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

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ClinicalTrials.gov Identifier: NCT02204111
Recruitment Status : Completed
First Posted : July 30, 2014
Last Update Posted : November 8, 2018
Sponsor:
Collaborator:
PharmaMar
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Soft Tissue Sarcoma Other: Intervention

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Study Type : Observational
Actual Enrollment : 77 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : September 2014
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Control Cluster
Care as usual
Treatment Cluster
Care as usual and patient directed, multidimensional treatment proposals
Other: Intervention
Individualized treatment proposals (e.g. pain therapy, physiotherapy, psychological contact) from expert consensus, based on Patient Reported Outcomes




Primary Outcome Measures :
  1. Health related QoL, measured by total score of FACT-G [ Time Frame: change to baseline at 9 weeks ]
    assessed by the patient using standard questionnaire (FACT-G) via tablet-PC


Secondary Outcome Measures :
  1. Dimensions of QoL (scales of FACT-G) [ Time Frame: baseline, 3, 6, 9, 21, 35 and 61 weeks ]
    assessed by the patient using standard questionnaire (FACT-G) via tablet-PC

  2. Anxiety and depression (HADS) [ Time Frame: baseline, 9, 21, 35 and 61 weeks ]
    assessed by the patient using standard questionnaire (HADS) via tablet-PC

  3. Satisfaction with care (IN-PATSAT32) [ Time Frame: baseline, 9, 21, 35 and 61 weeks ]
    assessed by the patient using standard questionnaire (IN-PATSAT32) via tablet-PC

  4. Anorexia and cachexia related impact on QoL (FAACT) [ Time Frame: baseline, 9, 21, 35 and 61 weeks ]
    assessed by the patient using standard questionnaire (FAACT) via tablet-PC

  5. Intensity of pain and pain related interference (BPI) [ Time Frame: baseline, 9, 21, 35 and 61 weeks ]
    assessed by the patient using standard questionnaire (BPI) via tablet-PC

  6. Severity of cancer-related symptoms (MDASI) [ Time Frame: baseline, 3, 6, 9, 21, 35 and 61 weeks ]
    assessed by the patient using standard questionnaire (MDASI) via tablet-PC

  7. progression free survival [ Time Frame: baseline up to 61 weeks ]
  8. Overall survival [ Time Frame: baseline up to 61 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Soft Tissue Sarcoma under palliative treatment with Trabectedin
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02204111


Locations
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Germany
University Hospital Carl Gustav Carus, MK I
Dresden, Saxony, Germany, 01307
Charité
Berlin, Germany, 13353
Hannover Medical School
Hannover, Germany, 30625
University Hospital Koeln
Koeln, Germany, 50937
University Medical Centre Mannheim
Mannheim, Germany, 68167
University Hospital Muenster
Muenster, Germany, 48149
University Hospital Tuebingen
Tuebingen, Germany, 72076
Sponsors and Collaborators
GWT-TUD GmbH
PharmaMar
Investigators
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Principal Investigator: Markus Schuler, Dr. med. University Hospital Carl Gustav Carus, Dresden
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT02204111    
Other Study ID Numbers: YonLife-2014
First Posted: July 30, 2014    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Keywords provided by GWT-TUD GmbH:
Palliative Treatment
Trabectedin
Patient Reported Outcome
Additional relevant MeSH terms:
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Sarcoma
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms