Clinical trial NCT03569761: A Culturally-adapted Colorectal Cancer Screening Decision Aid Designed for American Indians
Official title: A Randomized Trial of a Culturally-adapted Colorectal Cancer Screening Decision Aid Designed for American Indians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: colorectal cancer screening
decision aids
American Indians
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 128
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The investigators will use a two-group randomized controlled trial to achieve our aims. Participants (n=120) will be randomized to view the AI culturally-adapted decision aid or an attention-control (i.e., food safety) video. The study flow diagram (Figure 2) indicates the recruitment, randomization, and assessment process.Our research to develop and evaluate the decision aid is approved by the Lumbee Tribal Council and the institutional review board (IRB) at the University of North Carolina at Chapel Hill.
Primary purpose: PREVENTION

Brief summary: Experts note that in order to continue reducing the US cancer burden, it is critical that investigators "more completely apply discoveries in cancer prevention we have already made." Thus, it is important to research strategies that aim to improve application of effective colorectal cancer (CRC) prevention and screening tests among underserved populations like American Indians (AI).CRC is the 2nd leading cause of cancer death among AI; yet, one of the most preventable and treatable cancers when detected early. Increased use of recommended CRC screening tests among men and women ages 50-75 have contributed to nearly 50% declines in US CRC mortality since 1990. However, recent evidence indicates AI have not observed equitable improvements. The investigators propose to build upon our experience addressing CRC screening in underserved populations and strong partnerships with North Carolina tribal partners to gain new insight about a patient-centered, culturally appropriate strategy to increase AI CRC screening.

Detailed description: Colorectal Cancer (CRC) Screening Options. CRC is a unique cancer due to the multiple screening options including stool-based (fecal occult blood testing (FOBT) and fecal immunochemical testing (FIT)), and direct visualization (colonoscopy) options. Healthcare providers tend to recommend colonoscopy, although evidence indicates that many patients, especially low-income and racial and ethnic minorities, prefer stool-based testing for a variety of reasons. In our formative work with North Carolina tribes, the investigators found evidence of low awareness of stool-based tests among American Indians (AI) and healthcare provider preferences to recommend colonoscopy. The US Preventive Services Task Force (USPSTF) guidelines indicate that evidence does not support favoring one CRC screening test above the others, and that recommendations should be based on patient preferences among the screening options. However, patient's general lack of knowledge of CRC screening modalities, literacy barriers to understanding differences between options, and other communication barriers in the healthcare setting (e.g., limited physician time) make this recommendation difficult to implement in practice without appropriate tools and support. Multimedia decision aids provide a practical solution to overcome communication challenges by providing patients information using easy-to-understand graphics and narratives designed to help them understand options, think through what is important to them, and engage with healthcare providers and family in the decision-making process.

CRC Screening Decision Aids. A recent systematic review and meta-analysis found evidence that average risk patients (aged 50 and over) exposed to CRC screening decisions aids showed greater increases in knowledge, were more likely to be interested in getting screened, and more likely to be screened. Most research on decision aids has been conduct with majority White populations; a few studies have focused on patients with low socioeconomic status. To our knowledge, no CRC screening decision aid studies have focused on AI populations.Our team has expertise in adapting CRC screening decision aids for underserved populations. The investigators have used a rigorous, community- and patient-engaged process to adapt a decision aid previously shown to be effective among majority White populations. The process retains effective elements of the existing version and refines content using messages and messengers that are culturally-sensitive (beyond peripheral packaging of graphics and visual content). A version the investigators adapted for low-income Hispanics significantly improved Hispanic patient's CRC screening knowledge, patient-provider communication, self-efficacy, and intent, and when combined with navigation, significantly improved completion of screening.

AI Barriers to CRC Screening. AI may benefit from decision aids; yet, CRC screening decision aids have not been developed or tested with AI populations. Several studies have found that AI have lower awareness and knowledge about CRC screening options and low perceived susceptibility of CRC than White populations. Many qualitative studies also indicate social and cultural barriers to CRC screening. For example, AIs indicate taboos related to speaking of illness or of certain body parts and fatalistic cultural beliefs influence their attitudes and intentions to obtain preventive medical services. In addition, a history of unethical healthcare practices and mistreatment of AI by the US government has led to issues of mistrust. Recent studies have found that AI report negative perceptions of medical providers and mistrust in healthcare institutions as barriers to obtaining CRC screening. Decision aids can address low awareness of options and improve attitudes and intentions for screening, especially if the content and the messengers of the information are adapted for sensitivity to relevant socio-cultural barriers (e.g., spiritual advisors who are credible to AI endorse screening). For this proposal, the investigators propose to test a novel culturally-adapted decision aid that aims to improve knowledge, attitudes and intentions to obtain CRC screening and uses messaging developed with our tribal community partners to overcome health literacy and socio-cultural barriers.

Conceptual Framework. Our decision aid is informed by the Theory of Planned Behavior and Cultural Identity Theory. The Theory of Planned Behavior posits that individual's attitudes (i.e., how one feels about a behavior and the potential outcomes of the behavior), norms (i.e., the amount of social pressure one feels to perform a behavior), and agency (i.e., the extent that one feels in control and able to perform a behavior) impacts their intentions to and subsequent performance of a behavior. The investigators also draw upon Cultural Identity Theory and posit that one's cultural identity and corresponding values underlie how one receives and interprets communicated messages and how one communicates with others about these messages. Our culturally-adapted decision aid uses messages that address AI-specific attitudes, norms, agency and communication concerns.

Preliminary Studies. With developmental funding from UNC's Lineberger Comprehensive Cancer Center, the investigators followed a rigorous process to adapt a general population version of a CRC screening decision aid for AI. From January to May of 2016, the investigators conducted six focus groups (n=74) with AI (ages 50-75) and interviews with healthcare providers (n=8) from three North Carolina tribal communities. The investigators explored perspectives about cultural, communication, and literacy barriers to CRC screening, and identified critical themes regarding AI cultural identity and socio-cultural values that influence CRC screening. The investigators and our tribal partners have operationalized the themes into adaptations of the existing general population decision aid. The decision aid provides information on stool-based and colonoscopy tests, the two types readily available in the community. The investigators are filming and making edits to the decision aid, which will be completed and ready for pilot testing by December 2016. Themes from AI focus groups and operationalized changes to a culturally-adapted CRC screening decision aid Operationalized Changes Healthcare mistrust - concern that inappropriate medical tests are recommended by providers Religious advisor to provide information and conveys trust in CRC screening options AI collectivism - stronger 'family' and community orientation toward health than individual focus New messages emphasize the benefit of CRC screening to one's family and community Privacy concerns- indication of difficulties and discomfort talking about CRC screening with family Vignette that models family communication around CRC screening Fear of cancer and screening - fear of cancer and screening process reduces motivation for screening AI CRC survivor to share experience of being screened and treated early

Methods A. Setting Our current research is centered in North Carolina tribal communities, primarily with the Lumbee Tribe of North Carolina, a state-recognized tribe that is located in Southeastern North Carolina. There are 62,306 Lumbee tribal members, the majority of whom (48,494) live in Robeson county. As with AI populations across the US, North Carolina AI have high rates of poverty and low educational attainment. One-third (33%) of AI in Robeson County are below the federal poverty level compared to 17% in North Carolina overall.45As a state-recognized tribe, Lumbee are not eligible for services through the federally-funded Indian Health Service,44 and many Lumbee tribal members use safety-net and federally qualified health centers such as the Robeson Health Care Corporation (RHCC), partner on this grant (see letter of support) to obtain health services.Robeson Health Care Corporation is a federally qualified health center with six clinics located in Robeson and neighboring counties. RHCC serves over 14,000 patients per year; 40% are AI. Nearly all, 95.6% of RHCC patients are at or below 200% of the federal poverty line. According to recent reports, 6,295 RHHC patients were not up-to-date with CRC screening following recommended guidelines.RHHC also has a long history of research collaboration on cancer screening projects.

Eligibility criteria: Inclusion Criteria:

* Aged 50-75
* Self-identify as AI (from any tribe)
* Are not up-to-date with recommended screening in accordance with USPSTF guidelines.

Exclusion Criteria:

* Patients who have a personal or family history of CRC or adenomatous polyps or inherited genetic conditions that increase CRC risk (familial adenomatous polyposis, Lynch syndrome, Turcot syndrome, Peutz-Jeghers syndrome, or MUTYH-associated polyposis)
* Unable to speak English
* Severe cognitive, visual, or hearing impairment that would prevent decision aid viewing.

Primary outcomes:
measure: CRC screening intentions
timeFrame: Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.
Secondary outcomes:
measure: Knowledge
timeFrame: Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.
measure: Attitudes
timeFrame: Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.
measure: Perceived social norms
timeFrame: Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.
measure: Personal agency
timeFrame: Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.
measure: CRC screening preferences
timeFrame: Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.
measure: Healthcare provider communication
timeFrame: Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.
measure: Family and friend communication
timeFrame: Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.
measure: CRC screening completion
timeFrame: Immediately after participant views their respective assigned video. Five (5) months following the encounter, a research assistant will call and administer a follow-up survey.
Other outcomes:
Locations:
city: Lumberton
country: United States
facility: Robeson Health Care Corporation
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Leah Frerichs, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Frerichs L, Beasley C, Pevia K, Lowery J, Ferrari R, Bell R, Reuland D. Testing a Culturally Adapted Colorectal Cancer Screening Decision Aid Among American Indians: Results from a Pre-Post Trial. Health Equity. 2020 Apr 1;4(1):91-98. doi: 10.1089/heq.2019.0095. eCollection 2020.