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

Abstract

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 telephone-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 multilevel 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.

Figure 1.

GRACE study CONSORT diagram. In the intent-to-treat analysis, only participants found ineligible after random assignment were excluded. GRACE = Genetic Risk Assessment for Cancer Education and Empowerment; GC/GT = genetic counseling and/or testing; MRV = medical record verified; TCN = tailored counseling and navigation; TP = targeted print.

Figure 2.

Cumulative incidence based on Kaplan-Meier estimates of CGRA uptake after intervention and 95% confidence intervals. CGRA = cancer genetic risk assessment (genetic counseling and/or testing); TCN = tailored counseling and navigation; TP = targeted print; UC = usual care.