@article{c1913970982e45ebb363b9a86a34f78c,
title = "Promoting guideline-based cancer genetic risk assessment for hereditary breast and ovarian cancer in ethnically and geographically diverse cancer survivors: Rationale and design of a 3-arm randomized controlled trial",
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.",
keywords = "Assessment risk, Genetic counseling, Hereditary cancer",
author = "Kinney, {Anita Y.} and Rachel Howell and Rachel Ruckman and McDougall, {Jean A.} and Boyce, {Tawny W.} and Belinda Vicu{\~n}a and Lee, {Ji Hyun} and Guest, {Dolores D.} and Randi Rycroft and Valverde, {Patricia A.} and Gallegos, {Kristina M.} and Angela Meisner and Wiggins, {Charles L.} and Antoinette Stroup and Paddock, {Lisa E.} and Walters, {Scott T.}",
note = "Funding Information: This work is supported by the National Cancer Institute of the National Institutes of Health [ R01CA211625 to A.Y·K] and the UNM Comprehensive Cancer Center core grant from the National Cancer Institute [ NIH/NCI 3 P30 CA118100 ], including use of the services provided by the Behavioral Measurement and Population Sciences (BMPS) and Biostatistics Shared Resources. Support is also provided by the New Mexico Tumor Registry , Contract No. HHSN261201800014I , Task Order HHSN26100001 from the National Cancer Institute . Support is also provided by the Cancer Institute of New Jersey , Contract No. HHSN261201300101 , Task Order HHSN26100005 and HHSN26120130002 from the National Cancer Institute , and Cooperative Agreement # NU58DP006347-02 from the Centers for Disease Control . Funding Information: This work is supported by the National Cancer Institute of the National Institutes of Health [R01CA211625 to A.Y·K] and the UNM Comprehensive Cancer Center core grant from the National Cancer Institute [NIH/NCI 3 P30 CA118100], including use of the services provided by the Behavioral Measurement and Population Sciences (BMPS) and Biostatistics Shared Resources. Support is also provided by the New Mexico Tumor Registry, Contract No. HHSN261201800014I, Task Order HHSN26100001 from the National Cancer Institute. Support is also provided by the Cancer Institute of New Jersey, Contract No. HHSN261201300101, Task Order HHSN26100005 and HHSN26120130002 from the National Cancer Institute, and Cooperative Agreement #NU58DP006347-02 from the Centers for Disease Control. Publisher Copyright: {\textcopyright} 2018 Elsevier Inc.",
year = "2018",
month = oct,
doi = "10.1016/j.cct.2018.09.005",
language = "English",
volume = "73",
pages = "123--135",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",
}