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.
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
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.
- Conditions
- Soft Tissue Sarcoma
- 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 group | Role | What they receive |
|---|---|---|
| Control Cluster | Care as usual | |
| Treatment Cluster | Care 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.
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)
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
Anxiety and depression (HADS)
assessed by the patient using standard questionnaire (HADS) via tablet-PC
Measured: baseline, 9, 21, 35 and 61 weeks
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
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
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
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
progression free survival
Measured: baseline up to 61 weeks
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.
- First posted30 Jul 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Soft Tissue SarcomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- GWT-TUD GmbH
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaMar
- Responsible party
- Sponsor
- Investigators
- Markus Schuler, Dr. med., Principal investigator, University Hospital Carl Gustav Carus, Dresden
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 32859662Schuler 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
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02204111
- Acronym / sponsor ID
- YonLife / YonLife-2014
- Conditions
- Soft Tissue Sarcoma
- Keywords
- Palliative Treatment, Trabectedin, Patient Reported Outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- GWT-TUD GmbHUniversity, hospital or other
- Collaborators
- PharmaMar
- Study start
- Sep 2014 (actual)
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 30 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Cluster | – | –Care as usual |
| Treatment Cluster | – | Other: InterventionCare as usual and patient directed, multidimensional treatment proposals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Soft Tissue Sarcoma under palliative treatment with Trabectedin
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionIndividualized treatment proposals (e.g. pain therapy, physiotherapy, psychological contact) from expert consensus, based on Patient Reported Outcomes | Other | Treatment Cluster |
Primary outcome
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
8 secondary outcomes
Dimensions of QoL (scales of FACT-G)
Time frame: baseline, 3, 6, 9, 21, 35 and 61 weeks
Anxiety and depression (HADS)
Time frame: baseline, 9, 21, 35 and 61 weeks
Satisfaction with care (IN-PATSAT32)
Time frame: baseline, 9, 21, 35 and 61 weeks
Anorexia and cachexia related impact on QoL (FAACT)
Time frame: baseline, 9, 21, 35 and 61 weeks
Intensity of pain and pain related interference (BPI)
Time frame: baseline, 9, 21, 35 and 61 weeks
Severity of cancer-related symptoms (MDASI)
Time frame: baseline, 3, 6, 9, 21, 35 and 61 weeks
progression free survival
Time frame: baseline up to 61 weeks
Overall survival
Time frame: baseline up to 61 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- Derived from this study: PubMed 32859662Hentschel 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.
- Derived from this study: PubMed 28667207Schuler 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Markus Schuler, Dr. med. principal investigator
University Hospital Carl Gustav Carus, Dresden
7 sites in 1 country: see every site and its status.
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.