Clinical Trial Details
— Status: Active, not recruiting
Administrative data
NCT number |
NCT04336397 |
Other study ID # |
1R01CA247642-01 |
Secondary ID |
|
Status |
Active, not recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 29, 2021 |
Est. completion date |
September 15, 2024 |
Study information
Verified date |
June 2024 |
Source |
Alaska Native Tribal Health Consortium |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
Only 59% of Alaska Native people have been adequately screened for colorectal cancer (CRC)
despite having the highest reported incidence of CRC in the world. A new at-home multi-target
stool DNA screening test (MT-sDNA; Cologuard®) with high sensitivity for pre-cancerous polyps
and CRC is now available. MT-sDNA has not been tested for feasibility or acceptability within
the Alaska tribal health care delivery system, and it is unknown whether use of this new test
will increase Alaska Native CRC screening rates. The long-term study goal is to improve
screening and reduce CRC-attributable mortality. The objective of this application is to test
the effectiveness of MT-sDNA for increasing CRC screening in Alaska Native communities using
a mixed methods, community-based participatory research (CBPR) approach. The study will be
conducted in collaboration with regional Tribal health organizations responsible for
providing health care to geographically remote Alaska Native communities. Although the
proposed implementation strategy is evidence-informed and promising, it is novel in that
MT-sDNA has not been evaluated in the tribal health setting or among rural/remote
populations. Using the Social Ecological Model, the research will be multi-level, examining
influence on patients, providers, and tribal health organizations (THOs). This research study
will pursue two specific aims: (1) Identify patient-, provider-, and system-level factors
associated with CRC screening preferences, uptake, and follow-up; and (2) test the
effectiveness of graded intensity MT-sDNA intervention in the Alaska Native community
setting. For the first aim, focus groups with Alaska Native people who are not adherent to
CRC screening guidelines and interviews with healthcare providers will be used to identify
factors for future intervention. For the second aim, a three-arm cluster randomized
controlled trial (high intensity with patient navigation, medium intensity with mailed
reminders, usual care) will provide evidence on the MT-sDNA usefulness (MT-sDNA sample
quality and neoplastic yield) as well as the first data on MT-sDNA follow up adherence rates
in the Alaska Native population, which will inform plans to scale-up the intervention model.
This research has the potential to sustainably improve public health by increasing CRC
screening rates among a rural/remote tribal population as well as provide a model for other
integrated health systems that provide care to high-risk or underserved populations in the
U.S. and worldwide.
Description:
The study will employ a cluster-randomized design, in which 26 communities within one Tribal
health region will be randomized to one of the two study intervention conditions, matched by
community size. All Alaska Native adults aged 45-75 due for colorectal cancer (CRC) screening
within each community will be offered the same intervention. At least 770 participants will
be recruited in at least 13 communities per study arm.
1. High Intensity Intervention: Participants will receive navigated tribal health worker
outreach, a mailed MT-sDNA kit, mailed culturally appropriate educational material
describing CRC screening options available and follow-up reminders
2. Medium Intensity Intervention: Participants will receive mailed culturally appropriate
educational material describing CRC screening options available, including MT-sDNA, and
navigated follow-up outreach reminders
3. Usual Care (Control arm): All other communities in the participating Tribal health
region will serve as the reference group receiving usual care (i.e., screening
recommendation at a clinic visit) Participants receiving the high intensity intervention
are expected to have a 20% increase in screening uptake while those receiving medium
intensity intervention will have a 10% increase in screening uptake over those receiving
usual care. The study will also measure MT-sDNA sample quality and neoplastic yield in
these remote Alaska Native communities. The investigators anticipate that the proportion
of MT-sDNA tests meeting quality control standards will be the same as in the general US
population (96%) and that pre-cancerous polyp detection rates at diagnostic post-MT-sDNA
colonoscopy will exceed routine clinical practice rates in the general US population
(52%-67%).
During and following the graded intensity intervention, the investigators will survey samples
of patients to evaluate their awareness and response to the CRC screening intervention. The
investigators will assess their perceived severity, perceived susceptibility, perceived
benefits, perceived barriers, and self-efficacy relevant to CRC screening as well as measure
the time-to-respond and screening method used. The study will use focus groups and key
informant interviews to learn about factors associated with screening response. For the focus
groups, AN people ages 45-75 who are unscreened or non-adherent to screening guidelines
(colonoscopy within 10 years, sigmoidoscopy within five years, or fecal occult blood testing
within preceding 12 months) will be invited to provide their views on barriers to and
facilitators of screening, including barriers described in the literature and identified in
the investigators previous work. Non-adherence will be identified through tribal medical
records. Each focus group will last up to two hours, and will include 6-8 participants. All
focus groups will be stratified by gender, and focus groups will be balanced so that
approximately equal numbers of men and women are included in the analysis.
The investigators will also conduct a brief survey and key informant interviews (6-8
clinician interviews at each location) among community health aides, providers, and tribal
health system administrators using validated measures of intervention feasibility,
acceptability, and appropriateness to characterize provider- and system-level barriers and
promotors to MT-sDNA implementation.