Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04259762 |
| Other study ID # |
18-264 |
| Secondary ID |
P20GM103451 |
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2021 |
| Est. completion date |
December 31, 2024 |
Study information
| Verified date |
March 2024 |
| Source |
New Mexico Cancer Care Alliance |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
There are continued disparities in cancer incidence, mortality, and survival between American
Indians (AIs) and Whites on cancers responsive to early screening (i.e., breast, colorectal,
and cervical) in the US. In New Mexico (NM), AIs compared with other racial/ethnic
populations are significantly less likely to adhere to recommended screening guidelines. The
purpose of this trial is to develop and pilot test multilevel/multicomponent intervention
strategies to enhance screening for breast, colorectal, and cervical cancers.
Description:
There are continued disparities in cancer incidence, mortality, and survival between American
Indians (AIs) and Whites on cancers responsive to early screening (i.e., breast, colorectal,
and cervical) in the US. Between 1990-2009, based on data from Contract Health Service
Delivery Area Counties across the US, the mortality-to-incidence ratios for these cancers
were significantly higher for American Indian/Alaska Natives compared to Whites (breast:
1.22, colorectal: 1.16, cervix: 1.36), indicating poorer survival. New Mexico (NM) AIs also
experience substantial cancer disparities. Between 2010-2014, AIs compared to Whites had
higher incidence (per 100,000) for cervical (7.9 vs. 6.9) and colorectal (male: 46.5 vs.
35.2; female: 29.2 vs. 28.2) cancers, and higher mortality for cervical (3.7 vs. 1.3) and
colorectal (males only; 18.9 vs. 15.6) cancers. AIs were more likely to receive a late-stage
(i.e., regional or distant) cancer diagnosis for all 3 screen detectable cancers. AIs have
some of the lowest cancer screening rates compared with other racial/ethnic groups. In NM,
AIs listed in the Indian Health Service (IHS) Albuquerque Area have substantially lower
screening rates than the state's White population do. AIs had screening rates of: breast
(58.5%, women ages 52-64), colorectal (41.9%, ages 50-75), and cervical (63.9%, women ages
24-64) cancers; whereas, screening rates for Whites were: breast (70.0%, ages 50-74),
colorectal (69.2%, ages 50-75), and cervical (77.8%, women 21-65).
The Community Prevention Services Task Force's Guide to Community Preventive Services ("The
Community Guide") recommends evidence-based strategies for multicomponent interventions to
promote breast, colorectal, and cervical cancer screening. Multicomponent interventions
combine approaches to enhance community demand for and access to, and provider delivery of
screening services. Evidence suggests that interventions that combine approaches from the 3
strategies or that combine approaches to increase community demand and access result in the
largest increases in screening rates.
The overall objective is to develop and pilot test culturally and linguistically appropriate
interventions to enhance age- and risk-appropriate breast, colorectal, and cervical cancer
screening in concordance with the U.S. Preventive Services Task Force recommended guidelines.
The aims are to:
Aim 1. Continue to foster a sustainable multi-directional, participatory collaboration
("community collaborative" through a Tribal Advisory Panel (TAP)) between the Zuni's tribal
leadership, stakeholders, Zuni Indian Health Service Comprehensive Health Center, and UNM
Comprehensive Cancer Center (UNMCCC) researchers to enhance community-engaged cancer control
training, education, and research.
Aim 2. Using participatory approaches by engaging the TAP, finalize multilevel/multicomponent
intervention strategies to increase provider delivery of, community access to, and community
demand for screening for the screen-detectable cancers.
Aim 3. Pilot test (using a stepped-wedge trial design and qualitative methods) the
multilevel/multicomponent culturally and linguistically appropriate intervention strategies
on outcomes such as: impact on screening practices; feasibility of implementation and
acceptability of the intervention; and cost effectiveness of the intervention.
Aim 4. Disseminate findings appropriately tailored to the needs of targeted non-scientific
and scientific audiences (i.e., TAP, tribal leaders, Zuni community, Zuni IHS healthcare
providers; annual NM Institutional Development Award (IDeA) Networks of Biomedical Research
Excellence symposium and national conference attendees, and peer-reviewed publications).
Protocol A. Aim 1-Foster a Community Collaborative (TAP) Procedure-Fostering the Community
Collaborative: The 9-member community collaborative, Tribal Advisory Panel, represents the
Zuni tribal leadership, Zuni stakeholders and local organizations (i.e., Health and Wellness
program directors, Community Health Representatives [CHRs], cancer survivors), healthcare
providers (i.e., Zuni IHS Comprehensive Health Center, hereafter "health center"), and UNMCCC
researchers. The TAP ensures active community engagement and a non-hierarchical partnership
model. The TAP brings expertise in tribal health priorities and policies, cultural and
linguistic sensitivities, development and delivery of intervention, education and training
needs for students and CHRs, and delivery of healthcare services. The TAP will meet
quarterly, or more often if necessitated.
B. Aim 2-Finalize the Multilevel/Multicomponent Intervention Strategies
Procedure-Finalization of Intervention Strategies: To finalize the intervention, the
investigators will: (a) map data collected through on-going research with The Community
Guide's recommendations of evidence-based strategies to enhance cancer screening; (b) develop
small media for the 3 screen-detectable cancers.
B1. Data mapping and participatory engagement of the TAP: The investigators will map and
present data, along with evidence-based recommendations from The Community Guide, to the TAP
for participatory input on appropriate multilevel/multicomponent intervention strategies that
can enhance screening. These data were collected through prior research and consist of
environmental scans of resources available to offer screening services, and
structural/system-level promoters and barriers to providing screening and qualitative and
quantitative assessments of cancer related knowledge, attitudes, screening practices, and
screening barriers in the Zuni Pueblo.
The overall focus of the intervention model, per The Community Guide, is on intervention
strategies that fall into 3 categories. First, increase community access by reducing
structural/systemic barriers (e.g., reduce administrative barriers, patient navigation,
assist in appointment scheduling, set up alternative screening sites, and modify screening
clinic hours). Second, increase community demand using culturally, linguistically, and health
literacy appropriate group education, 1-on-1 education, client reminders and incentives, mass
media, and small media (i.e., educational brochures). Third, increase provider delivery of
screening services through, improved provider recommendations, provider reminder/recall
systems, and shared-decision making tools. Evidence suggests that a combination of strategies
from each category leads to greater effects. The investigators will conjointly work with the
TAP to select evidence-based intervention strategies (at least 1 strategy from at least 2
[preferably all 3] categories) that can best address barriers identified through the
qualitative and quantitative research, can leverage existing resources at the health center,
and meet the cancer control needs of the Zuni people.
B2. Develop small media: The investigators will develop small media (i.e., educational
brochure) on the 3 cancers. The Community Guide recommended strategies to increase demand for
and access to screening require the ability to understand cancer risk, screening benefits,
health system navigation-all to make informed decisions and take appropriate action. The
investigators will use small media to convey this information. The investigators will
operationalize the Multi-level Health Outcomes Framework (MHOF) constructs such as knowledge,
susceptibility, severity, norms, and self-efficacy in the small media, and document health
literacy using the Suitability Assessment of Materials and Comprehensibility of Materials
(SAM+CAM) instrument.
1. Research Design: Qualitative design, using focus group methodology
2. Study Population: Zuni men age 50-75 years and Zuni women age 21-75 years
3. Recruitment Target: about 30-36 eligible persons (assuming attrition)
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 materials, ensuring they are culturally appropriate and
contain messages operationalizing various constructs of the theory guiding the study
(MHOF).
6. Data Analysis: Each team member will read the transcripts independently and create
individual summaries in accordance with each domain area. The investigators will then
meet as a group to review the summaries and through a process of comparing/contrasting
observations, the investigators will distill the input into a series of recommendations
from which the investigators will modify the 3 brochures. Following the creation of
subsequent versions of the brochures, the investigators will then send them to
participants from the 3 groups for further review and comments.
7. Sample Size Considerations: While the number of focus groups cannot be precisely
determined prior to data collection, based on prior experience, 3 groups should be
sufficient to capture the full range of salient themes.
C. Aim 3: Pilot Test the Multilevel/Multicomponent Intervention C1. Quantitative Research
(Pilot Test Effectiveness of the Intervention [INT])
1. Research Design: Cluster randomized stepped-wedge
2. Research Setting: Zuni Pueblo
3. Clusters and Randomization: The investigators will form 4 cluster categories stratified
by gender and age. In all, the investigators will form 12 clusters, each comprising 10
participants. The cluster categories, number of clusters per category, and
cancer-specific INTs that the clusters will receive are as follows. (1) 5 clusters of
men aged 50-75 (for colorectal cancer INT). (2) 3 clusters of women aged 50-75 (for
breast, colorectal, and cervical cancer INTs). (3) 2 clusters of women aged 50-75 (for
breast and colorectal cancer INTs). (4) 2 clusters of women aged 21-49 (for cervical
cancer INT). The investigators will randomize each cluster and offer the cluster
category specific cancer INT(s).
4. Participant Identification and Sampling: The investigators will use a combination of
community meetings, posters, health fairs, and announcements on Zuni Radio to inform the
Pueblo residents of the study. The investigators will maintain a list by contact
information, gender, and age of those who are willing to participate in the study. The
investigators will select all members of a household eligible for any of the 3
cancer-specific INTs.
5. Interventions: Educational and behavioral interventions on cancers of the breast,
colorectal, and cervix (breast cancer screening intervention; colorectal cancer
screening intervention; and cervical cancer screening intervention).
6. Procedures: The investigators will contact (in-person) interested participants just
prior to their cluster being randomized to the INT condition and provide them with a
recruitment packet. The packet will contain materials describing the study, PI contact
information, description of the overall benefits and risks of participation, consent
letter for the surveys, and date for the first study activity (i.e., baseline survey and
first INT session). The packet will also contain a card with a unique identifier that
links the participants to the surveys and INT. The card will also contain a scheduling
calendar to inform participants about the date and time for the next project activity
(survey, INT session, focus group). Zuni students and CHRs will administer the surveys.
The investigators will conduct 3 waves of outcomes evaluation surveys: baseline,
posttest #1, and posttest #2. The investigators will administer all surveys in-person
and each will last approximately 20 minutes. Prior to each project activity, the
investigators will contact (phone or in-person) participants informing them of the date,
time and place of the upcoming activity. During each project activity, the investigators
will confirm/update the participants' contact information. Between posttest #1, and
posttest #2, the investigators will remind (phone or in-person; at 3-monthly intervals),
if necessary, participants to complete their screening exam.
7. Implementation of the Intervention [INT]: The TAP will finalize the INT strategies (Aim
2). The overall INT will be bounded by contextual realities (rurality of the Zuni
Pueblo, resources at the health center, budget for the project). With this context in
mind, the investigators could operationalize The Community Guide's recommended
strategies that the TAP may plausibly identify as follows: To increase community access,
the investigators could: (a) Identify a point-person (i.e., Public Health Nurse) at the
health center who will triage participants to and schedule them for appropriate
screening(s). (b) Remind (phone or in-person) participants (between posttest #1, and
posttest #2) to complete their screening exam(s), offer assistance in scheduling a
screening appointment and a ride to the health center. These strategies would reduce
administrative barriers, navigate participants, and assist with transportation and in
scheduling an appointment. To increase community demand, the investigators could
consider: (a) Small media. (b) 1-on-1 education (supplemented by the small media) by the
project's CHRs. (c) Reminders between posttest #1, and posttest #2. (d)
Cognitive-behavioral group education and incentives. To increase provider delivery, the
investigators could: (a) Reduce health center-specific systemic barriers by identifying
a point-person to promote and facilitate screening services.
8. Baseline and Posttest Surveys: The investigators will collect data on demographics,
knowledge, attitudes, perceived control, perceived susceptibility and severity, social
support, self-efficacy, and patient activation. At posttest #1, and posttest #2, the
investigators will inquire with whom and with how many persons they discussed the
intervention.
9. Primary Outcome: Uptake of any combination of FOBT/FIT, Pap smear, or mammogram
screening.
10. Secondary Outcome: Temporal changes on MHOF constructs and their predictive value on
screening; feasibility and acceptability (described below); cost-effectiveness
(described below); and promoters/barriers to screening (described below).
11. Data Management and Analysis:
i. Primary outcome: Completion of cancer screening. The investigators will compare the number
of cancer screening approaches undertaken by study participants, offset by the number of
possible screening tests, using Poisson regression approaches between those who are and are
not receiving active intervention. This will enable the estimation and comparison of
screening uptake between treatment arms, even when there are different numbers of possible
screening tests for groups of participants. The investigators will account for within-cluster
correlations using generalized estimating equations, and the investigators will explore the
impact on screening uptake of patient characteristics (e.g. sex) using fixed effects.
ii. Secondary outcomes. I. Feasibility/acceptability: The investigators will summarize the
various measures feasibility with descriptive statistics. The investigators will use count
and percentages for most measures, but for others, such as measures of study promotion, the
investigators will summarize the efforts undertaken using means and standard deviations, or
medians and interquartile ranges, as appropriate for the data type.
II. Promoters/barriers to screening: Analysis discussed under implementation of qualitative
data collection (Aim 3).
III. Positive changes in MHOF constructs: The investigators will also compare changes in MHOF
constructs (knowledge, attitudes, beliefs), perceived control, self-efficacy, and patient
activation, using linear mixed effects approaches that simultaneously account for
within-person and within-cluster correlations.
IV. Cost-effectiveness (CE) analysis: The investigators will utilize a Markov decision
analytical model to simulate the progression of our cohorts (across the 3 cancers: breast,
colorectal, and cervical) through predefined states: normal, local, regional, disseminated,
and death. The likelihood of progressing through states (or remaining within states) will be
derived from the literature. All 3 cancer-specific INTs will be compared to a no-screen
pathway. The difference between each INT-based pathway and its respective no-screen pathway
is a function of the change in the probability of detection across each state of cancer
progression. The analysis compares the costs and outcomes over a predetermined timeframe
(likely to be longer (20+ years) for breast and cervical and shorter for colorectal (10-20
years)). Costs and benefits will be discounted. Our main CE outcome measures will be years of
life saved (YLS), lifetime costs, and incremental cost-effectiveness ratios (cost per YLS).
Additional CE outcome measures will include: the number of new cases and deaths from cancer,
the number of new screenings, and potential deaths from new screenings (colonoscopy).
l. Sample Size Considerations: The investigators will enroll 10 participants into 12
different clusters, for a total of 120 participants. With this number of participants, and
assuming that those not in the active intervention group have historical screening uptake
levels (a weighted average of roughly 50%), then the study will have at least 80% power to
detect a relative increase in screening uptake of 20%, using a two-sided type I error level
of 5%, as long as the intra-cluster correlation is no larger than 0.62. As this degree of
intra-cluster correlation is very large, the study is well positioned to detect meaningful
intervention effects on screening uptake.
C2. Qualitative Research (Understand Behavior Change Context)
1. Research Design: Qualitative design, using focus group methodology
2. Study Population: Zuni men age 50-75 years and Zuni women age 21-75 years. Those who
completed at least 1 screening exam and those who did not complete any exam (Section
C2).
3. Recruitment Target: about 30-36 eligible persons (assuming attrition)
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 materials, ensuring they are culturally appropriate and
contain messages operationalizing various constructs of the theory guiding the study
(MHOF).
6. Data Analysis: Each team member will read the transcripts independently and create
individual summaries in accordance with each domain area. The investigators will then
meet as a group to review the summaries and through a process of comparing/contrasting
observations, the investigators will distill the input into a series of recommendations
from which the investigators will modify the 3 brochures. Following the creation of
subsequent versions of the brochures, the investigators will then send them to
participants from the 3 groups for further review and comments.
7. Sample Size Considerations: While the number of focus groups cannot be precisely
determined prior to data collection, based on prior experience, 3 groups should be
sufficient to capture the full range of salient themes.
C3. Assessment of Feasibility and Acceptability C3a. Procedure: The investigators will
analyze project records to quantify each feasibility measure. (1) Accrual (completion of
targeted enrollment): Number of eligible participants enrolled. (2) Attrition rate (<20%):
Numerator=Number of enrollees who completed the baseline survey but subsequently dropped-out
of the study at various intervals (i.e., before, during, or after completing INT, or before
either of posttest #1, and posttest #2assessments). Denominator=Total number of enrollees.
(3) Study promotion: Number of flyers distributed, nature and number of inquiries received,
and sources of such inquiries. (4) Fidelity of INT implementation (per protocol): The
investigators will define the implementation protocols to document fidelity after the TAP
finalizes the overall INT.
C4. Cost-Effectiveness Analysis C4a. Procedure: The investigators will collect and use
primary and secondary data to define parameters for the Markov models of cost-effectiveness
(CE). Primary data used for determining the CE of the intervention will include: compliance
improvements, costs related to the intervention (at both the patient (indirect) and provider
(direct) levels), age- and gender-stratified participation rates, and cancer detection rates
of the study population. Secondary data used for determining the CE of the intervention will
include: NM-specific cancer incidence, staging, and mortality rates, and direct medical costs
related to both the screening (primary costs) and treatment/management (secondary costs) of
screen-positive participants. Our data will allow estimates of screening uptake, cancer
incidence, cancer staging, treatment costs, and cancer mortality across the 3 cancer
screening interventions. The investigators will collect data on all direct medical costs
associated with the INT and follow-up, and indirect medical and non-medical costs (e.g., work
loss, travel, etc.) when possible. The investigators will assess direct medical costs through
the IHS Resource and Patient Management System (RPMS), which contains patient encounter-level
data by outpatient International Classification of Disease (ICD)-10 diagnoses and procedure
codes. The investigators will collect cancer diagnostic, treatment and inpatient data through
hospital discharge abstracts included in IHS contract billing. The investigators will use a
micro-costing approach to assess the cost of resources used or median cost of encounter based
on a resource-based relative value unit (RBRVU) system. The RBRVU is Medicare's reimbursement
rate for outpatient visits based on the procedure codes recorded for the encounter and is
used to estimate the healthcare system cost of procedures performed. Our main outcome
measures will be years of life saved (YLS), lifetime costs, and incremental
cost-effectiveness ratios (cost per YLS). Secondary outcome measures will include: the number
of new cases and deaths from cancer, the number of screenings, and potential deaths from
screenings (colonoscopy).
D. Aim 4-Dissemination D1. Procedure: The investigators will disseminate findings tailored to
targeted non-scientific and scientific audiences. The investigators present preliminary
results on an annual basis to the Zuni Tribal leadership. The investigators will also present
findings to the Tribal Advisory Panel, general community, health center providers, and the
IHS health board. The TAP will assist in these dissemination efforts. After approval from the
tribal leadership, the investigators will publish the study findings.
