A multi-method approach to selecting PRO-CTCAE symptoms for patient-reported outcome in women with endometrial or ovarian cancer undergoing chemotherapy.
Chemotherapy
Endometrial cancer
Item selection
Ovarian cancer
PRO
PRO-CTCAE library
Patient-reported outcomes
Journal
Journal of patient-reported outcomes
ISSN: 2509-8020
Titre abrégé: J Patient Rep Outcomes
Pays: Germany
ID NLM: 101722688
Informations de publication
Date de publication:
18 07 2023
18 07 2023
Historique:
received:
10
01
2023
accepted:
05
07
2023
medline:
21
7
2023
pubmed:
18
7
2023
entrez:
18
7
2023
Statut:
epublish
Résumé
Women with endometrial or ovarian cancer experience a variety of symptoms during chemotherapy. Patient-Reported outcomes (PROs) can provide insight into the symptoms they experience. A PRO tool tailored to this patient population can help accurately monitor adverse events and manage symptoms. The objective of this study was to identify items in the National Cancer Institute's measurement system Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) appropriate for use in a PRO tool for a population of women with endometrial or ovarian cancer undergoing treatment with taxanes (paclitaxel or docetaxel) in combination with carboplatin. A two-phase, sequential multi-methods approach was applied. In phase one, a comprehensive literature search was done to map the toxicity of the applied chemotherapeutics and phase III clinical studies. Phase two, which comprised selecting the PRO-CTCAE items, included discussions with and feedback from a patient advisory board, an additional literature search, and focus group interviews with senior oncologists and specialized oncology nurses. A national expert panel facilitated both phases in terms of carefully select items from the PRO-CTCAE library. Phase one identified 18 symptoms and phase two, three additional ones, leading to the inclusion of 21 PRO-CTCAE symptoms in the final PRO tool. Since PRO-CTCAE also contains one to three sub-questions on the frequency, severity, and interference with daily activities of symptoms, there were 44 potential items. This study describes taking a multi-method approach to selecting items from the PRO-CTCAE library for use in a population of women with endometrial or ovarian cancer undergoing chemotherapy. By systematically combining diverse approaches, we carefully selected 21 clinically relevant symptoms covered by 44 items in the PRO-CTCAE library. Future studies should investigate the psychometric properties of this PRO tool for women with endometrial or ovarian cancer.
Sections du résumé
BACKGROUND
Women with endometrial or ovarian cancer experience a variety of symptoms during chemotherapy. Patient-Reported outcomes (PROs) can provide insight into the symptoms they experience. A PRO tool tailored to this patient population can help accurately monitor adverse events and manage symptoms. The objective of this study was to identify items in the National Cancer Institute's measurement system Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE®) appropriate for use in a PRO tool for a population of women with endometrial or ovarian cancer undergoing treatment with taxanes (paclitaxel or docetaxel) in combination with carboplatin.
METHODS
A two-phase, sequential multi-methods approach was applied. In phase one, a comprehensive literature search was done to map the toxicity of the applied chemotherapeutics and phase III clinical studies. Phase two, which comprised selecting the PRO-CTCAE items, included discussions with and feedback from a patient advisory board, an additional literature search, and focus group interviews with senior oncologists and specialized oncology nurses. A national expert panel facilitated both phases in terms of carefully select items from the PRO-CTCAE library.
RESULTS
Phase one identified 18 symptoms and phase two, three additional ones, leading to the inclusion of 21 PRO-CTCAE symptoms in the final PRO tool. Since PRO-CTCAE also contains one to three sub-questions on the frequency, severity, and interference with daily activities of symptoms, there were 44 potential items.
CONCLUSIONS
This study describes taking a multi-method approach to selecting items from the PRO-CTCAE library for use in a population of women with endometrial or ovarian cancer undergoing chemotherapy. By systematically combining diverse approaches, we carefully selected 21 clinically relevant symptoms covered by 44 items in the PRO-CTCAE library. Future studies should investigate the psychometric properties of this PRO tool for women with endometrial or ovarian cancer.
Identifiants
pubmed: 37462855
doi: 10.1186/s41687-023-00611-w
pii: 10.1186/s41687-023-00611-w
pmc: PMC10354345
doi:
Types de publication
Clinical Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
72Informations de copyright
© 2023. The Author(s).
Références
Sex Med. 2019 Dec;7(4):530-539
pubmed: 31501030
JAMA. 2022 Jun 28;327(24):2413-2422
pubmed: 35661856
J Natl Cancer Inst. 2003 Sep 3;95(17):1320-9
pubmed: 12953086
J Natl Cancer Inst. 2014 Sep 29;106(9):
pubmed: 25265940
J Hum Lact. 2020 Nov;36(4):579-581
pubmed: 32813616
BMJ. 2017 Aug 2;358:j3453
pubmed: 28768629
J Public Health (Oxf). 2018 Sep 1;40(3):e388-e395
pubmed: 29385513
Am J Obstet Gynecol. 2022 Jan;226(1):90.e1-90.e20
pubmed: 34400137
J Pain Symptom Manage. 2016 Aug;52(2):292-7
pubmed: 27090851
Patient Educ Couns. 2022 Jul;105(7):1761-1782
pubmed: 34865888
Patient. 2020 Apr;13(2):189-200
pubmed: 31691205
J Natl Cancer Inst. 2014 Jul 08;106(7):
pubmed: 25006190
J Patient Rep Outcomes. 2021 Jun 23;5(1):47
pubmed: 34160732
Eur J Cancer. 2017 Jun;78:133-138
pubmed: 28448857
Acta Oncol. 2020 Jun;59(6):611-612
pubmed: 32253960
J Natl Cancer Inst. 2004 Nov 17;96(22):1682-91
pubmed: 15547181
Anticancer Res. 2017 Aug;37(8):4005-4015
pubmed: 28739682
Support Care Cancer. 2022 Mar;30(3):2891-2900
pubmed: 34595604
Gynecol Oncol. 2018 Sep;150(3):487-493
pubmed: 30037492
Lancet. 2019 Mar 23;393(10177):1240-1253
pubmed: 30910306
JCO Clin Cancer Inform. 2018 Dec;2:1-12
pubmed: 30652585
Support Care Cancer. 2017 Nov;25(11):3457-3464
pubmed: 28634657
Cancer Nurs. 2022 Jan-Feb 01;45(1):E27-E35
pubmed: 32649337
CA Cancer J Clin. 2021 May;71(3):209-249
pubmed: 33538338
Ann Oncol. 2017 Nov 1;28(suppl_8):viii36-viii39
pubmed: 29232473
Acta Oncol. 2019 May;58(5):596-602
pubmed: 30702003
Breast J. 2019 Mar;25(2):269-272
pubmed: 30761667
Front Oncol. 2021 Apr 29;11:642382
pubmed: 33996556
Cancers (Basel). 2020 Nov 07;12(11):
pubmed: 33171791
J Clin Oncol. 2016 Feb 20;34(6):557-65
pubmed: 26644527
J Patient Rep Outcomes. 2019 Mar 21;3(1):19
pubmed: 30900035
Qual Life Res. 2018 Jan;27(1):59-74
pubmed: 29248998
J Sleep Res. 2022 Jun;31(3):e13510
pubmed: 34716629
Gynecol Oncol. 2021 Apr;161(1):264-274
pubmed: 33516528
Gynecol Oncol. 2022 Feb;164(2):437-445
pubmed: 34955238
J Patient Rep Outcomes. 2019 Aug 22;3(1):56
pubmed: 31440865
BMJ Open. 2015 Nov 30;5(11):e007618
pubmed: 26621509
Int J Gynecol Cancer. 2014 Jun;24(5):865-73
pubmed: 24844220
Int J Clin Oncol. 2019 Jan;24(1):103-114
pubmed: 30030657
Nat Rev Clin Oncol. 2017 Dec;14(12):763-772
pubmed: 28975931
JAMA Oncol. 2015 Nov;1(8):1051-9
pubmed: 26270597
J Oncol Pharm Pract. 2017 Jan;23(1):56-67
pubmed: 26811404
J Clin Oncol. 2021 Mar 1;39(7):734-747
pubmed: 33417506
Patient Relat Outcome Meas. 2021 Feb 16;12:33-43
pubmed: 33623464
J Natl Cancer Inst. 2014 Jul 08;106(7):
pubmed: 25006191
Lancet Oncol. 2022 Aug;23(8):e374-e384
pubmed: 35901833
Int J Gynecol Cancer. 2020 Feb;30(2):252-260
pubmed: 31915136
Am J Obstet Gynecol. 2017 Oct;217(4):395-403
pubmed: 28411144
Gynecol Oncol. 2005 Nov;99(2):404-11
pubmed: 16112174
Gynecol Oncol. 2021 Mar;160(3):817-826
pubmed: 33516529
Ann Oncol. 2022 Sep;33(9):878-892
pubmed: 35462007
JAMA. 2017 Jul 11;318(2):197-198
pubmed: 28586821
BMC Cancer. 2022 Jul 2;22(1):726
pubmed: 35780095
Int J Gynecol Cancer. 2021 Jan;31(1):12-39
pubmed: 33397713
Semin Oncol Nurs. 2019 Apr;35(2):211-216
pubmed: 30871843
J Clin Oncol. 2003 Sep 1;21(17):3194-200
pubmed: 12860964
Arch Gynecol Obstet. 2021 Sep;304(3):791-805
pubmed: 33847794
Int J Gynecol Cancer. 2015 Nov;25(9):1599-607
pubmed: 26397157
Semin Radiat Oncol. 2003 Jul;13(3):176-81
pubmed: 12903007
Prev Med. 2023 Feb;167:107412
pubmed: 36592674
Clin Trials. 2021 Feb;18(1):104-114
pubmed: 33258687
Qual Health Res. 2016 Nov;26(13):1753-1760
pubmed: 26613970