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)
Objectives The choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge regarding efficacy, quality of life (QoL) and toxicity. Unlike other cancer types, where integrating patient-reported outcomes (PRO) has proven to be beneficial for QoL, there is no such evidenc...
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BMJ Publishing Group
2020-08-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/10/8/e035546.full |
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| author | Bernd Kasper Viktor Grünwald Martin Bornhäuser Uwe Pelzer Leopold Hentschel Stephan Richter Hans-Georg Kopp Annegret Kunitz Torsten Kessler Jens Marcus Chemnitz Ulrich Schuler Janet Freitag Andrea Schilling Beate Hornemann Karin Arndt Markus Kajo Schuler |
| author_facet | Bernd Kasper Viktor Grünwald Martin Bornhäuser Uwe Pelzer Leopold Hentschel Stephan Richter Hans-Georg Kopp Annegret Kunitz Torsten Kessler Jens Marcus Chemnitz Ulrich Schuler Janet Freitag Andrea Schilling Beate Hornemann Karin Arndt Markus Kajo Schuler |
| author_sort | Bernd Kasper |
| collection | DOAJ |
| description | Objectives The choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge regarding efficacy, quality of life (QoL) and toxicity. Unlike other cancer types, where integrating patient-reported outcomes (PRO) has proven to be beneficial for QoL, there is no such evidence in patients with STS as of now. The YonLife trial aimed to explore the effect of a tailored multistep intervention on QoL, symptoms and survival in patients with advanced STS undergoing treatment with trabectedin as well as identifying predictors of QoL.Design YonLife is a cluster-randomised, open-label, proof-of-concept study. The intervention incorporates electronic PRO assessment, a case vignette and expert-consented treatment recommendations.Participants Six hospitals were randomised to the control arm (CA) or interventional arm (IA). Seventy-nine patients were included of whom 40 were analysed as per-protocol analysis set.Primary and secondary outcome measures The primary end point was the change of Functional Assessment for Cancer Therapy (FACT-G) total score after 9 weeks. Secondary outcomes included QoL (FACT-G subscales), anorexia and cachexia (Functional Assessment of Anorexia/Cachexia Therapy (FAACT)), symptoms (MD Anderson Symptom Inventory (MDASI)), anxiety and depression (HADS), pain intensity and interference (Brief Pain Inventory (BPI)) and survival assessment.Results After 9 weeks of treatment, QoL declined less in the IA (ΔFACT-G total score: −2.4, 95% CI: −9.2 to 4.5) as compared with CA (ΔFACT-G total score: −3.9; 95% CI:−11.3 to 3.5; p=0.765). In almost all FACT-G subscales, average declines were lower in IA, but without reaching statistical significance. Smaller adverse trends between arms were observed for MDASI, FAACT, HADS and BPI scales. These trends failed to reach statistical significance. Overall mean survival was longer in IA (648 days) than in CA (389 days, p=0.110). QoL was predicted by symptom severity, symptom interference, depression and anxiety.Conclusion Our data suggest a potentially favourable effect of an electronic patient-reported outcomes based intervention on QoL that needs to be reappraised in confirmatory studies.Trial registration number ClinicalTrials.gov Identifier (NCT02204111). |
| format | Article |
| id | doaj-art-f3c2c2a7e5d2423190db0bef5a6cb53c |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2020-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-f3c2c2a7e5d2423190db0bef5a6cb53c2024-12-02T00:00:09ZengBMJ Publishing GroupBMJ Open2044-60552020-08-0110810.1136/bmjopen-2019-035546Quality 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)Bernd Kasper0Viktor Grünwald1Martin Bornhäuser2Uwe Pelzer3Leopold Hentschel4Stephan Richter5Hans-Georg Kopp6Annegret Kunitz7Torsten Kessler8Jens Marcus Chemnitz9Ulrich Schuler10Janet Freitag11Andrea Schilling12Beate Hornemann13Karin Arndt14Markus Kajo Schuler15Sarcoma Unit, Interdisciplinary Tumor Center, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, GermanyDepartment of Medical Oncology, West German Cancer Center, University Hospital Essen, Essen, GermanyDepartment of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, GermanyDepartment of Hematology, Oncology and Tumorimmunology, Charite Universitatsmedizin Berlin, Berlin, GermanyDepartment of Psychooncology of the University Cancer Center (NCT/UCC), University Hospital Carl Gustav Carus, Dresden, GermanyDepartment of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, GermanyInterdisciplinary Center for Soft-Tissue-Sarcoma, GIST and Bone-Tumor, Robert-Bosch-Center of Tumor Diseases, Stuttgart, GermanyInternal Medicine, Vivantes Clinic Spandau, Berlin, GermanyHematology Oncology, University Hospital of Münster, Münster, GermanyInternal Medicine, ev. Stift St. Martin, Koblenz, GermanyUniversity Palliative Center, University Hospital Carl Gustav Carus, Dresden, Sachsen, GermanyDepartment of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, GermanyDepartment of Social Work, University Hospital Carl Gustav Carus, Dresden, Sachsen, GermanyDepartment of Psychooncology of the University Cancer Center (NCT/UCC), University Hospital Carl Gustav Carus, Dresden, GermanyPatient Advocacy, Das Lebenshaus e.V, Wölfersheim, GermanyDepartment of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, GermanyObjectives The choice of drug treatment in advanced soft tissue sarcoma (STS) continues to be a challenge regarding efficacy, quality of life (QoL) and toxicity. Unlike other cancer types, where integrating patient-reported outcomes (PRO) has proven to be beneficial for QoL, there is no such evidence in patients with STS as of now. The YonLife trial aimed to explore the effect of a tailored multistep intervention on QoL, symptoms and survival in patients with advanced STS undergoing treatment with trabectedin as well as identifying predictors of QoL.Design YonLife is a cluster-randomised, open-label, proof-of-concept study. The intervention incorporates electronic PRO assessment, a case vignette and expert-consented treatment recommendations.Participants Six hospitals were randomised to the control arm (CA) or interventional arm (IA). Seventy-nine patients were included of whom 40 were analysed as per-protocol analysis set.Primary and secondary outcome measures The primary end point was the change of Functional Assessment for Cancer Therapy (FACT-G) total score after 9 weeks. Secondary outcomes included QoL (FACT-G subscales), anorexia and cachexia (Functional Assessment of Anorexia/Cachexia Therapy (FAACT)), symptoms (MD Anderson Symptom Inventory (MDASI)), anxiety and depression (HADS), pain intensity and interference (Brief Pain Inventory (BPI)) and survival assessment.Results After 9 weeks of treatment, QoL declined less in the IA (ΔFACT-G total score: −2.4, 95% CI: −9.2 to 4.5) as compared with CA (ΔFACT-G total score: −3.9; 95% CI:−11.3 to 3.5; p=0.765). In almost all FACT-G subscales, average declines were lower in IA, but without reaching statistical significance. Smaller adverse trends between arms were observed for MDASI, FAACT, HADS and BPI scales. These trends failed to reach statistical significance. Overall mean survival was longer in IA (648 days) than in CA (389 days, p=0.110). QoL was predicted by symptom severity, symptom interference, depression and anxiety.Conclusion Our data suggest a potentially favourable effect of an electronic patient-reported outcomes based intervention on QoL that needs to be reappraised in confirmatory studies.Trial registration number ClinicalTrials.gov Identifier (NCT02204111).https://bmjopen.bmj.com/content/10/8/e035546.full |
| spellingShingle | Bernd Kasper Viktor Grünwald Martin Bornhäuser Uwe Pelzer Leopold Hentschel Stephan Richter Hans-Georg Kopp Annegret Kunitz Torsten Kessler Jens Marcus Chemnitz Ulrich Schuler Janet Freitag Andrea Schilling Beate Hornemann Karin Arndt Markus Kajo Schuler 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 |
| title | 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) |
| title_full | 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) |
| title_fullStr | 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) |
| title_full_unstemmed | 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) |
| title_short | 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) |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/10/8/e035546.full |
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