A Culturally-adapted Colorectal Cancer Screening Decision Aid Designed for American Indians
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Colorectal Cancer Screening Decision Aid; Control Group
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Information previously discussed in arm/group descriptions. There will be baseline, post-encounter, and 5-month follow-up assessments.; Information previously discussed in arm/group descriptions. There will be baseline, post-encounter, and 5-month follow-up assessments. Information previously discussed in arm/group descriptions. There will be baseline, post-encounter, and 5-month follow-up assessments.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: colorectal cancer screening; decision aids; American Indians