CClinicalTrials.gg
Sign In
CompletedNCT02204111YonLifeUpdated Nov 8, 2018

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

An observational study in Soft Tissue Sarcoma, sponsored by GWT-TUD GmbH. Completed at 7 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-11-08.

Sponsored by GWT-TUD GmbH · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
77
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Soft Tissue Sarcoma

Browse trials for

Keywords

  • Palliative Treatment
  • Trabectedin
  • Patient Reported Outcome
03

In context

Sarcoma

1,667 studies on the registry are indexed under Sarcoma; 393 are open to participants now.

This study's enrollment of 77 is below the median of 121 across 238 observational studies indexed under Sarcoma.

Browse Sarcoma studies →

Lead sponsor

GWT-TUD GmbH is the lead sponsor of 39 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with Soft Tissue Sarcoma under palliative treatment with Trabectedin

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

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
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
77 participants (actual)
Patient registry
No

Groups and cohorts

  • Control Cluster

    Care as usual

  • Treatment Cluster

    Care as usual and patient directed, multidimensional treatment proposals

    Other: Intervention

Interventions

  • OtherIntervention

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

06

What researchers measure

Primary outcomes

  1. Health related QoL, measured by total score of FACT-G

    assessed by the patient using standard questionnaire (FACT-G) via tablet-PC

    Time frame: change to baseline at 9 weeks

Secondary outcomes

  1. Dimensions of QoL (scales of FACT-G)

    assessed by the patient using standard questionnaire (FACT-G) via tablet-PC

    Time frame: baseline, 3, 6, 9, 21, 35 and 61 weeks

  2. Anxiety and depression (HADS)

    assessed by the patient using standard questionnaire (HADS) via tablet-PC

    Time frame: baseline, 9, 21, 35 and 61 weeks

  3. Satisfaction with care (IN-PATSAT32)

    assessed by the patient using standard questionnaire (IN-PATSAT32) via tablet-PC

    Time frame: baseline, 9, 21, 35 and 61 weeks

  4. Anorexia and cachexia related impact on QoL (FAACT)

    assessed by the patient using standard questionnaire (FAACT) via tablet-PC

    Time frame: baseline, 9, 21, 35 and 61 weeks

  5. Intensity of pain and pain related interference (BPI)

    assessed by the patient using standard questionnaire (BPI) via tablet-PC

    Time frame: baseline, 9, 21, 35 and 61 weeks

  6. Severity of cancer-related symptoms (MDASI)

    assessed by the patient using standard questionnaire (MDASI) via tablet-PC

    Time frame: baseline, 3, 6, 9, 21, 35 and 61 weeks

  7. progression free survival

    Time frame: baseline up to 61 weeks

  8. Overall survival

    Time frame: baseline up to 61 weeks

07

Study locations

7 sites
  • University Hospital Carl Gustav Carus, MK I
    Dresden, Saxony 01307, Germany
  • Charité
    Berlin, 13353, Germany
  • Hannover Medical School
    Hannover, 30625, Germany
  • University Hospital Koeln
    Koeln, 50937, Germany
  • University Medical Centre Mannheim
    Mannheim, 68167, Germany
  • University Hospital Muenster
    Muenster, 48149, Germany
  • University Hospital Tuebingen
    Tuebingen, 72076, Germany
08

References and documents

Publications

  • Hentschel L, Richter S, Kopp HG, Kasper B, Kunitz A, Grunwald V, Kessler T, Chemnitz JM, Pelzer U, Schuler U, Freitag J, Schilling A, Hornemann B, Arndt K, Bornhauser M, Schuler MK. Quality of life and added value of a tailored palliative care intervention in patients with soft tissue sarcoma undergoing treatment with trabectedin: a multicentre, cluster-randomised trial within the German Interdisciplinary Sarcoma Group (GISG). BMJ Open. 2020 Aug 27;10(8):e035546. doi: 10.1136/bmjopen-2019-035546. PubMed 32859662 ↗
  • Schuler M, Richter S, Ehninger G, Bornhauser M, Hentschel L. A cluster-randomised, controlled proof-of-concept study to explore the feasibility and effect of a patient-directed intervention on quality of life in patients with advanced soft tissue sarcoma. BMJ Open. 2017 Jun 30;7(6):e014614. doi: 10.1136/bmjopen-2016-014614. PubMed 28667207 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02204111
Lead sponsor
GWT-TUD GmbH
Collaborators
PharmaMar
Responsible party
Sponsor
First posted
Jul 30, 2014
Start date
Sep 2014
Primary completion
Sep 2017
Completion
Sep 2017
Last update
Nov 8, 2018

Study contacts

Markus Schuler, Dr. med.
principal investigator · University Hospital Carl Gustav Carus, Dresden

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Sarcoma→

Other studies from this sponsor

GWT-TUD GmbH

Start the discussion