Health Relevance Statement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None