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| Name | Class |
|---|---|
| PharmaMar | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Cluster | Care as usual | ||
| Treatment Cluster | Care as usual and patient directed, multidimensional treatment proposals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention | Other | Individualized treatment proposals (e.g. pain therapy, physiotherapy, psychological contact) from expert consensus, based on Patient Reported Outcomes |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dimensions of QoL (scales of FACT-G) | assessed by the patient using standard questionnaire (FACT-G) via tablet-PC | baseline, 3, 6, 9, 21, 35 and 61 weeks |
| Anxiety and depression (HADS) | assessed by the patient using standard questionnaire (HADS) via tablet-PC |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Soft Tissue Sarcoma under palliative treatment with Trabectedin
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| Name | Affiliation | Role |
|---|---|---|
| Markus Schuler, Dr. med. | University Hospital Carl Gustav Carus, Dresden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Carl Gustav Carus, MK I | Dresden | Saxony | 01307 | Germany | ||
| Charité |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32859662 | Derived | 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. | |
| 28667207 |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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| baseline, 9, 21, 35 and 61 weeks |
| Satisfaction with care (IN-PATSAT32) | assessed by the patient using standard questionnaire (IN-PATSAT32) via tablet-PC | 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 | 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 | baseline, 9, 21, 35 and 61 weeks |
| Severity of cancer-related symptoms (MDASI) | assessed by the patient using standard questionnaire (MDASI) via tablet-PC | baseline, 3, 6, 9, 21, 35 and 61 weeks |
| progression free survival | baseline up to 61 weeks |
| Overall survival | baseline up to 61 weeks |
| Berlin |
| 13353 |
| Germany |
| University Hospital Koeln | Cologne | 50937 | Germany |
| Hannover Medical School | Hanover | 30625 | Germany |
| University Medical Centre Mannheim | Mannheim | 68167 | Germany |
| University Hospital Muenster | Münster | 48149 | Germany |
| University Hospital Tuebingen | Tübingen | 72076 | Germany |
| 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. |