Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma

Study Overview
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Brief Summary
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The primary objective of the study is to compare quality of life (QoL) between patients suffering from soft tissue sarcoma, receiving a multidimensional intervention with those receiving standard treatment.

Official Title
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Patient Directed Intervention Towards a Multidimensional Recommendation Guideline to Improve the Quality of Life for Patients With Soft Tissue Sarcoma Under Palliative Treatment With Trabectedin

Conditions
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Soft Tissue Sarcoma

Intervention / Treatment
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* Other: Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of advanced or metastatic soft tissue sarcoma Treatment with trabectedin in an in-label prescription Age at least 18 years (inclusive) at the first visit Patients with a life expectancy of at least 6 months The informed consent form must be signed before any study specific tests or procedures are done Confirmation of the subject's health insurance coverage prior to the first visit Ability to understand and follow study-related instructions Exclusion Criteria: ECOG PS >2 Estimated life expectancy of less than 6 months Patients with STS not receiving trabectedin Contraindications according to the local SmPC of Yondelis® Subject is in custody by order of an authority or a court of law Exclusion periods from other studies or simultaneous participation in other clinical studies Previous assignment to treatment during this study Close affiliation with the investigator (e.g. a close relative) or persons working at the study site Subject is an employee of GWT-TUD GmbH or Pharma Mar S.A. Criteria which in the opinion of the investigator preclude participation for scientific reasons, for reasons of compliance, or for reasons of the subject's safety

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Cluster<br>Care as usual | |
| Treatment Cluster<br>Care as usual and patient directed, multidimensional treatment proposals | Other: Intervention<br>* Individualized treatment proposals (e.g. pain therapy, physiotherapy, psychological contact) from expert consensus, based on Patient Reported Outcomes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related QoL, measured by total score of FACT-G | assessed by the patient using standard questionnaire (FACT-G) via tablet-PC | change to baseline at 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dimensions of QoL (scales of FACT-G) | assessed by the patient using standard questionnaire (FACT-G) via tablet-PC | baseline, 3, 6, 9, 21, 35 and 61 weeks | 
| Anxiety and depression (HADS) | assessed by the patient using standard questionnaire (HADS) via tablet-PC | baseline, 9, 21, 35 and 61 weeks | 
| Satisfaction with care (IN-PATSAT32) | assessed by the patient using standard questionnaire (IN-PATSAT32) via tablet-PC | baseline, 9, 21, 35 and 61 weeks | 
| Anorexia and cachexia related impact on QoL (FAACT) | assessed by the patient using standard questionnaire (FAACT) via tablet-PC | baseline, 9, 21, 35 and 61 weeks | 
| Intensity of pain and pain related interference (BPI) | assessed by the patient using standard questionnaire (BPI) via tablet-PC | baseline, 9, 21, 35 and 61 weeks | 
| Severity of cancer-related symptoms (MDASI) | assessed by the patient using standard questionnaire (MDASI) via tablet-PC | baseline, 3, 6, 9, 21, 35 and 61 weeks | 
| progression free survival |  | baseline up to 61 weeks | 
| Overall survival |  | baseline up to 61 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Palliative Treatment, Trabectedin, Patient Reported Outcome