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Soft Tissue SarcomaYonLifeNCT02204111

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

An observational study of Soft Tissue Sarcoma, run by GWT-TUD GmbH at 7 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Soft Tissue Sarcoma
What is being tested?
Intervention
How many people
77 participants
Where
7 sitesGermany
Study dates
Sep 2014to Sep 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with Soft Tissue Sarcoma under palliative treatment with Trabectedin

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

Germany7 sites

  • Charité

    Berlin, 13353

  • University Hospital Koeln

    Cologne, 50937

  • University Hospital Carl Gustav Carus, MK I

    Dresden, Saxony, 01307

  • Hannover Medical School

    Hanover, 30625

  • University Medical Centre Mannheim

    Mannheim, 68167

  • University Hospital Muenster

    Münster, 48149

  • University Hospital Tuebingen

    Tübingen, 72076

Other trials in Germany

About this study

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

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.

Being tested
Intervention
Keywords
Palliative Treatment, Trabectedin, Patient Reported Outcome
Medical subject headings
Sarcoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • InterventionOther

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

Study groups in NCT02204111
Study groupRoleWhat they receive
Control ClusterCare as usual
Treatment ClusterCare as usual and patient directed, multidimensional treatment proposals
Receives: Other: Intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: change to baseline at 9 weeks

Secondary outcomes (8)

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

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: baseline, 3, 6, 9, 21, 35 and 61 weeks

  7. progression free survival

    Measured: baseline up to 61 weeks

  8. Overall survival

    Measured: baseline up to 61 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2014 (estimated)
  2. Study startSep 2014
  3. Primary completionSep 2017
  4. Study completionSep 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02204111
Sponsor's protocol ID
YonLife-2014
Acronym
YonLife
Status last verified
Nov 2018
First submitted
9 Jul 2014
Last updated
8 Nov 2018
Results posted
No
Data monitoring committee
No

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

Questions about this trial

What is this clinical trial studying?

An observational study of Soft Tissue Sarcoma, run by GWT-TUD GmbH at 7 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health related QoL, measured by total score of FACT-G (time frame: change to baseline at 9 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02204111, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2018.

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