Anita Y Kinney1, Rachel Howell2, Rachel Ruckman2, Jean A McDougall3, Tawny W Boyce2, Belinda Vicuña4, Ji-Hyun Lee3, Dolores D Guest2, Randi Rycroft5, Patricia A Valverde6, Kristina M Gallegos2, Angela Meisner7, Charles L Wiggins8, Antoinette Stroup9, Lisa E Paddock9, Scott T Walters10. 1. Department of Epidemiology, School of Public Health, Rutgers University, New Brunswick, Jersey; Cancer Institute of New Jersey, Rutgers University, New Brunswick, Jersey. Electronic address: anita.kinney@rutgers.edu. 2. Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico. 3. Department of Internal Medicine, University of New Mexico, Albuquerque, Mexico; Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico. 4. Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico; Department of Psychology, University of New Mexico, Albuquerque, Mexico. 5. Colorado Central Cancer Registry, Colorado Department of Public Health and Environment, Denver, CO, United States. 6. Colorado School of Public Health, University of Colorado, Aurora, CO, United States. 7. New Mexico Tumor Registry, University of New Mexico, Albuquerque, Mexico. 8. Department of Internal Medicine, University of New Mexico, Albuquerque, Mexico; Comprehensive Cancer Center, University of New Mexico, Albuquerque, Mexico; New Mexico Tumor Registry, University of New Mexico, Albuquerque, Mexico. 9. Department of Epidemiology, School of Public Health, Rutgers University, New Brunswick, Jersey; Cancer Institute of New Jersey, Rutgers University, New Brunswick, Jersey. 10. Department of Health Behavior and Health Systems, University of North Texas Health Science Center, School of Public Health, Fort Worth, TX, United States.
Abstract
BACKGROUND: Although national guidelines for cancer genetic risk assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) have been available for over two decades, less than half of high-risk women have accessed these services, especially underserved minority and rural populations. Identification of high-risk individuals is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, and treatment. METHODS: This paper describes community-engaged formative research and the protocol of the ongoing randomized 3-arm controlled Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) trial. Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries. The specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored counseling and navigation(TCN) intervention vs. usual care (UC) on CGRA utilization at 6 months post-diagnosis (primary outcome); compare the effectiveness of the interventions on genetic counseling uptake at 12 months after removal of cost barriers (secondary outcome); 2) examine potential underlying theoretical mediating and moderating mechanisms; and 3) conduct a cost evaluation to guide dissemination strategies. DISCUSSION: The ongoing GRACE trial addresses an important translational gap by developing and implementing evidence-based strategies to promote guideline-based care and reduce disparities in CGRA utilization among ethnically and geographically diverse women. If effective, these interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination. TRIAL REGISTRATION NUMBER: NCT03326713; clinicaltrials.gov.
RCT Entities:
BACKGROUND: Although national guidelines for cancer genetic risk assessment (CGRA) for hereditary breast and ovarian cancer (HBOC) have been available for over two decades, less than half of high-risk women have accessed these services, especially underserved minority and rural populations. Identification of high-risk individuals is crucial for cancer survivors and their families to benefit from biomedical advances in cancer prevention, early detection, and treatment. METHODS: This paper describes community-engaged formative research and the protocol of the ongoing randomized 3-arm controlled Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) trial. Ethnically and geographically diverse breast and ovarian cancer survivors at increased risk for hereditary cancer predisposition who have not had a CGRA are recruited through the three statewide cancer registries. The specific aims are to: 1) compare the effectiveness of a targeted intervention (TP) vs. a tailored counseling and navigation(TCN) intervention vs. usual care (UC) on CGRA utilization at 6 months post-diagnosis (primary outcome); compare the effectiveness of the interventions on genetic counseling uptake at 12 months after removal of cost barriers (secondary outcome); 2) examine potential underlying theoretical mediating and moderating mechanisms; and 3) conduct a cost evaluation to guide dissemination strategies. DISCUSSION: The ongoing GRACE trial addresses an important translational gap by developing and implementing evidence-based strategies to promote guideline-based care and reduce disparities in CGRA utilization among ethnically and geographically diverse women. If effective, these interventions have the potential to reach a large number of high-risk families and reduce disparities through broad dissemination. TRIAL REGISTRATION NUMBER: NCT03326713; clinicaltrials.gov.
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