Soft Tissue Sarcoma
Conditions
Keywords
Palliative Treatment, Trabectedin, Patient Reported Outcome
Brief summary
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.
Interventions
OTHERIntervention
Individualized treatment proposals (e.g. pain therapy, physiotherapy, psychological contact) from expert consensus, based on Patient Reported Outcomes
Sponsors
PharmaMar
GWT-TUD GmbH
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health related QoL, measured by total score of FACT-G | change to baseline at 9 weeks | assessed by the patient using standard questionnaire (FACT-G) via tablet-PC |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety and depression (HADS) | baseline, 9, 21, 35 and 61 weeks | assessed by the patient using standard questionnaire (HADS) via tablet-PC |
| Satisfaction with care (IN-PATSAT32) | baseline, 9, 21, 35 and 61 weeks | assessed by the patient using standard questionnaire (IN-PATSAT32) via tablet-PC |
| Anorexia and cachexia related impact on QoL (FAACT) | baseline, 9, 21, 35 and 61 weeks | assessed by the patient using standard questionnaire (FAACT) via tablet-PC |
| Dimensions of QoL (scales of FACT-G) | baseline, 3, 6, 9, 21, 35 and 61 weeks | assessed by the patient using standard questionnaire (FACT-G) via tablet-PC |
| Severity of cancer-related symptoms (MDASI) | baseline, 3, 6, 9, 21, 35 and 61 weeks | assessed by the patient using standard questionnaire (MDASI) via tablet-PC |
| progression free survival | baseline up to 61 weeks | — |
| Overall survival | baseline up to 61 weeks | — |
| Intensity of pain and pain related interference (BPI) | baseline, 9, 21, 35 and 61 weeks | assessed by the patient using standard questionnaire (BPI) via tablet-PC |
Countries
Germany
Outcome results
None listed