Clinical trial · Interventional
The Value of a Risk Prediction Tool (PERSARC) for Effective Treatment Decisions of Soft-tissue Sarcomas Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to assess the (cost-)effectiveness of a personalised risk assessment tool (PERSARC) to increase patients' knowledge about risks and benefits of treatment options and to reduce decisional conflict in comparison with usual care in high-grade extremity Soft-Tissue Sarcoma-patients. High-grade (2-3) extremity Soft-Tissue Sarcoma patients (\>= 18 years) will either receive standard care (control group) or care with the use of PERSARC; i.e. PERSARC will be used in multidisciplinary tumour boards to guide treatment advice and in consultation in which the oncological/orthopaedic surgeon informs the patient about his/her diagnoses and discusses the benefits and harms of all relevant treatment options (intervention group)
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Predictive Cancer Model | Sarcoma | PROBABILISTIC | 0.70 |
| Soft-tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Care with the use of PERSARC | Other | — | UNRESOLVED |
| standard care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Care with the use of PERSARC (intervention)
- description
- Patients in the intervention condition receive usual care with PERSARC added at two points in the decision making process. First, PERSARC will be used in multidisciplinary tumour boards (MTB) by STS professionals to guide treatment advice. Second, PERSARC will be used in patient consultations where the oncological/orthopaedic surgeon informs the patient about his/her diagnosis and discusses the benefits and harms of all relevant treatment options.
- interventionNames
- Other: Care with the use of PERSARC
- type
- SHAM_COMPARATOR
- label
- standard care (control)
- description
- All patients in the control condition receive standard care
- interventionNames
- Other: standard care
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients \>= 18 years * Histologically diagnosed with grade 2-3 STS in their extremities. * Who do not have a treatment plan yet * Dutch fluency and literacy * Mentally competent * Signed informed consent * Patient owns a phone with internet access (WiFi) Exclusion Criteria: * Patient that are treated without curative intent * Patient that needs to be treated with chemotherapy or isolated limb perfusion * Patients were surgery is not indicated * Sarcoma subtypes not included in the PERSARC risk assessment tool In summary: patients with sarcoma subtypes and/or patients that need to be treated with other treatment modalities than those included in the PERSARC risk assessment tool are excluded.
References
Publications (2)
- DERIVEDKruiswijk AA, de Mheen PJM, Vlug LAE, Engelhardt EG, Fiocco M, Haas RL, Schrage YM, Verhoef C, Bemelmans MHA, van Ginkel RJ, Bonenkamp JJ, Witkamp AJ, van de Sande MAJ, van Bodegom-Vos L; VALUE-PERSARC research group. Evaluating the effectiveness of a risk prediction model (PERSARC) on improving treatment decisions quality for patients with soft-tissue sarcomas: the VALUE-PERSARC study. BMC Med Inform Decis Mak. 2025 Sep 29;25(1):345. doi: 10.1186/s12911-025-03166-6. PMID 41023919
- DERIVEDKruiswijk AA, van de Sande MAJ, Haas RL, van den Akker-van Marle EM, Engelhardt EG, Marang-van de Mheen P, van Bodegom-Vos L; VALUE-PERSARC research group. (Cost-)effectiveness of an individualised risk prediction tool (PERSARC) on patient's knowledge and decisional conflict among soft-tissue sarcomas patients: protocol for a parallel cluster randomised trial (the VALUE-PERSARC study). BMJ Open. 2023 Nov 2;13(11):e074853. doi: 10.1136/bmjopen-2023-074853. PMID 37918933