The Clinical Application of Refined Risk Estimates (caRe) Study in BRCA1 and BRCA2 Pathogenic Variant Carriers: A Randomized Controlled Trial

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.

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Publication Details

Journal
Cancer Prevention Research
Published
2026-06-24
DOI
https://doi.org/10.1158/1940-6207.capr-26-0044
Primary Topic
BRCA gene mutations in cancer
Type
article
Field-Weighted Citation Impact
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article

The Clinical Application of Refined Risk Estimates (caRe) Study in BRCA1 and BRCA2 Pathogenic Variant Carriers: A Randomized Controlled Trial

Julie Mak, Whitney Espinel, Erika L. Spaeth, Darcy L. Thull et al.
Cancer Prevention Research
BRCA gene mutations in cancer
article

The Clinical Application of Refined Risk Estimates (caRe) Study in BRCA1 and BRCA2 Pathogenic Variant Carriers: A Randomized Controlled Trial

Julie Mak, Whitney Espinel, Erika L. Spaeth, Darcy L. Thull, Leigha Senter, Rachel M. Smith, Guy Brock, Doreen M. Agnese, Ava Willoughby, Pyatt Rs, Amanda Ewart Toland, Norden Lc, Sarah V. Colonna, Wendy K. Kohlmann, Amy Webb, Allison DePersia, Shelly Renee Anstey Hovick, Rachel Notestine, Nadia Benny, Ora Gordon, Shannon Phillips
article en

Abstract

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.

Cancer Prevention Research
Heart Rhythm Society (US), Nationwide Children's Hospital (US), NorthShore University HealthSystem (US), Huntsman (United States) (US), University of Pittsburgh (US), The Ohio State University Comprehensive Cancer Center – Arthur G. James Cancer Hospital and Richard J. Solove Research Institute (US), Huntsman Cancer Institute (US), The Ohio State University Wexner Medical Center (US), UCSF Helen Diller Family Comprehensive Cancer Center (US), The Ohio State University (US), Providence Health & Services (US)
Peace, Justice and strong institutions
Openalex Percentile: Top 7%
BRCA gene mutations in cancer
DOISourceOpenAlex
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