Understanding Cancer Genetic Risk Assessment Intentions in a Tailored Risk Communication Intervention Randomized Controlled Trial

Abstract

Background: Pathogenic variants in cancer predisposition genes increase second, hereditary cancer risk among women with breast and/or ovarian cancer, and primary cancers in their relatives. National guidelines recommend cancer genetic risk assessment (CGRA) (genetic counseling and/or genetic testing) for women at increased hereditary breast and ovarian cancer (HBOC) risk. Yet, less than half of high risk women, including rural dwellers and racial minorities have accessed CGRA. Purpose: The Genetic Risk Assessment for Cancer Education and Empowerment Project (GRACE), a superiority trial, addressed this translational gap, testing the efficacy of a targeted print brochure (TP) vs tailored counseling and navigation (TCN) vs usual care (UC) on CGRA intentions. TCN targeted behavioral variables theorized to mediate CGRA intentions. We believe GRACE is the first study of its kind promoting guideline-based CGRA to women at increased HBOC risk. Methods: CGRA-eligible women were recruited from three state cancer registries (N=641), completed a baseline survey, and randomized to TCN, TP or UC. TP and TCN received the mailed educational brochure. TCN also engaged in a telephone-based decision coaching and navigation session using motivational interviewing and tailored materials based on the Extended Parallel Process Model and Health Action Process Approach. Participants completed a follow-up survey at one month. Results: TCN improved CGRA intentions compared to TP (0.64, p<0.001, CI 0.32, 0.97) and UC (0.69, p<0.001, CI 0.37, 1.02). Theoretical targets, perceived risk (0.77, p=0.02, CI 0.11, 1.44) and self-efficacy (0.67, p=0.04, CI 0.05, 1.28) mediated CGRA intentions in TCN. Stratification showed increases in CGRA intentions for TCN vs TP among non-Hispanic Whites, Hispanics, urban dwellers, and women with low health literacy and no family history of breast and/or ovarian cancer (FBOC). In TCN, perceived self-efficacy improved in women with no FBOC. Conclusions: Improvements in CGRA intentions and theorized mediators support use of tailored risk communication interventions in Hispanics and women with low health literacy and no FBOC. Further tailoring may improve CGRA intentions in Blacks, other minorities, rural dwellers, and women with high health literacy and FBOC.