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

NCT02204111 | Completed

• 1 other identifier: YonLife-2014
• Study Type: observational
• Target: 77
• Locations: 1 country
• Sites: 7

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.

Conditions

Soft Tissue Sarcoma

Keywords

Palliative Treatment; Trabectedin; Patient Reported Outcome

Outcome Measures

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

  change to baseline at 9 weeks

Secondary Outcomes (8)

• Dimensions of QoL (scales of FACT-G)

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

• Anxiety and depression (HADS)

  baseline, 9, 21, 35 and 61 weeks

• Satisfaction with care (IN-PATSAT32)

  baseline, 9, 21, 35 and 61 weeks

• Anorexia and cachexia related impact on QoL (FAACT)

  baseline, 9, 21, 35 and 61 weeks

• Intensity of pain and pain related interference (BPI)

  baseline, 9, 21, 35 and 61 weeks

Study Arms (2)

Control Cluster

Care as usual

Treatment Cluster

Care as usual and patient directed, multidimensional treatment proposals

Other: Intervention

Interventions

Intervention OTHER

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

Treatment Cluster

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Soft Tissue Sarcoma under palliative treatment with Trabectedin

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• GWT-TUD GmbH: lead
• PharmaMar: collaborator

Study Sites (7)

University Hospital Carl Gustav Carus, MK I

Dresden, Saxony, 01307, Germany

Location

Charité

Berlin, 13353, Germany

Location

University Hospital Koeln

Cologne, 50937, Germany

Location

Hannover Medical School

Hanover, 30625, Germany

Location

University Medical Centre Mannheim

Mannheim, 68167, Germany

Location

University Hospital Muenster

Münster, 48149, Germany

Location

University Hospital Tuebingen

Tübingen, 72076, Germany

Location

Related Publications (2)

• 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.

  PMID: 32859662 DERIVED

• 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.

  PMID: 28667207 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Methods

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Markus Schuler, Dr. med.

  University Hospital Carl Gustav Carus, Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 30, 2014
• Study Start: September 1, 2014
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: November 8, 2018

Record last verified: 2018-11

Locations

DE (7)