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

Completed

• Conditions: Soft Tissue Sarcoma
• Interventions: Other: Intervention

• Registration Number: NCT02204111
• Lead Sponsor: GWT-TUD GmbH

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-09
• Study First Submitted QC: 2014-07-28
• Study First Posted: 2014-07-30
• Study Start: 2014-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-07
• Last Update Posted: 2018-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Cluster	Intervention	Care as usual and patient directed, multidimensional treatment proposals

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Anxiety and depression (HADS)	baseline, 9, 21, 35 and 61 weeks	assessed by the patient using standard questionnaire (HADS) 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
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
progression free survival	baseline up to 61 weeks
Overall survival	baseline up to 61 weeks
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
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

Trial Locations

Locations (7)

Charité; 🇩🇪 Berlin, Germany

University Hospital Carl Gustav Carus, MK I; 🇩🇪 Dresden, Saxony, Germany

Hannover Medical School; 🇩🇪 Hannover, Germany

University Hospital Koeln; 🇩🇪 Koeln, Germany

University Medical Centre Mannheim; 🇩🇪 Mannheim, Germany

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany

University Hospital Muenster; 🇩🇪 Muenster, Germany