Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02882620 |
| Other study ID # |
14-363 |
| Secondary ID |
R01CA192967 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2016 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
June 2024 |
| Source |
University of New Mexico |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Recent improvements in colorectal cancer (CRC) incidence, mortality, stage at diagnosis, and
survival in the general U.S. population have been attributed to routine screening with prompt
removal of polyps, early detection, and timely and appropriate treatment. American
Indians/Alaska Natives (AI/ANs) have not experienced improvements in CRC related outcomes and
are significantly less likely than non-Hispanic Whites to receive recommended CRC screening.
The purpose of this three-arm randomized controlled trial is to determine the efficacy of
interventions designed to enhance CRC screening. The study also uses mixed methods to
finalize the intervention and to determine promoters and barriers of screening. The study
also conducts process evaluation to determine cost-effectiveness of the interventions,
fidelity of study implementation, and to develop plans to sustain and scale-up the
intervention model. The study will determine the efficacy of serially implemented
interventions of graded intensity for increasing CRC screening using the fecal immunochemical
test (FIT) in accordance to recommended guidelines among average risk American Indians (AIs)
aged 50-75 residing on reservations in rural Southwestern U.S. Serial implementation refers
to offering routine screening, irrespective of response to an earlier invitation, in
concordance with guidelines which recommend annual FIT testing between ages 50-75. The FIT is
most appropriate because it is an approved, high sensitivity fecal occult blood test and is
available at Indian Health Service (IHS) and tribal health facilities where resources to
provide screening colonoscopy are limited. The study is a collaborative effort between the
Albuquerque Area Indian Health Board (100% Indian-owned and operated), six Pueblo Tribes in
rural Southwestern U.S., and the University of New Mexico. Findings from this research could
lead to an immediate increase in CRC screening and ultimately reduce CRC burden among AIs,
thus addressing national and tribal priorities of reducing CRC disparities among AIs.
Description:
Despite the effectiveness of CRC screening tests for average risk adults, these tests are
under-utilized by AI/ANs. A recent study of AI/ANs who utilize IHS facilities reported that
only about 4.0% of average risk AI/ANs age 50-75, compared with nearly 65% of U.S. adults,
were current with CRC screening guidelines. The overall objective is to test the efficacy of
serially implemented interventions of graded intensity designed to enhance annual CRC
screening using the FIT in AI communities. The aims are to:
Aim 1. Finalize and evaluate the efficacy of serially implemented interventions of graded
intensity for increasing annual CRC screening uptake.
Aim 2. Determine promoters and barriers to enhancing annual CRC screening practices.
Aim 3. Conduct process evaluation studies on: cost-effectiveness of the interventions,
implementation fidelity, and sustainability and scalability.
Protocol A. Aim 1-Qualitative Research (Intervention Finalization)
1. Research Design: Qualitative design, using focus group methodology.
2. Study Population: Recruited from the project's Community Advisory Council, from the
Albuquerque Area Southwest Tribal Epidemiology Center's (AASTEC's) Executive Council,
Community Health Representatives, and other tribal stakeholders.
3. Recruitment Target: Up to 30-36 eligible (assuming attrition) persons.
4. Recruitment Methods: Purposive sampling methods.
5. Procedures: Conduct three focus groups, with each group consisting of 6 to 8
participants. Each session will meet for approximately two hours. Before starting the
discussion, participants will provide informed consent and complete a survey collecting
socio-demographic information. The purpose of these focus groups is to finalize the
intervention's educational material, ensuring it is culturally appropriate and contains
messages operationalizing various constructs of the theory guiding the study (Health
behavior Framework; HBF).
B. Aim 1-Quantitative Research (Efficacy RCT)
1. Research Design: Randomly assigned, three-group, pretest-posttest design.
2. Research Setting: Six Pueblo Tribes in New Mexico.
3. Randomization: Using simple random allocation procedures.
4. Participants Identification and Sampling: Identify eligible participants from the IHS
Resource and Patient Management System (RPMS) electronic health record system. We will
invite all eligible persons (estimated at 1,700) identified through the RPMS to
participate.
5. Interventions: The interventions are graded in intensity: high intensity, medium
intensity, and reference group (usual care).
6. Procedures: After randomizing tribes to the three Groups, we will mail a recruitment
letter, a consent form for completion of surveys, and a baseline survey. We will mail
the first posttest survey 12 months after mailing the baseline survey, with the 2nd and
3rd posttest surveys mailed in successive 12-month intervals. Between the baseline and
1st posttest surveys, participants will receive the group-specific intervention. All
eligible adults will be included in the analyses for the primary outcome (ie, completion
of the FIT kit) since non-completion of a FIT is a valid response. All eligible
participants in Groups 1 and 2 will receive a mailed FIT kit whether or not they return
the baseline survey.
7. Implementation of the Intervention: We will simultaneously implement the intervention,
over three 12-month cycles. For Groups 1 and 2, we will mail the FIT kit, and the
educational material about one month following the initial recruitment letter/baseline
survey mailing. For Group 1, navigators will offer up to four education outreach
sessions. Group 2 will receive the FIT and education material mailing. Group 3 will
receive usual care (screening recommendation and a FIT kit at a clinic visit).
8. Baseline and Posttest Surveys: These surveys will collect data on CRC-related knowledge,
attitudes, perceived control, perceived susceptibility and severity, social support, and
self-efficacy. The baseline survey will also collect socio-demographic data.
9. Data Management and Analysis: We will summarize categorical and continuous variables
using descriptive statistics. For all analyses, the overall type I error rate will be
α=0.05. We will use appropriate methods such as Tukey's honest significant difference
test or a Bonferroni correction for multiple comparisons.
For the primary outcome, annual completion of the FIT kit, the primary endpoint is the
proportion of participants within each Group who completed and returned 0, 1, 2 or 3 FIT
kits. All analyses will be intent-to-treat, since all eligible participants will be
included in the analysis. We will compare the primary outcome across interventions via a
likelihood ratio test with a multiple comparisons adjustment. To summarize intervention
effects, we will report odds ratios and their 95% confidence intervals (CIs) for
completing all 3 FIT kits as compared to returning each of 2, 1, or no FIT kits.
The secondary outcomes are temporal changes in the HBF constructs (eg, knowledge,
attitudes, perceived risk) from baseline to 12-month cycles following the baseline
survey. We will assess temporal changes in the HBF constructs with repeated measures
linear regression modeling to understand the interventions' effects over time.
Predictive value of the interventions and the HBF constructs on the yearly FIT uptake
will be assessed by refitting the repeated measures logistic regression model described
in the primary analysis for the dependent variable of return of completed FIT kit (yes
vs. no) at each time point, but also including as a covariate score from all returned
surveys measuring HBF constructs. We will report odds ratios (and 95% CIs) for
completion by Groups.
10. Sample Size Considerations: We powered our study to measure significant changes by Group
in the annual completion of the FIT (primary outcome). With hypothesized proportions of
participants with 0, 1, 2 or 3 returned FIT kits that reflect an average of 4%, 14% and
24% completing the FIT each year for the three Groups, respectively, the power of the
study is ~99% with 566 participants per Group (total=1,698). We adjusted for multiple
comparisons in our power calculation by using a Bonferroni correction.
Aim 2-Qualitative Research (Understanding Behavior Change Context)
1. Research Design: Qualitative design.
2. Study Population: Participants "largely adherent" (completed FIT 2 or 3 of 3 times) and
"not adherent" (completed FIT 0 or 1 of 3 times) to guidelines; navigators; providers
and medical directors of IHS facilities.
3. Recruitment Target: Up to 120-144 participants (assuming attrition) who took part in the
Aim 1 Efficacy RCT; with 60 participants "largely adherent" and 60 participants "not
adherent" to the FIT guidelines. All the navigators (n=3) working on the project and
medical directors (n=3) of the three participating IHS facilities. One health care
provider from each of the three participating IHS facilities (n=3).
4. Recruitment Methods: Purposive sampling methods.
5. Procedures: Conduct 12 focus groups, with each group consisting of 6 to 8 participants.
Each session will meet for approximately two hours. Before starting the discussion,
participants will provide informed consent. The moderator will explore HBF factors most
conducive to being "largely adherent" to screening guidelines. Among participants "not
adherent" to CRC screening guidelines, we will inquire about barriers to completing a
FIT and their potential solutions. We will also inquire about how we can sustain and
scale-up the interventions for broader dissemination.
Conduct interviews with navigators, and health care providers and medical directors of the
IHS facilities. Before starting the interview, we will obtain informed consent. Interviews
with the navigators will focus on delivery of the intervention, barriers and promoters to
providing navigation, participants' reasons for "largely adhering" or "not adhering" to CRC
screening guidelines, and strategies to sustain and scale-up the interventions. Interviews
with the health care providers and medical directors will focus on systems-level factors that
may or may not facilitate delivery of CRC screening services, viability of using navigation
for cancer screening in community settings, and strategies to sustain and scale-up the
interventions. We will collect baseline socio-demographic information from the participants.
Aim 3-Process Evaluation Studies (Cost-Effectiveness Analysis, Implementation Fidelity, and
Sustainability and Scalability)
1. Procedure-Cost-Effectiveness Analysis: We will collect and use primary and secondary
data to define parameters for the Markov models of cost-effectiveness. We will include
data on CRC epidemiology in New Mexico, screening and treatment costs, and screening
compliance rates for each cycle of the serially implemented interventions. We will
collect data on all costs including navigation, mailing of FITs, educational material,
and follow-up costs by each Group. We will assess direct medical costs through the IHS
RPMS, which contains patient encounter-level data by outpatient ICD-9 diagnoses and
procedure codes. We will extract data on sensitivity, specificity and efficacy of
screening tests from the peer-reviewed literature. We will begin by constructing a
decision tree for each of the Groups. We will compute the costs of each decision node
(FIT completed/FIT not completed and received colonoscopy/did not receive colonoscopy)
based on directly accrued medical and non-medical costs obtained from data sources
identified above. The result of the cost-effectiveness analysis will be an incremental
cost-effectiveness ratio (ICER) for the three Groups.
2. Procedure-Implementation Fidelity: We will evaluate fidelity of implementation based on
standard components, including: reach to potentially eligible participants; recruitment;
resources and expertise needed for the research; the broader content (ie, social,
physical, cultural, and structural factors); fidelity of delivery of the interventions;
amount of the intervention actually delivered; amount of the intervention actually
received; challenges encountered in implementing the research; potential contamination;
and number and quality of partnerships.
3. Procedure-Sustainability and Scalability: We will operationalize concepts for sustaining
and scaling-up efficacious interventions, including: the nature of the interventions;
the interventions' efficacy; the cost and cost-effectiveness of the interventions;
partnerships; organizational capacity; contextual factors; promoters and barriers; and
generalizability to other populations.
