Department of IQ Health, Radboud University Medical Center, Postbus 9101, 6500 HB, Nijmegen, The Netherlands.
Department of Radiation Oncology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.
Qual Life Res. 2024 Nov;33(11):3013-3026. doi: 10.1007/s11136-024-03767-0. Epub 2024 Sep 8.
Standardized patient-reported outcomes (PRO) monitoring during and after rectal cancer treatment provides insight into treatment-related toxicities patients experience and improves health-related quality-of-life as well as overall survival. We aimed to select a subset of the PRO version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) for standardized monitoring of treatment-related symptomatic toxicities in rectal cancer.
We used a mixed methods approach including a literature review, and semi-structured interviews with health care providers (HCPs) involved in rectal cancer care and rectal cancer patients. Results from literature and interviews were summarized and used in a modified Delphi procedure to select a PRO-CTCAE subset specific for rectal cancer.
Twenty-six PRO-CTCAE symptomatic toxicities were identified from literature. Fifteen HCPs from multiple disciplines (medical, radiation and surgical oncology), and a heterogeneous group of fifteen rectal cancer patients treated with chemotherapy and/or radiotherapy and/or surgery, participated in semi-structured interviews. Ten HCPs (67%) and nine patients (90%) participated in the first Delphi round. The final selected PRO-CTCAE core-subset contained 16 symptomatic toxicities: 'diarrhea', 'fecal incontinence', 'constipation','bloating of the abdomen', 'pain in the abdomen', 'vomiting', 'decreased libido', 'pain during vaginal sex', 'ability to achieve and maintain erection', 'fatigue', 'anxiety', 'feeling that nothing could cheer you up', 'urinary incontinence', 'painful urination', 'general pain', and 'hand-foot syndrome'.
Based on a comprehensive mixed methods study, a PRO-CTCAE subset for standardized treatment-related symptomatic toxicity monitoring in rectal cancer was identified. Assessment of the effectiveness and compliance of symptomatic toxicity monitoring using this subset is recommended.
在直肠癌治疗期间和之后进行标准化的患者报告结局（PRO）监测，可以深入了解患者所经历的与治疗相关的毒性，改善健康相关生活质量和总体生存率。我们旨在选择 PRO 版常见不良事件术语标准（PRO-CTCAE）的一个子集，用于标准化监测直肠癌治疗相关的症状性毒性。
我们采用混合方法，包括文献回顾和参与直肠癌治疗的医疗保健提供者（HCP）的半结构化访谈，以及直肠癌患者。总结文献和访谈的结果，并用于改良 Delphi 程序，以选择特定于直肠癌的 PRO-CTCAE 子集。
从文献中确定了 26 种 PRO-CTCAE 症状性毒性。来自多个学科（医学、放射和外科肿瘤学）的 15 名 HCP 以及接受化疗和/或放疗和/或手术治疗的 15 名异质性直肠癌患者参与了半结构化访谈。10 名 HCP（67%）和 9 名患者（90%）参加了第一轮 Delphi 调查。最终选择的 PRO-CTCAE 核心子集包含 16 种症状性毒性：“腹泻”、“粪便失禁”、“便秘”、“腹胀”、“腹痛”、“呕吐”、“性欲降低”、“阴道性交时疼痛”、“达到和维持勃起的能力”、“疲劳”、“焦虑”、“感觉什么都提不起精神”、“尿失禁”、“尿痛”、“一般性疼痛”和“手足综合征”。
基于全面的混合方法研究，确定了用于标准化直肠癌治疗相关症状性毒性监测的 PRO-CTCAE 子集。建议评估使用该子集进行症状性毒性监测的有效性和依从性。
