Jinghua An

Cost-Effectiveness of Remote Tailored Risk Communication and Navigation for Hereditary Genetic Risk Assessment Uptake: Economic Evaluation From the Genetic Risk Assessment for Cancer Education and Empowerment Trial

PURPOSE The Genetic Risk Assessment for Cancer Education and Empowerment Project demonstrated that tailored counseling and navigation (TCN) substantially increased the rate of genetic evaluation (GE) in women with high-risk breast or ovarian cancer (odds ratio, 8.9 [95% CI, 3.4 to 23.5] for TCN v usual care [UC]). This study sought to estimate the cost and cost-effectiveness of TCN in a clinic setting from a societal perspective. METHODS We identified the components of the intervention and downstream outcomes which would result in resource use. We assessed time spent by staff, cost of mailings, cost of patient time, and cost of testing and counseling in 6 months. Incremental cost-effectiveness ratios were calculated for outcomes of interest. We assessed the sensitivity of our results to assumptions via one-way sensitivity analyses. In addition, we assessed how results would change if a higher volume of patients was given TCN, with a health coach working full-time. RESULTS TCN costs $68,924 in US dollars (USD) to deliver per 212 patients, or $325 USD per patient. The intervention cost was $2,154 USD per record-verified GE. Much of this was attributed to training costs for health coaches ($50,223 USD). When including testing and counseling, the incremental cost effectiveness ratio (ICER) of TCN versus UC was $3,250 USD per additional GE. This was most sensitive to TCN effectiveness (ie, GE rate in TCN patients) and cost of testing. Cost-effectiveness would be more favorable with higher coaching volume (ICER of $1,730 USD/GE). CONCLUSION Implementing TCN in a clinic setting would come with notable costs, and current reimbursement policies for telemedicine may not be sufficient. Cost-effectiveness of TCN can be improved if subsequent interventions are more efficacious or are delivered to greater patient volumes.

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.

Identifying Mediators of Intervention Effects Within a Randomized Controlled Trial to Motivate Cancer Genetic Risk Assessment Among Breast and Ovarian Cancer Survivors

Abstract Background A theory-guided Tailored Counseling and Navigation (TCN) intervention successfully increased cancer genetic risk assessment (CGRA) uptake among cancer survivors at increased risk of hereditary breast and ovarian cancer (HBOC). Understanding the pathways by which interventions motivate behavior change is important for identifying the intervention’s active components. Purpose We examined whether the TCN intervention exerted effects on CGRA uptake through hypothesized theoretical mediators. Methods Cancer survivors at elevated risk for HBOC were recruited from three statewide cancer registries and were randomly assigned to three arms: TCN (n = 212), Targeted Print (TP, n = 216), and Usual Care (UC, n = 213). Theoretical mediators from the Extended Parallel Process Model, Health Action Planning Approach, and Ottawa Decision Support Framework were assessed at baseline and 1-month follow-up; CGRA uptake was assessed at 6 months. Generalized structural equation modeling was used for mediation analysis. Results The TCN effects were most strongly mediated by behavioral intention alone (β = 0.49 and 0.31) and by serial mediation through self-efficacy and intention (β = 0.041 and 0.10) when compared with UC and TP, respectively. In addition, compared with UC, the TCN also increased CGRA through increased perceived susceptibility, knowledge of HBOC, and response efficacy. Conclusions Risk communication and behavioral change interventions for hereditary cancer should stress a person’s increased genetic risk and the potential benefits of genetic counseling and testing, as well as bolster efficacy beliefs by helping remove barriers to CGRA. System-level and policy interventions are needed to further expand access.

Genetic Risk Assessment for Cancer Education and Empowerment (GRACE) Project

GRACE is a randomized 3-arm trial to determine the comparative effectiveness of two remote cancer communication interventions: 1) a targeted generic print (TP) or 2) a tailored telephone-based counseling and navigation intervention (TCN). Post-award, the target sample size was revised to (n=642) with NIH permission.