Using a risk prediction tool to help treat patients with soft-tissue sarcomas
The Value of a Risk Prediction Tool (PERSARC) for Effective Treatment Decisions of Soft-tissue Sarcomas Patients
NA · Leiden University Medical Center · NCT05741944
This study is testing a new tool to help doctors make better treatment choices for patients with high-grade soft-tissue sarcomas and see if it improves their understanding and satisfaction with their care.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Leiden University Medical Center (other) |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Nijmegen, Gelderland and 6 other locations) |
| Trial ID | NCT05741944 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of a personalized risk assessment tool called PERSARC in aiding treatment decisions for patients with high-grade extremity soft-tissue sarcomas. Participants will be divided into two groups: one receiving standard care and the other receiving care informed by PERSARC during consultations with their oncological or orthopedic surgeons. The study aims to reduce decisional conflict and enhance patient knowledge regarding treatment options. Outcomes will be assessed at multiple time points after the treatment decision is made to evaluate the tool's impact on patient involvement and satisfaction.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a histologically diagnosed grade 2-3 soft-tissue sarcoma in their extremities who have not yet established a treatment plan.
Not a fit: Patients requiring treatments not included in the PERSARC tool, such as those needing chemotherapy or isolated limb perfusion, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could empower patients with better knowledge and confidence in their treatment decisions, potentially leading to improved outcomes.
How similar studies have performed: While the use of personalized risk assessment tools in oncology is gaining traction, this specific approach with PERSARC is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Nijmegen, Gelderland and 6 other locations
- Radboud UMC — Nijmegen, Gelderland, Netherlands (RECRUITING)
- Maastricht UMC — Maastricht, Limburg, Netherlands (RECRUITING)
- Netherlands Cancer Institue — Amsterdam, Noord-Holland, Netherlands (RECRUITING)
- Leiden University Medical Center — Leiden, Zuid-holland, Netherlands (RECRUITING)
- Erasmus MC — Rotterdam, Zuid-Holland, Netherlands (RECRUITING)
- UMC Groningen — Groningen, Netherlands (RECRUITING)
- UMC Utrecht — Utrecht, Netherlands (RECRUITING)
Study contacts
- Principal investigator: Leti van Bodegom-Vos, PhD — LUMC
- Study coordinator: Anouk A Kruiswijk, MSc
- Email: a.a.kruiswijk@lumc.nl
- Phone: +31715265137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Soft-tissue Sarcoma, Predictive Cancer Model