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

GWT-TUD

Status

Completed

Conditions

Soft Tissue Sarcoma

Treatments

Other: Intervention

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02204111

YonLife-2014

Details and patient eligibility

About

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.

Enrollment

77 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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