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Completed

NCT Number: NCT02204111

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

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.

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Key information

Conditions

Soft Tissue Sarcoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Sarcoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Carl Gustav Carus, MK I, Dresden, Saxony, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

GWT-TUD GmbH

Other

Collaborators

  • PharmaMar

Registry information

Official study 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

Acronym: YonLife

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 30, 2014
Registry last updated
Nov 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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