Clinical trial NCT02204111: Patient Directed Intervention to Improve the Quality of Life for Patients With Soft Tissue Sarcoma
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Soft Tissue Sarcoma
Keywords: Palliative Treatment
Trabectedin
Patient Reported Outcome
Lead sponsor: GWT-TUD GmbH
Sponsor class: OTHER
Collaborators: name: PharmaMar
First posted: 2014-07-30
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with Soft Tissue Sarcoma under palliative treatment with Trabectedin

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Health related QoL, measured by total score of FACT-G
timeFrame: change to baseline at 9 weeks
Secondary outcomes:
measure: Dimensions of QoL (scales of FACT-G)
timeFrame: baseline, 3, 6, 9, 21, 35 and 61 weeks
measure: Anxiety and depression (HADS)
timeFrame: baseline, 9, 21, 35 and 61 weeks
measure: Satisfaction with care (IN-PATSAT32)
timeFrame: baseline, 9, 21, 35 and 61 weeks
measure: Anorexia and cachexia related impact on QoL (FAACT)
timeFrame: baseline, 9, 21, 35 and 61 weeks
measure: Intensity of pain and pain related interference (BPI)
timeFrame: baseline, 9, 21, 35 and 61 weeks
measure: Severity of cancer-related symptoms (MDASI)
timeFrame: baseline, 3, 6, 9, 21, 35 and 61 weeks
measure: progression free survival
timeFrame: baseline up to 61 weeks
measure: Overall survival
timeFrame: baseline up to 61 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Hospital Carl Gustav Carus, MK I
state: Saxony
city: Berlin
country: Germany
facility: Charité
city: Hannover
country: Germany
facility: Hannover Medical School
city: Koeln
country: Germany
facility: University Hospital Koeln
city: Mannheim
country: Germany
facility: University Medical Centre Mannheim
city: Muenster
country: Germany
facility: University Hospital Muenster
city: Tuebingen
country: Germany
facility: University Hospital Tuebingen
Study officials:
affiliation: University Hospital Carl Gustav Carus, Dresden
name: Markus Schuler, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.