The value of a risk prediction tool (PERSARC) for effective treatment decisions of soft tissue sarcomas patients.
- Conditions
- grade 2-3 soft tissue extremity sarcoma
- Registration Number
- NL-OMON24454
- Lead Sponsor
- KWF kankerbestrijding
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 231
Inclusion Criteria
Patients (>= 18 years) with primarily diagnosed (histologically confirmed) grade 2-3 extremity STS, who do not have a treatment plan yet and will be treated with curative intent. Patients with sarcoma subtypes or treatment options other than those mentioned in the PERSARC app are unable to participate. Furthermore, patients need to be Dutch fluency and literacy and mentally competent.
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 mentioned in the PERSARC app
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The co-primary outcomes are decisional conflict (Decisional Conflict Scale(DCS)) and informed choice. Informed choice is a combined outcome incorporating knowledge, attitudes concerning trade-offs between quality and length of life (QQ_Questionnaire), and treatment decision.
- Secondary Outcome Measures
Name Time Method Secondary outcomes, include regret (Decision_Regret_Scale) (T3, T4), worry (Cancer_Worry_scale) (T1, T2, T3, T4), involvement in decision-making according to patients (SDM-Q-9) (T1), patient reported outcome using the Patient Reported Outcome Measures (PROMIS Global health) (T1, 2, 3, 4), and (PROMIS physical function) (T1, 2, 3, 4), utilities for the cost-effectiveness analysis (EQ-5D-5L) (T1, T2, T3, T4), health care cost (iMCQ) (T2, T3, T4) and absenteeism/presenteeism from paid work (T2, T3, T4).