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）