Clinical trial NCT04259762: Enhancing Cancer Prevention and Control Pathways-Native Health Initiative
Official title: Enhancing Cancer Prevention and Control Pathways-Native Health Initiative
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Breast
Cancer, Colon
Cancer, Cervix
Keywords: breast neoplasm
colorectal neoplasm
cervical neoplasm
screening
behavioral interventions
American Indians
cost-effectiveness analysis
cluster randomization
community-based participatory research
Lead sponsor: New Mexico Cancer Research Alliance
Sponsor class: OTHER
Collaborators: name: University of New Mexico
name: National Institute of General Medical Sciences (NIGMS)
First posted: 2020-02-06
Enrollment: 192
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria: Breast Cancer Screening Intervention

* Women age 50-75
* Average risk for breast cancer
* Never had a mammogram OR not had a mammogram within the past 2 years
* Residing in the Zuni Pueblo

Exclusion Criteria: Breast Cancer Screening Intervention. Meeting at least one of the following criteria:

* Women with breast implants, pregnant, or breast feeding
* History of breast cancer
* Have new breast complaints such as lump or nipple discharge

Inclusion Criteria: Colorectal Cancer Screening Intervention

* Men and women aged 50-75
* Average risk for colorectal cancer
* Never had a fecal occult blood test (FOBT), or fecal immunochemical test (FIT) or a colonoscopy OR not had a FOBT or FIT in the past year, OR no colonoscopy in the past 10 years
* Residing in the Zuni Pueblo

Exclusion Criteria: Colorectal Cancer Screening Intervention. Meeting at least one of the following criteria:

* History of colorectal cancer, total colectomy, adenomatous polyps, or inflammatory bowel disease
* Up-to-date with colorectal cancer screening
* Severe comorbidity
* Incarceration
* Family history of colorectal cancer
* Hospice/terminal care status

Inclusion Criteria: Cervical Cancer Screening Intervention

* Women aged 21-65
* Never had a cytology (Pap smear) OR had a Pap smear more than 3 years ago OR women aged 30-75, and never had screening with a combination of cytology and human papillomavirus testing OR no combination of testing in the past 5 years
* Residing in the Zuni Pueblo

Exclusion Criteria: Cervical Cancer Screening Intervention. Meeting at least one of the following criteria:

* History of total hysterectomy
* High risk for cervical cancer due to suppressed immune system (e.g., HIV infection, organ transplant, long-term steroid use)
* Women over age 65 who have had regular screenings with normal results

Primary outcomes:
measure: Completion of a Mammogram exam to screen for breast cancer
timeFrame: Within 6 months from end of the intervention
measure: Completion of a Fecal Immunochemical Test kit to screen for colorectal cancer
timeFrame: Within 6 months from end of the intervention
measure: Completion of a Pap Smear test to screen for cervical cancer
timeFrame: Within 6 months from end of the intervention
Secondary outcomes:
measure: Change in Knowledge measured using the Health Behavior Survey
timeFrame: Baseline (Day 0), Posttest 1 (1 month post-baseline), Posttest 2 (12 months post-baseline)
measure: Change in Attitudes measured using the Health Behavior Survey
timeFrame: Baseline (Day 0), Posttest 1 (1 month post-baseline), Posttest 2 (12 months post-baseline)
measure: Change in Perceived Control measured using the Health Behavior Survey
timeFrame: Baseline (Day 0), Posttest 1 (1 month post-baseline), Posttest 2 (12 months post-baseline)
measure: Change in Perceived Susceptibility measured using the Health Behavior Survey
timeFrame: Baseline (Day 0), Posttest 1 (1 month post-baseline), Posttest 2 (12 months post-baseline)
measure: Change in Perceived Severity measured using the Health Behavior Survey
timeFrame: Baseline (Day 0), Posttest 1 (1 month post-baseline), Posttest 2 (12 months post-baseline)
measure: Change in Self-Efficacy measured using the Health Behavior Survey
timeFrame: Baseline (Day 0), Posttest 1 (1 month post-baseline), Posttest 2 (12 months post-baseline)
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico - Cancer Center
state: New Mexico
Study officials:
affiliation: University of New Mexico School of Medicine
name: Shiraz I Mishra, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: