Comparative Effectiveness of Interventions to Increase Guideline-based Genetic Counseling in Ethnically and Geographically Diverse Cancer Survivors

针对不同种族和地域的癌症幸存者增加基于指南的遗传咨询的干预措施的比较有效性

• 批准号: 9215545
• 负责人: Anita Y. Kinney
• 金额: $ 62.92万
• 依托单位: UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-12-22 至 2021-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9215545
• 关键词: Address; Adherence; Adoption; Affective; Age; Attitude; Awareness; BRCA1 gene; BRCA2 gene; Belief; Breast; Cancer Center; Cancer Etiology; Cancer Survivor; Caring; Cognitive; Colorado; Communication; Conflict (Psychology); Counseling; Data; Decision Making; Diagnosis; Disease; Distress; Early Diagnosis; Effectiveness of Interventions; Enrollment; Ensure; Ethnic Origin; Excision; Family; Family member; Female; Fright; Generic Drugs; Genes; Genetic Counseling; Genetic Services; Genetic screening method; Genomics; Geography; Goals; Guidelines; Health; Health Personnel; Healthcare; Hereditary Breast Carcinoma; High Risk Woman; High-Risk Cancer; Hispanics; Improve Access; Individual; Individual Differences; Intervention; Intervention Studies; Knowledge; Life; Malignant Neoplasms; Malignant neoplasm of ovary; Measures; Mediating; Medical Genetics; Morbidity - disease rate; Motivation; Mutation; New Mexico; Not Hispanic or Latino; Outcome; Ovarian; Participant; Persons; Policy Maker; Population; Population Heterogeneity; Process; Provider; Public Health; Randomized; Randomized Controlled Trials; Recommendation; Recruitment Activity; Registries; Regrets; Risk; Risk Assessment; Risk Reduction; Rural; Savings; Second Primary Cancers; Services; Specific qualifier value; Stress; Surveys; System; Telephone; Testing; Translations; Uncertainty; Underserved Population; Woman; Work; arm; base; behavior change; cancer care; cancer education; cancer genetics; cancer health disparity; cancer prevention; cancer risk; care delivery; clinical practice; comparative effectiveness; compare effectiveness; cost; cost effectiveness; demographics; disparity reduction; economic evaluation; empowerment; evidence base; follow-up; genetic risk assessment; health disparity; health literacy; high risk; improved; innovation; intervention effect; lifestyle factors; malignant breast neoplasm; medically underserved; medically underserved population; mortality disparity; neoplasm registry; peritoneal cancer; precision medicine; preference; prevent; primary outcome; public health intervention; randomized trial; rural dwellers; social; successful intervention; survivorship; telehealth; three-arm study; treatment as usual; uptake

Genetic counseling or Cancer Genetic Risk Assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) is an evidence-based precision medicine strategy that facilitates informed decision making about effective health management options. Identification of individuals at increased risk of HBOC is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, treatment and survivorship. Although national guidelines for CGRA and genetic testing have been available for two decades, only one-third or less of high-risk women have accessed these services. The optimal risk assessment strategy starts with an individual with an HBOC-related cancer. Widespread dissemination and adoption of national guidelines for informed decision-making and promoting CGRA is needed to achieve a population-level reduction in cancer morbidity, mortality and disparities. Thus, it is important to promote access to CGRA, particularly in medically underserved populations. The proposed Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project seeks to address this important translational gap by developing and implementing strategies to promote guideline-based care in the Rocky Mountain region where there are distinguishable disparities in CGRA utilization by ethnicity and geography. Remarkably, few intervention studies have been conducted to address the regional and national translational gap in CGRA utilization for these diverse populations, underscoring our study's high impact and innovative public health intervention delivery approach. The GRACE Project is guided by evidenced-based behavior change counseling strategies to promote risk-based care delivery and reduce disparities that consider individual, cultural, social and system-level factors. The study's primary aim is to test the comparative effectiveness of mailed targeted print (TP) vs. TP plus a telephone-based tailored counseling and navigation intervention (TCN) vs. usual care (UC) to increase guideline-based CGRA for HBOC. We will oversample Hispanics and rural dwellers and enroll 1206 high-risk female cancer survivors. Women will be recruited through the Colorado and New Mexico cancer registries and meet the criteria for a CGRA referral. Enrollees will be randomized to one of 3 study arms and complete baseline, 1-month, 6-month and 12-month surveys. Specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored (TPC) intervention vs. usual care (UC) on CGRA utilization 6 months (primary outcome) after the intervention and at 12 months, after removal of key access barriers; 2) compare the effectiveness of the interventions on genetic testing utilization; 3) examine potential underlying theoretical mediating and moderating mechanisms that will further specify and elucidate significant intervention effects; and 4) compare the cost effectiveness of the interventions vs. usual care, for utilization of CGRA services. If effective, either or both interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination.

遗传性乳腺癌和卵巢癌的遗传咨询或癌症遗传风险评估（CGRA） （HBOC）是一种基于证据的精准医疗策略，有助于做出明智的决策， 有效的健康管理方案。识别HBOC风险增加的个体至关重要， 癌症幸存者及其家人受益于癌症预防，早期发现， 治疗和生存。虽然CGRA和基因检测的国家指导方针已经出台， 20年来，只有三分之一或更少的高危妇女获得了这些服务。最优风险 评估策略从患有HBOC相关癌症的个体开始。广泛传播和 需要通过国家指导方针进行知情决策和促进CGRA，以实现 在人口一级减少癌症发病率、死亡率和差距。因此，必须促进获得 尤其是在医疗服务不足的人群中。拟议的遗传风险评估， 癌症教育和赋权（GRACE）项目旨在通过以下方式解决这一重要的翻译差距： 制定和实施战略，以促进落基山脉地区以指导为基础的护理， 在CGRA的使用方面，种族和地理位置存在明显的差异。值得注意的是， 已经进行了干预研究，以解决CGRA的区域和国家翻译差距 利用这些不同的人群，强调我们的研究的高影响力和创新的公共卫生 干预提供方法。GRACE项目以循证行为改变咨询为指导 制定战略，促进基于风险的护理服务，减少考虑到个人、文化、社会 系统层面的因素。这项研究的主要目的是测试邮寄目标的比较有效性 打印（TP）与TP+基于电话的定制咨询和导航干预（TCN）与常规护理 (UC)增加基于指南的HBOC CGRA。我们将对拉美裔和农村居民进行过度抽样， 1206名高危女性癌症幸存者。女性将通过科罗拉多和新墨西哥州癌症招募 注册并符合CGRA转介标准。入组者将被随机分配至3个研究组之一， 完成基线、1个月、6个月和12个月调查。具体目标是：1）比较 针对性干预（TP）与定制干预（TPC）与常规护理（UC）对CGRA的有效性 干预后6个月（主要结局）和移除关键通路后12个月时的利用率 障碍; 2）比较基因检测利用干预措施的有效性; 3）检查潜在的 潜在的理论中介和调节机制，将进一步详细说明和阐明重要的 干预效果; 4）比较干预与常规护理的成本效益， CGRA服务。如果有效，其中一种或两种干预措施都有可能接触到大量高风险人群。 通过广泛传播，减少不平等。