A scalable new model of germline cancer genomic care delivery: Assessing psychological outcomes

PURPOSE: New care models promise to increase access to germline genetic testing. To decrease testing gaps, we offered universal germline testing without pretest genetic counseling to unselected patients at a comprehensive cancer center. To address safety concerns over the elimination of pretest counseling, we examined detrimental psychological impact (DPI) after participants underwent testing in this novel model. METHODS: We assessed participants' genomic testing-specific DPI using the Feelings About Genomic Testing Results instrument (2-weeks/6-months after disclosure). Overall DPI, negativity, uncertainty, positivity, and privacy concerns were assessed. We used chi-square, analysis of covariance multivariable regression, and mediation analysis to examine relationships between variables. RESULTS: A total of 846 participants completed the survey. Most participants (96.0%) exhibited low DPI, negativity (95.6%), uncertainty (94.0%), and concerns about privacy (95.6%) and high positivity (55.6%). Participants with cancer had higher negativity and uncertainty than those without. DPI significantly diminished over time in participants with positive tests. CONCLUSION: Overall DPI was low, demonstrating that most participants are at minimal psychological risk when receiving germline results without pre-test counseling. However, a small subset of participants exhibit high distress and uncertainty. Additional efforts are needed to identify at-risk participants receiving universal testing who would benefit from interventions aimed at mitigating DPI.