Multicenter Prospective Cohort Study of the Patient-Reported Outcome Measures PRO-CTCAE and CAT EORTC QLQ-C30 in Major Abdominal Cancer Surgery (PATRONUS): A Student-Initiated German Medical Audit (SIGMA) Study

  1. Mihaljevic, André
  2. Fink, Christopher
  3. Frey, Pia
  4. Friedrich, Mirco
  5. Leuck, Alexander
  6. Rädeker, Lukas
  7. Schwab, Marius
  8. Doerr-Harim, Colette
  9. Tenckhoff, Solveig
  10. Feißt, Manuel
  11. Faqar-Uz-Zaman, Sara Fatima
  12. Brindl, Niall
  13. Tu, Thomas Jing Zhi
  14. Studier-Fischer, Alexander
  15. Kuner, Charlotte
  16. Gsenger, Julia
  17. Möhwald, Clara
  18. Prem, Markus
  19. Von der Waydbrink, Henriette
  20. Tielking, Katharina
  21. Rahbari, Mohammad
  22. Bertram, Boortz
  23. Neudecker, Jens
  24. Jörke, Linda
  25. Findeisen, Lisa
  26. Fichtel, Pascal
  27. Bigge, Richard
  28. Nuh, Rahbari
  29. Bork, Ulrich
  30. Klein, Adele
  31. Stojanovich, Strahin
  32. Schnitzbauer, Andreas A.
  33. Vorbach, Samuel
  34. Braune, Jan
  35. Scholz, Alexander
  36. Kreifels, Paul
  37. Zell, Daniel
  38. Van de Lo, Tim
  39. Holzner, Philipp
  40. Martini, Verena
  41. Hinz, Nico
  42. Finger, Anna Ekaterina
  43. Kokaly, Nadia
  44. Kosch, Ricardo
  45. Piel, Sharlaine Yun Lan
  46. Tachezy, Michael
  47. Gablenz, Eva
  48. Alhalabi, Obada T.
  49. Sliwinski, Svenja
  50. Marx, Alexander
  51. AuYeung, Annette
  52. Achilles, Christina
  53. Betge, Fynn
  54. Kühn, Jana
  55. Al Halabi, Karam
  56. von Fritsch-Seerhausen, Lennart
  57. Beck, Lydia
  58. Truant, Marc
  59. Preuß, Sophie
  60. Waider, Stella
  61. Seiboldt, Till
  62. Sander, Anja
  63. Honecker, Hannah
  64. Seide, Svenja
  65. Weber, Dorothea
  66. Büsch, Christopher
  67. Wagner, Florian
  68. Reckmann, Lisa
  69. Sonnenberg, Anna-Maria
  70. Zaczeck, Michael
  71. Buech, Joscha
  72. Luden, Laura
  73. Autenrieb, Marie-Pauline
  74. Taivankhuu, Terbish
  75. Tröster, Desiree
  76. Engster, Simon
  77. Buia, Alexander
  78. Hanisch, Ernst
  79. Müller-Debus, Charlotte
  80. Heinrich, Alexander
  81. Rasel, Hannah
  82. Nergiz, Kartal
  83. Lang, Hauke
  84. Watzka, Felix
  85. Pohl, Laura
  86. Makabe, Akiko Lucia
  87. Seckler, Anna-Maria
  88. Misiraj, Blerina
  89. Kerem, Carmel
  90. Lull, Christian
  91. Voigt, Jonas
  92. Beier, Julian Pascal
  93. Schütze, Leon
  94. Dreyer, Leonhard
  95. Kleinsorge, Marie Therese
  96. Nguyen, Thao
  97. Thäwel, Thomas
  98. Günther, Tobias
  99. Herrle, Florian
  100. Sadeghi, Diana
  101. Scheuerpflug, Anne
  102. Apfelbeck, Antonia
  103. Schömer Cuenca, Sebastian
  104. Albertsmeier, Markus
  105. Zimmermann, Petra
  106. von Ehrlich-Treuenstätt, Viktor
  107. Kopp, Alessia
  108. Schmitzer, Lena
  109. Reim, Daniel
  110. Schirren, Rebekka
  111. Mihaljevic, André ORCID logo

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1000 Titel
  • Multicenter Prospective Cohort Study of the Patient-Reported Outcome Measures PRO-CTCAE and CAT EORTC QLQ-C30 in Major Abdominal Cancer Surgery (PATRONUS): A Student-Initiated German Medical Audit (SIGMA) Study
1000 Autor/in
  1. Mihaljevic, André |
  2. Fink, Christopher |
  3. Frey, Pia |
  4. Friedrich, Mirco |
  5. Leuck, Alexander |
  6. Rädeker, Lukas |
  7. Schwab, Marius |
  8. Doerr-Harim, Colette |
  9. Tenckhoff, Solveig |
  10. Feißt, Manuel |
  11. Faqar-Uz-Zaman, Sara Fatima |
  12. Brindl, Niall |
  13. Tu, Thomas Jing Zhi |
  14. Studier-Fischer, Alexander |
  15. Kuner, Charlotte |
  16. Gsenger, Julia |
  17. Möhwald, Clara |
  18. Prem, Markus |
  19. Von der Waydbrink, Henriette |
  20. Tielking, Katharina |
  21. Rahbari, Mohammad |
  22. Bertram, Boortz |
  23. Neudecker, Jens |
  24. Jörke, Linda |
  25. Findeisen, Lisa |
  26. Fichtel, Pascal |
  27. Bigge, Richard |
  28. Nuh, Rahbari |
  29. Bork, Ulrich |
  30. Klein, Adele |
  31. Stojanovich, Strahin |
  32. Schnitzbauer, Andreas A. |
  33. Vorbach, Samuel |
  34. Braune, Jan |
  35. Scholz, Alexander |
  36. Kreifels, Paul |
  37. Zell, Daniel |
  38. Van de Lo, Tim |
  39. Holzner, Philipp |
  40. Martini, Verena |
  41. Hinz, Nico |
  42. Finger, Anna Ekaterina |
  43. Kokaly, Nadia |
  44. Kosch, Ricardo |
  45. Piel, Sharlaine Yun Lan |
  46. Tachezy, Michael |
  47. Gablenz, Eva |
  48. Alhalabi, Obada T. |
  49. Sliwinski, Svenja |
  50. Marx, Alexander |
  51. AuYeung, Annette |
  52. Achilles, Christina |
  53. Betge, Fynn |
  54. Kühn, Jana |
  55. Al Halabi, Karam |
  56. von Fritsch-Seerhausen, Lennart |
  57. Beck, Lydia |
  58. Truant, Marc |
  59. Preuß, Sophie |
  60. Waider, Stella |
  61. Seiboldt, Till |
  62. Sander, Anja |
  63. Honecker, Hannah |
  64. Seide, Svenja |
  65. Weber, Dorothea |
  66. Büsch, Christopher |
  67. Wagner, Florian |
  68. Reckmann, Lisa |
  69. Sonnenberg, Anna-Maria |
  70. Zaczeck, Michael |
  71. Buech, Joscha |
  72. Luden, Laura |
  73. Autenrieb, Marie-Pauline |
  74. Taivankhuu, Terbish |
  75. Tröster, Desiree |
  76. Engster, Simon |
  77. Buia, Alexander |
  78. Hanisch, Ernst |
  79. Müller-Debus, Charlotte |
  80. Heinrich, Alexander |
  81. Rasel, Hannah |
  82. Nergiz, Kartal |
  83. Lang, Hauke |
  84. Watzka, Felix |
  85. Pohl, Laura |
  86. Makabe, Akiko Lucia |
  87. Seckler, Anna-Maria |
  88. Misiraj, Blerina |
  89. Kerem, Carmel |
  90. Lull, Christian |
  91. Voigt, Jonas |
  92. Beier, Julian Pascal |
  93. Schütze, Leon |
  94. Dreyer, Leonhard |
  95. Kleinsorge, Marie Therese |
  96. Nguyen, Thao |
  97. Thäwel, Thomas |
  98. Günther, Tobias |
  99. Herrle, Florian |
  100. Sadeghi, Diana |
  101. Scheuerpflug, Anne |
  102. Apfelbeck, Antonia |
  103. Schömer Cuenca, Sebastian |
  104. Albertsmeier, Markus |
  105. Zimmermann, Petra |
  106. von Ehrlich-Treuenstätt, Viktor |
  107. Kopp, Alessia |
  108. Schmitzer, Lena |
  109. Reim, Daniel |
  110. Schirren, Rebekka |
  111. Mihaljevic, André |
1000 Erscheinungsjahr 2021
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2021-03-08
1000 Erschienen in
1000 Quellenangabe
  • 28(6):3075-3089
1000 Copyrightjahr
  • 2021
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1245/s10434-021-09646-z |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8119276/ |
1000 Publikationsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • Background!#!The patient-reported outcomes (PRO) version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) and the computerized adaptive testing (CAT) version of the EORTC quality-of-life questionnaire QLQ-C30 have been proposed as new PRO measures in oncology; however, their implementation in patients undergoing cancer surgery has not yet been evaluated.!##!Methods!#!Patients undergoing elective abdominal cancer surgery were enrolled in a prospective multicenter study, and postoperative complications were recorded according to the Dindo-Clavien classification. Patients reported PRO data using the CAT EORTC QLQ-C30 and the PRO-CTCAE to measure 12 core cancer symptoms. Patients were followed-up for 6 months postoperatively. The study was carried out by medical students of the CHIR-Net SIGMA study network.!##!Results!#!Data of 303 patients were obtained and analyzed across 15 sites. PRO-CTCAE symptoms 'poor appetite', 'fatigue', 'exhaustion' and 'sleeping problems' increased after surgery and climaxed 10-30 days postoperatively. At 3-6 months postoperatively, no PRO-CTCAE symptom differed significantly to baseline. Patients reported higher 'social functioning' (p = 0.021) and overall quality-of-life scores (p < 0.05) 6 months after cancer surgery compared with the baseline level. There was a lack of correlation between postoperative complications or death and any of the PRO items evaluated. Feasibility endpoints for student-led research were met.!##!Conclusion!#!The two novel PRO questionnaires were successfully applied in surgical oncology. Postoperative complications do not affect health-reported quality-of-life or common cancer symptoms following major cancer surgery. The feasibility of student-led multicenter clinical research was demonstrated, but might be enhanced by improved student training.
1000 Sacherschließung
lokal Surgical Oncology
lokal Surveys and Questionnaires [MeSH]
lokal Neoplasms [MeSH]
lokal Global Health Services Research
lokal Quality of Life [MeSH]
lokal Humans [MeSH]
lokal Prospective Studies [MeSH]
lokal Medical Audit [MeSH]
lokal Students [MeSH]
lokal Surgery
lokal Oncology
lokal Patient Reported Outcome Measures [MeSH]
1000 Liste der Beteiligten
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