Randomized trial promoting cancer genetic risk assessment when genetic counseling cost removed: 1-year follow-up.

PURPOSE: Cancer Genetic Risk Assessment (CGRA) is recommended for women with ovarian and high-risk breast cancer. However, the underutilization of CGRA has long been documented, and cost has been a major barrier. In this randomized controlled trial, a Tailored Counseling and Navigation (TCN) intervention significantly improved CGRA uptake at 6-month follow-up, compared with Targeted Print (TP) and Usual Care (UC). We aimed to examine the effect of removing genetic counseling costs on CGRA uptake by 12 months.

METHODS: We recruited racially and geographically diverse women with breast and ovarian cancer from cancer registries in Colorado, New Jersey, and New Mexico. Participants assigned to TCN received phone-based psychoeducation and navigation. After 6 months, the trial provided free genetic counseling to participants in all arms.

RESULTS: At 12 months, more women in TCN obtained CGRA (26.6%) than those in TP (11.0%, Odds ratio (OR) = 2.77, 95% Confidence interval (CI) 1.56 to 4.89) and UC (12.2%, OR = 2.46, 95% CI 1.41 to 4.29). There were no significant differences in CGRA uptake between TP and UC. The Kaplan-Meier curve shows that the divergence of cumulative incidence slopes (TCN vs UC, TCN vs TP) appears primarily within the initial 6 months.

CONCLUSION: TCN significantly increased CGRA uptake at the 12-month follow-up. Directly removing the costs of genetic counseling attenuated the effects of TCN, highlighting the critical enabling role played by cost coverage. Future policies and interventions should address multi-level cost-related barriers to expand patients' access to CGRA.

TRIAL REGISTRATION: This trial was registered with the NIH clinical trial registry, clinicaltrials.gov, NCT03326713. https://clinicaltrials.gov/ct2/show/NCT03326713.