Evaluating the effectiveness of a risk prediction model (PERSARC) on improving treatment decisions quality for patients with soft-tissue sarcomas: the VALUE-PERSARC study.

BACKGROUND

Risk prediction models (RPM) can potentially improve treatment decisions by providing personalized survival estimates for different treatment options, but their effectiveness is uncertain. The VALUE-PERSARC study evaluated the impact of the PERsonalised SARcoma Care (or PERSARC) RPM on decision-making quality in patients with high-grade extremity soft tissue sarcomas (STS).

METHODS

A parallel cluster randomized controlled trial was conducted in seven Dutch hospitals, assigned to usual care (control) or care with PERSARC (intervention). PERSARC supported treatment recommendations and informed patients about personalized risks and relevant treatment options. The primary outcome was decision-making quality, measured by patients’ knowledge of treatment risks and benefits and decisional conflict (Decisional Conflict Scale). Secondary outcomes included the Cancer Worry Scale (CWS), Shared Decision-Making (SDM-Q9), number of treatment options discussed and treatment choice.

RESULTS

This study enrolled 120 patients: 53 patients in the control group and 67 patients in the intervention group. No significant differences were observed between the control and intervention groups in patients’ adequate knowledge (respectively 82% vs. 86%) and decisional conflict (respectively 23.1 [15.5] vs. 18.9 [12.8]). Scores on the CWS (11.7 [3.3] vs. 11.0 [3.5]) and SDM-Q9 (13.3 [4.0] vs. 15.6 [3.3]) were also similar. Treatment choices did not differ significantly between groups. However, clinicians in the intervention group were significantly more likely to discuss multiple treatment options (93% vs. 35%).

CONCLUSION

While PERSARC did not significantly improve patients’ knowledge or decisional conflict, it led to more frequent discussion of multiple treatment options by clinicians. This may be an important step towards enhancing shared decision-making in practice. Trail registration: The VALUE-PERSARC study was registered on January 8, 2021 in the Netherlands Trial Register (NL9160) and updated on January 23, 2023 in ClinicalTrials.gov (NCT05741944). TRIAL REGISTRATION: The VALUE-PERSARC study was initially registered in the Netherlands Trial Register (NL9160) on January 8, 2021, and subsequently updated in ClincicalTrials.gov (NCT05741944) on January 31, 2023.