Care with the use of PERSARC: PERSARC is a personalized risk assessment tool which provides patients and STS professionals insight into the personalized risks and benefits of each treatment option based on patient's age, tumor size, tumor depth and histology. 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
standard care: All patients in control condition receive usual care.
Study 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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Decisional Conflict Scale — T1 (one week after treatment decision) Decisional conflict scale
Items are given a score value of:
strongly agree (0) - strongly disagree (4)
Total score:
16 items are a) summed, b) divided by 16, and c) multiplied by 25. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict)
Informed choice — T1 (one week after treatment decision) combined outcome incorporating knowledge (self-developed questionnaire), attitudes concerning trade-offs between quality and length of life (QQ\_Questionnaire, see below) and treatment decision
self-developed knowledge questionnaire: a knowledge score was considered to reflect adequate decision-relevant knowledge if at least 50% of knowledge statements were correctly answered, which means a knowledge score ≥3 for the present study; no knowledge (0) - high knowledge (6)
Trial sites (7)
Facility
City
Region
Status
Radboud UMC
Nijmegen
Gelderland
Maastricht UMC
Maastricht
Limburg
Netherlands Cancer Institue
Amsterdam
North Holland
UMC Groningen
Groningen
Provincie Groningen
Leiden University Medical Center
Leiden
South Holland
Erasmus MC
Rotterdam
South Holland
UMC Utrecht
Utrecht
Utrecht
More Leiden University Medical Center trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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