The value of a risk prediction tool (PERSARC) for effective treatment decisions of soft tissue sarcomas patients.

The value of a risk prediction tool (PERSARC) for effective treatment decisions of soft tissue sarcomas patients: a stepped wedge Randomized Controlled Trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24454

Enrollment

231

Registered

2021-01-08

Start date

2021-08-01

Completion date

Unknown

Last updated

2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

grade 2-3 soft tissue extremity sarcoma

Interventions

High-grade extremity STS patients 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

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Contacts

Public ContactAnouk Kruiswijk

LUMC

a.a.kruiswijk@lumc.nl0631974532

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)