The value of a risk prediction tool (PERSARC) for effectvie treatment decision making: a stepped wedge Randomized Controlled Trial.
Recruiting
- Conditions
- soft tissue extremity sarcomas10041297
- Registration Number
- NL-OMON51872
- Lead Sponsor
- eids Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 120
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 smartphone 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 mentioned in the PERSARC app
In summary: patients with sarcoma subtypes and/or patients that need to be
treated with other treatment modalities than those mentioned in the PERSARC app
are excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The co-primary outcomes are decisional conflict (Decisional Conflict Scale(DCS)<br /><br>(T1,) and informed choice (T1). Informed choice is a combined outcome<br /><br>incorporating knowledge, attitudes concerning trade-offs between quality and<br /><br>length of life (QQ_Questionnaire) (T1), and treatment decision (T1). </p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes, include regret (Decision_Regret_Scale) (T3, T4), worry<br /><br>(Cancer_Worry_scale) (T1, T2, T3, T4), involvement in decision-making according<br /><br>to patients (SDM-Q-9) (T1), patient reported outcome using the Patient Reported<br /><br>Outcome Measures (PROMIS Global health) (T1, 2, 3, 4), and (PROMIS physical<br /><br>function) (T1, 2, 3, 4), utilities for the cost-effectiveness analysis<br /><br>(EQ-5D-5L) (T1, T2, T3, T4), health care cost (iMCQ) (T2, T3, T4) and<br /><br>absenteeism/presenteeism from paid work (T2, T3, T4).</p><br>