Department of Oncology, Centre for Cancer and Organ Diseases, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
J Patient Rep Outcomes. 2023 Jul 18;7(1):72. doi: 10.1186/s41687-023-00611-w.
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.
患有子宫内膜癌或卵巢癌的女性在化疗过程中会经历各种症状。患者报告的结局（PROs）可以深入了解她们所经历的症状。针对这一特定患者群体量身定制的 PRO 工具可以帮助准确监测不良反应事件并管理症状。本研究的目的是确定美国国家癌症研究所的测量系统患者报告结局版通用术语标准不良反应事件（PRO-CTCAE®）中的项目，这些项目适用于接受紫杉醇或多西他赛联合卡铂化疗的子宫内膜癌或卵巢癌患者的 PRO 工具。
采用两阶段、顺序多方法方法。第一阶段，进行了全面的文献检索，以绘制应用化疗药物的毒性和 III 期临床试验图谱。第二阶段，包括选择 PRO-CTCAE 项目，包括与患者顾问委员会的讨论和反馈、额外的文献检索以及与高级肿瘤学家和专门的肿瘤护士的焦点小组访谈。一个国家专家小组在从 PRO-CTCAE 库中仔细选择项目方面为两个阶段提供了便利。
第一阶段确定了 18 种症状，第二阶段又确定了另外 3 种症状，导致最终 PRO 工具中纳入了 21 种 PRO-CTCAE 症状。由于 PRO-CTCAE 还包含一个到三个关于症状频率、严重程度和对日常活动干扰的子问题，因此共有 44 个潜在项目。
本研究描述了采用多方法方法从 PRO-CTCAE 库中选择项目用于接受化疗的子宫内膜癌或卵巢癌患者的方法。通过系统地结合多种方法，我们仔细选择了 PRO-CTCAE 库中 44 个项目涵盖的 21 种临床相关症状。未来的研究应调查针对子宫内膜癌或卵巢癌女性的这种 PRO 工具的心理测量特性。
