Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma
NCT ID: NCT02204111
Last Updated: 2018-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
77 participants
OBSERVATIONAL
2014-09-30
2017-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Geriatric Assessmen of Elderly "Unsuited" Patients Receiving Trabectedin in First Line Treatment For Advanced Soft Tissue Sarcomas (STS)
NCT03022448
Trabectedin Plus Radiotherapy in Soft Tissue Sarcoma Patients
NCT02275286
Stereotactic Radiosurgery for Soft Tissue Sarcoma
NCT02706171
Short Course of Radiotherapy Prior to Surgery of Soft Tissue Sarcomas
NCT07071727
Preoperative Radiotherapy for Sarcomas of the Extremities With Intensity-Modulation, Image-Guidance and Small Safety-margins
NCT01552239
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control Cluster
Care as usual
No interventions assigned to this group
Treatment Cluster
Care as usual and patient directed, multidimensional treatment proposals
Intervention
Individualized treatment proposals (e.g. pain therapy, physiotherapy, psychological contact) from expert consensus, based on Patient Reported Outcomes
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Intervention
Individualized treatment proposals (e.g. pain therapy, physiotherapy, psychological contact) from expert consensus, based on Patient Reported Outcomes
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
PharmaMar
INDUSTRY
GWT-TUD GmbH
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Markus Schuler, Dr. med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Carl Gustav Carus, Dresden
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Carl Gustav Carus, MK I
Dresden, Saxony, Germany
Charité
Berlin, , Germany
University Hospital Koeln
Cologne, , Germany
Hannover Medical School
Hanover, , Germany
University Medical Centre Mannheim
Mannheim, , Germany
University Hospital Muenster
Münster, , Germany
University Hospital Tuebingen
Tübingen, , Germany
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
YonLife-2014
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.