Enhancing Prevention Pathways Toward Tribal Colorectal Health
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,788
- 试验地点
- 2
- 主要终点
- Annual Completion of the FIT Kit
研究概览
简要总结
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 45-75 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 45-75. 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.
详细描述
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 45-75, 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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •AIs at average-risk for CRC,
- •Not "up to date" with US Preventive Services Task Force (USPSTF) CRC screening guidelines (i.e., no guaiac fecal occult blood test [FOBT] or FIT in past year; no flexible sigmoidoscopy in past 5 years; no colonoscopy in past 10 years), and
- •Residing in one of the six Pueblo Tribes participating in the research.
排除标准
- •meeting at least one of the following criteria:
- •History of CRC, total colectomy, adenomatous polyps, or history of inflammatory bowel disease,
- •Up-to-date with CRC screening,
- •Severe comorbidity,
- •No visit to IHS facilities in the past three years,
- •Incarceration,
- •Family history of CRC, or
- •Hospice/terminal care status.
- •C. Aim 2--Qualitative Research (Understanding Behavior Change Context)
- •Inclusion Criteria:
- •Participants who completed a FIT (Aim 1),
- •Participants who did not complete a FIT (Aim 1),
- •Navigators participating in the high intensity interventions (Aim 1),
- •Health care providers and medical directors of the IHS facilities participating in the study.
- •Exclusion Criteria:
结局指标
主要结局
Annual Completion of the FIT Kit
时间窗: The interventions are delivered over 3 12-month cycles. The primary outcome will be measured within 3 12-month periods. Cycle 1: T1-T12 months; Cycle 2: T13-T24 months; Cycle 3: T25-T36 months
次要结局
- Change in Attitudes(Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months))
- Change in Perceived Susceptibility(Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months))
- Change in Self-Efficacy(Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months))
- Change in Perceived Severity(Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months))
- Change in Knowledge(Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months))
- Change in Perceived Control(Baseline (T0 month), Posttest 1 (T1-T12 months), Posttest 2 (T13-T24 months), Posttest 3 (T25-T36 months))
研究者
Shiraz I Mishra
Professor
University of New Mexico