{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,10]],"date-time":"2026-07-10T13:33:40Z","timestamp":1783690420392,"version":"3.55.0"},"reference-count":40,"publisher":"BMJ","issue":"8","license":[{"start":{"date-parts":[[2020,8,27]],"date-time":"2020-08-27T00:00:00Z","timestamp":1598486400000},"content-version":"unspecified","delay-in-days":26,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100013119","name":"PharmaMar","doi-asserted-by":"publisher","award":["This work was supported by an unrestricted grant f"],"award-info":[{"award-number":["This work was supported by an unrestricted grant f"]}],"id":[{"id":"10.13039\/501100013119","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2020,6,9]]},"published-print":{"date-parts":[[2020,8]]},"abstract":"<jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Design<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Participants<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Primary and secondary outcome measures<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      After 9 weeks of treatment, QoL declined less in the IA (\u0394FACT-G total score: \u22122.4, 95% CI: \u22129.2 to 4.5) as compared with CA (\u0394FACT-G total score: \u22123.9; 95% CI:\u221211.3 to 3.5; p\n                      <jats:italic>=<\/jats:italic>\n                      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\n                      <jats:italic>=<\/jats:italic>\n                      0.110). QoL was predicted by symptom severity, symptom interference, depression and anxiety.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      ClinicalTrials.gov Identifier (\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" specific-use=\"clinicaltrial results\" xlink:href=\"NCT02204111\">NCT02204111<\/jats:ext-link>\n                      ).\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2019-035546","type":"journal-article","created":{"date-parts":[[2020,8,28]],"date-time":"2020-08-28T03:23:56Z","timestamp":1598585036000},"page":"e035546","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":12,"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)"],"prefix":"10.1136","volume":"10","clinical-trial-number":[{"clinical-trial-number":"nct02204111","registry":"10.18810\/clinical-trials-gov","type":"results"},{"clinical-trial-number":"nct02204111","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5792-2079","authenticated-orcid":false,"given":"Leopold","family":"Hentschel","sequence":"first","affiliation":[{"name":"Department of Psychooncology of the University Cancer Center (NCT\/UCC), University Hospital Carl Gustav Carus, Dresden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephan","family":"Richter","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hans-Georg","family":"Kopp","sequence":"additional","affiliation":[{"name":"Interdisciplinary Center for Soft-Tissue-Sarcoma, GIST and Bone-Tumor, Robert-Bosch-Center of Tumor Diseases, Stuttgart, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernd","family":"Kasper","sequence":"additional","affiliation":[{"name":"Sarcoma Unit, Interdisciplinary Tumor Center, University Medical Center Mannheim, Medical Faculty Mannheim, University of Heidelberg, Mannheim, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Annegret","family":"Kunitz","sequence":"additional","affiliation":[{"name":"Internal Medicine, Vivantes Clinic Spandau, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Viktor","family":"Gr\u00fcnwald","sequence":"additional","affiliation":[{"name":"Interdisciplinary Genitourinary Oncology\/West-German Cancer Center, University Hospital Essen, Essen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Torsten","family":"Kessler","sequence":"additional","affiliation":[{"name":"Hematology Oncology, University Hospital of M\u00fcnster, M\u00fcnster, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jens Marcus","family":"Chemnitz","sequence":"additional","affiliation":[{"name":"Internal Medicine, ev. Stift St. Martin, Koblenz, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Uwe","family":"Pelzer","sequence":"additional","affiliation":[{"name":"Division of Hematology, Oncology and Tumor Immunology, Charit\u00e9 Medical University, Berlin, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ulrich","family":"Schuler","sequence":"additional","affiliation":[{"name":"University Palliative Center, University Hospital Carl Gustav Carus, Dresden, Sachsen, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Janet","family":"Freitag","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine I, University Hospital Carl Gustav Carus, Dresden, Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea","family":"Schilling","sequence":"additional","affiliation":[{"name":"Department of Social Work, University Hospital Carl Gustav Carus, Dresden, Sachsen, 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