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NCT05741944
The Value of a Risk Prediction Tool (PERSARC) for Effective Treatment Decisions of Soft-tissue Sarcomas Patients
Conditions: Soft-tissue Sarcoma, Predictive Cancer Model
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 120
Sponsor: Leiden University Medical Center
Location: Netherlands
Summary
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)
Eligibility Criteria
Inclusion Criteria:Patients >= 18 yearsHistologically diagnosed with grade 2-3 STS in their extremities.Who do not have a treatment plan yetDutch fluency and literacyMentally competentSigned informed consentPatient owns a phone with internet access (WiFi)Exclusion Criteria:Patient that are treated without curative intentPatient that needs to be treated with chemotherapy or isolated limb perfusionPatients were surgery is not indicatedSarcoma subtypes not included in the PERSARC risk assessment toolIn 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.
Source: ClinicalTrials.gov (NCT05741944). StuddyBuddy aggregates publicly available trial information.