American BRCA Outcomes and Utilization of Testing (ABOUT) Study: A Pragmatic Research Model that Incorporates Personalized Medicine/Patient-Centered Outcomes in a Real World Setting
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Research to date regarding identification and management of hereditary breast and ovarian cancer syndrome (HBOC) in the U.S. has been confined primarily to academic center-based studies with limited patient engagement. To begin to understand and address the current gaps and disparities in delivery of services for the appropriate identification and optimal risk management of individuals with HBOC, we designed and have initiated the American BRCA Outcomes and Utilization of Testing (ABOUT) Study. ABOUT relies on a collaborative patient advocacy, academic and industry partnership to recruit and engage U.S. individuals who are at increased risk for HBOC and investigate their experiences, decisions and outcomes. It utilizes an extensive research infrastructure, including an interactive web-based data system and electronic interfaces for secure online participation and automated data exchange. We describe the novel recruitment approach that was designed for collaboration with a national commercial health plan partner to identify all individuals for whom a healthcare provider orders a BRCA test and mail to each individual an invitation to participate and study packet. The study packet contains detailed information about the study, a baseline questionnaire and informed consent for participation in the study, for release of relevant medical and health plan records and for ongoing research engagement. This approach employs patient-reported, laboratory-reported and health plan-reported outcomes and facilitates longitudinal engagement. We believe that the type of innovative methodology and collaborative framework we have developed for ABOUT is an ideal foundation for a patient-powered research network. This approach can make substantial contributions to identifying current and best practices in HBOC, leading to improved strategies for clinical care and optimal health outcomes among individuals with high inherited risk for cancer.
KeywordsHereditary breast and ovarian cancer (HBOC) BRCA1 BRCA2 BRCA Genetic testing Breast cancer Ovarian cancer
This research was supported with funds received through the Aetna Foundation as well as in-kind support from Aetna, USF, FORCE, ACS, Georgetown University Lombardi Comprehensive Cancer Center, and Emory University Rollins School of Public Health. We would like to thank Deb Duquette and Sarah Mange, from the Michigan Department of Community Health Cancer Genomics Program (MI DCHCGP), and Elizabeth Bourquardez Clark, from USF, for contributing to the review and refinement of this manuscript; Rose Bishop Kovatch, Jana Pruski-Clark, Vilia Corvizon, Jenna McLosky, Beth E. Anderson and Deb Duquette for contributing to the review and refinement of the ABOUT baseline and follow-up questionnaires prior to dissemination; USF undergraduate students who performed systems testing for data entry, checking and cleaning : Ethan Arrington, Chenin Blanco, Dominic Bracero, Bridget Budny, Mitchell Darnell, Barbara DaVilla, Amanda DeRenzis, Bradley Fagerberg, Nicole Fernung, Dana Hobi, Paul Johannes, Sherrie Leon, Pedro Limas, Hannah McGrew, Danielle Melton, Jude Nawlo, Kaajal Patel, Niral A. Patel, Andrianna Santos, Tyler Schaefer, Puja Shah, Jhulianna Vivar, Adam Weaver, and Andreas Zacharopoulos; and especially Aetna members who agreed to participate in the study.
Conflict of Interest
Dr. Sutphen is the President and Chief Medical Officer of a national telephone genetic counseling provider organization, Informed Medical Decisions, Inc.
Joanne Armstrong, Michele Toscano, Nancy Kotchko, Sue Friedman, Marc D. Schwartz, Katherine S. Virgo, Kristian Lynch, James E. Andrews, Claudia X. Aguado Loi, Joseph E. Bauer, Carolina Casares, Rachel Threet Teten, Matthew R. Kondoff, Ashley D. Molina, Mehrnaz Abdollahian, Lana Brand, and Gregory S. Walker declare that they have no conflict of interest.
Human Studies and Informed Consent
All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). Informed consent was obtained from all patients for being included in the study.
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