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).

Introduction: Changes in health-related quality of life (HRQoL) during the diagnostic and treatment trajectory of high-grade extremity soft-tissue sarcoma (eSTS) has rarely been investigated for adults (18–65 y) and the elderly (aged ≥65 y), despite a potential variation in challenges from diverse levels of physical, social, or work-related activities. This study assesses HRQoL from time of diagnosis to one year thereafter among adults and the elderly with eSTS. Methods: HRQoL of participants from the VALUE-PERSARC trial (n = 97) was assessed at diagnosis and 3, 6 and 12 months thereafter, utilizing the PROMIS Global Health (GH), PROMIS Physical Function (PF) and EQ-5D-5L. Results: Over time, similar patterns were observed in all HRQoL measures, i.e., lower HRQoL scores than the Dutch population at baseline (PROMIS-PF:46.8, PROMIS GH-Mental:47.3, GH-Physical:46.2, EQ-5D-5L:0.76, EQ-VAS:72.6), a decrease at 3 months, followed by an upward trend to reach similar scores as the general population at 12 months (PROMIS-PF:49.9, PROMIS GH-Physical:50.1, EQ-5D-5L:0.84, EQ-VAS:81.5), except for the PROMIS GH-Mental (47.5), where scores remained lower than the general population mean (T = 50). Except for the PROMIS-PF, no age-related differences were observed. Conclusions: On average, eSTS patients recover well physically from surgery, yet the mental component demonstrates no progression, irrespective of age. These results underscore the importance of comprehensive care addressing both physical and mental health.

Background. The majority of the benign and malignant lesions in the breast arise from the ductal epithelium and terminal ductlobular unit. A minimally invasive procedure called ductoscopy is able to visualize these lesions as it inspects the ductal epithelium using a small micro-endoscope. Unfortunately, it is currently challenging to obtain a tissue sample during ductoscopy and reach the most distal duct. Methods. In this study we have, therefore, developed a novel miniature (∅1.2 mm) biopsy needle that can be used during ductoscopy. This biopsy needle consists of two coaxial counter-rotating hollow blades with a distal cutout to resect lesions from the ductal wall. Three cutouts were manufactured resulting in a beveled, straight, and reverse-beveled blade. The blades were actuated using a novel mechanism containing two helical paths that allows for the counter-rotating motion of the blades at different velocities. In a proof-of-principle experiment, the performance of the biopsy needle was evaluated using a polymeric duct model and gelatin tissue phantom. Results. During the experiment, the straight and reverse-beveled blades were able to obtain a sufficiently large tissue sample for histopathological examination. Based on these promising results, a second experiment was performed in which the micro-endoscope was integrated in the needle and we were able to take a biopsy from a chicken breast. Conclusions. In a future clinical instrument, the biopsy needle will be miniaturized and optimized to allow for an efficient, safe, and effective intraductal biopsy procedure without the need for an invasive excisional biopsy procedure.