Clinical trial · Observational
Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma
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
NCT02204111CI-TRIAL-00035703YonLifecompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Soft Tissue Sarcoma | Soft Tissue Sarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Control Cluster
- description
- Care as usual
- label
- Treatment Cluster
- description
- Care as usual and patient directed, multidimensional treatment proposals
- interventionNames
- Other: Intervention
Primary outcomes (1)
- measure
- Health related QoL, measured by total score of FACT-G
- timeFrame
- change to baseline at 9 weeks
- description
- assessed by the patient using standard questionnaire (FACT-G) via tablet-PC
Secondary outcomes (8)
- measure
- Dimensions of QoL (scales of FACT-G)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDHentschel L, Richter S, Kopp HG, Kasper B, Kunitz A, Grunwald V, Kessler T, Chemnitz JM, Pelzer U, Schuler U, Freitag J, Schilling A, Hornemann B, Arndt K, Bornhauser M, Schuler MK. Quality of life and added value of a tailored palliative care intervention in patients with soft tissue sarcoma undergoing treatment with trabectedin: a multicentre, cluster-randomised trial within the German Interdisciplinary Sarcoma Group (GISG). BMJ Open. 2020 Aug 27;10(8):e035546. doi: 10.1136/bmjopen-2019-035546. PMID 32859662
- DERIVEDSchuler M, Richter S, Ehninger G, Bornhauser M, Hentschel L. A cluster-randomised, controlled proof-of-concept study to explore the feasibility and effect of a patient-directed intervention on quality of life in patients with advanced soft tissue sarcoma. BMJ Open. 2017 Jun 30;7(6):e014614. doi: 10.1136/bmjopen-2016-014614. PMID 28667207