The Clinical Application of Refined Risk Estimates (caRe) Study in BRCA1 and BRCA2 Pathogenic Variant Carriers: A Randomized Controlled Trial
Leigha Senter, Shelly Hovick, Rachel Notestine, Lauren Norden, Nadia Benny, Shannon Phillips, Ava Willoughby, Robert Pyatt, Doreen Agnese, Julie S. Mak, Allison DePersia, Sarah V. Colonna, Whitney F. Maxwell, Wendy Kohlmann, Erika L. Spaeth, Ora Gordon, Darcy Thull, Guy N. Brock, Amy Webb, Rachel M. Smith, Amanda Ewart. TolandAbstract
Individuals with germline BRCA1 or BRCA2 pathogenic variants (PVs) may struggle with risk management decision-making. Advancements in technology could provide more specific risk information to patients, but the impact of this information is unknown. The Clinical Application of Refined Risk Estimates Study is a two-arm randomized controlled trial in women with a BRCA1/BRCA2 PV. The primary objective was to determine whether genotype-informed cancer risk estimates (GRE) compared to standard lifetime cancer risk estimates (SRE) decreased decisional conflict related to cancer risk management decision-making. Women were recruited following disclosure of their PV results. Participants completed a baseline survey and were randomized 1:1 to receive a GRE or SRE. After receiving their results, participants completed a follow-up survey. Likert and continuous data measures were analyzed using linear regression. There were no differences in decisional conflict between study arms at follow-up. However, individuals in the SRE arm showed an increased need for personal structure compared to those in the GRE arm (p =0.02). Compared to baseline, individuals within the SRE arm showed decreased decisional conflict (p =0.003) and increased perceived stress (p =0.02) at follow-up. A more personalized cancer risk estimate did not decrease decisional conflict in women with BRCA1/BRCA2 PVs. Future studies will determine whether a GRE impacts actual decision-making behaviors.