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

Soft Tissue Sarcoma Clinical Trial

— YonLife  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02204111
• Other study ID #: YonLife-2014
• Status: Completed
• Start date: September 2014
• Est. completion date: September 2017

Study information

• Verified date: November 2018
• Source: GWT-TUD GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcoma
• Soft Tissue Sarcoma

Intervention

Other:
• Intervention
Individualized treatment proposals (e.g. pain therapy, physiotherapy, psychological contact) from expert consensus, based on Patient Reported Outcomes

Locations

Country	Name	City	State
Germany	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 Muenster	Muenster
Germany	University Hospital Tuebingen	Tuebingen

Sponsors (2)

Lead Sponsor	Collaborator
GWT-TUD GmbH	PharmaMar

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Anxiety and depression (HADS)	assessed by the patient using standard questionnaire (HADS) via tablet-PC	baseline, 9, 21, 35 and 61 weeks
Secondary	Satisfaction with care (IN-PATSAT32)	assessed by the patient using standard questionnaire (IN-PATSAT32) via tablet-PC	baseline, 9, 21, 35 and 61 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	progression free survival		baseline up to 61 weeks
Secondary	Overall survival		baseline up to 61 weeks