PRO头发安全研究:患者对头皮冷却对头发保存影响的看法。

IF 3.3 4区 医学 Q2 ONCOLOGY
Christine Brunner, Daniel Egle, Magdalena Ritter, Ricarda Kofler, Johannes M Giesinger, Lisa Schneitter, Monika Sztankay, Miriam Emmelheinz, Samira Abdel Azim, Verena Wieser, Anne Oberguggenberger
{"title":"PRO头发安全研究:患者对头皮冷却对头发保存影响的看法。","authors":"Christine Brunner,&nbsp;Daniel Egle,&nbsp;Magdalena Ritter,&nbsp;Ricarda Kofler,&nbsp;Johannes M Giesinger,&nbsp;Lisa Schneitter,&nbsp;Monika Sztankay,&nbsp;Miriam Emmelheinz,&nbsp;Samira Abdel Azim,&nbsp;Verena Wieser,&nbsp;Anne Oberguggenberger","doi":"10.2147/BCTT.S412338","DOIUrl":null,"url":null,"abstract":"<p><strong>Purpose: </strong>Alopecia has been reported a distressing side-effect of chemotherapy for breast cancer patients (BCP) that is highly relevant for quality of life during treatment. For the prevention of chemotherapy-induced alopecia, scalp cooling (SC) has been reported to be an effective and safe intervention. However, data on the patient's perspective on effectiveness and applicability of SC in a clinical routine setting are scarce. In this comparative study, we aimed at a longitudinal assessment of patient-reported outcome (PRO) data on the effect of SC on alopecia and its effect on symptoms and functional health when applied in clinical routine in BCP receiving taxane or anthracycline-based chemotherapy.</p><p><strong>Patients and methods: </strong>Study participants were allocated either to the intervention group receiving SC or to the control group based on patient preference (non-randomized study). All patients completed PRO-measures on hair preservation (EORTC Item Library items on hair loss), symptom and functional health measures (EORTC QLQ-C30 and -BR23) and the Body Image Scale (BIS). Outcomes were assessed at chemotherapy start (baseline), mid-chemotherapy, last chemotherapy cycle, 3 months follow-up and 6-9 months follow-up.</p><p><strong>Results: </strong>Overall, we included 113 patients: 75 patients underwent SC (mean age = 51.3 years, 52.7% premenopausal); 38 patients standard care (mean age = 55.6 years, 39.5% premenopausal). A total of 53 patients (70.7%) discontinued SC, with 39 patients (73.5%) stating alopecia as the primary reason. On average, BCP stayed on treatment with the cooling cap for 40.2% of the duration of their chemotherapy (SD 25.3%). In an intention-to-treat analysis, we found no difference between the SC group and the control group with regard to their patient-reported hair loss (<i>p</i>=0.831) across the observation period, overall QOL (<i>p</i>=0.627), emotional functioning (<i>p</i>=0.737), social functioning (<i>p</i>=0.635) and body image (<i>p</i>=0.463) did not differ between groups.</p><p><strong>Conclusion: </strong>We found a high rate of SC-decliners and no beneficial effects of SC for patient-reported hair loss, symptoms and functional health. The efficacy and tolerability of SC applied in a clinical routine setting hence appeared to be limited. The further determination and up-front definition of criteria prognostic for effectiveness of SC may be helpful to identify patient subgroups that may experience a treatment benefit.</p>","PeriodicalId":9106,"journal":{"name":"Breast Cancer : Targets and Therapy","volume":null,"pages":null},"PeriodicalIF":3.3000,"publicationDate":"2023-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/85/82/bctt-15-485.PMC10361405.pdf","citationCount":"0","resultStr":"{\"title\":\"PRO Hair Safe Study: The Patient's Perspective on the Effects of Scalp Cooling on Hair Preservation.\",\"authors\":\"Christine Brunner,&nbsp;Daniel Egle,&nbsp;Magdalena Ritter,&nbsp;Ricarda Kofler,&nbsp;Johannes M Giesinger,&nbsp;Lisa Schneitter,&nbsp;Monika Sztankay,&nbsp;Miriam Emmelheinz,&nbsp;Samira Abdel Azim,&nbsp;Verena Wieser,&nbsp;Anne Oberguggenberger\",\"doi\":\"10.2147/BCTT.S412338\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Purpose: </strong>Alopecia has been reported a distressing side-effect of chemotherapy for breast cancer patients (BCP) that is highly relevant for quality of life during treatment. For the prevention of chemotherapy-induced alopecia, scalp cooling (SC) has been reported to be an effective and safe intervention. However, data on the patient's perspective on effectiveness and applicability of SC in a clinical routine setting are scarce. In this comparative study, we aimed at a longitudinal assessment of patient-reported outcome (PRO) data on the effect of SC on alopecia and its effect on symptoms and functional health when applied in clinical routine in BCP receiving taxane or anthracycline-based chemotherapy.</p><p><strong>Patients and methods: </strong>Study participants were allocated either to the intervention group receiving SC or to the control group based on patient preference (non-randomized study). All patients completed PRO-measures on hair preservation (EORTC Item Library items on hair loss), symptom and functional health measures (EORTC QLQ-C30 and -BR23) and the Body Image Scale (BIS). Outcomes were assessed at chemotherapy start (baseline), mid-chemotherapy, last chemotherapy cycle, 3 months follow-up and 6-9 months follow-up.</p><p><strong>Results: </strong>Overall, we included 113 patients: 75 patients underwent SC (mean age = 51.3 years, 52.7% premenopausal); 38 patients standard care (mean age = 55.6 years, 39.5% premenopausal). A total of 53 patients (70.7%) discontinued SC, with 39 patients (73.5%) stating alopecia as the primary reason. On average, BCP stayed on treatment with the cooling cap for 40.2% of the duration of their chemotherapy (SD 25.3%). In an intention-to-treat analysis, we found no difference between the SC group and the control group with regard to their patient-reported hair loss (<i>p</i>=0.831) across the observation period, overall QOL (<i>p</i>=0.627), emotional functioning (<i>p</i>=0.737), social functioning (<i>p</i>=0.635) and body image (<i>p</i>=0.463) did not differ between groups.</p><p><strong>Conclusion: </strong>We found a high rate of SC-decliners and no beneficial effects of SC for patient-reported hair loss, symptoms and functional health. The efficacy and tolerability of SC applied in a clinical routine setting hence appeared to be limited. The further determination and up-front definition of criteria prognostic for effectiveness of SC may be helpful to identify patient subgroups that may experience a treatment benefit.</p>\",\"PeriodicalId\":9106,\"journal\":{\"name\":\"Breast Cancer : Targets and Therapy\",\"volume\":null,\"pages\":null},\"PeriodicalIF\":3.3000,\"publicationDate\":\"2023-01-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/85/82/bctt-15-485.PMC10361405.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Breast Cancer : Targets and Therapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.2147/BCTT.S412338\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"ONCOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Breast Cancer : Targets and Therapy","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.2147/BCTT.S412338","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0

摘要

目的:据报道,脱发是乳腺癌患者化疗(BCP)的一个令人痛苦的副作用,与治疗期间的生活质量高度相关。为了预防化疗引起的脱发,头皮冷却(SC)已被报道为一种有效和安全的干预措施。然而,关于患者对SC在临床常规环境中的有效性和适用性的看法的数据很少。在这项比较研究中,我们旨在对患者报告的预后(PRO)数据进行纵向评估,评估SC在接受紫杉烷或蒽环类化疗的BCP临床常规应用时对脱发的影响及其对症状和功能健康的影响。患者和方法:研究参与者根据患者偏好被分配到接受SC的干预组或对照组(非随机研究)。所有患者均完成头发保存pro测试(EORTC项目库脱发项目)、症状和功能健康测试(EORTC QLQ-C30和-BR23)和身体形象量表(BIS)。在化疗开始(基线)、化疗中期、最后一个化疗周期、3个月随访和6-9个月随访时评估结果。结果:总的来说,我们纳入了113例患者:75例患者接受了SC(平均年龄= 51.3岁,52.7%绝经前);标准治疗38例(平均年龄55.6岁,39.5%绝经前)。共有53名患者(70.7%)停止使用SC,其中39名患者(73.5%)表示脱发是主要原因。平均而言,BCP在化疗期间使用冷却帽治疗的时间为40.2% (SD为25.3%)。在意向治疗分析中,我们发现SC组和对照组在整个观察期内患者报告的脱发(p=0.831)、总体生活质量(p=0.627)、情绪功能(p=0.737)、社会功能(p=0.635)和身体形象(p=0.463)方面没有差异。结论:我们发现SC的下降率很高,并且SC对患者报告的脱发、症状和功能健康没有有益的影响。因此,SC在临床常规环境中的疗效和耐受性似乎是有限的。进一步确定和预先定义SC有效性的预后标准可能有助于确定可能经历治疗获益的患者亚组。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

PRO Hair Safe Study: The Patient's Perspective on the Effects of Scalp Cooling on Hair Preservation.

PRO Hair Safe Study: The Patient's Perspective on the Effects of Scalp Cooling on Hair Preservation.

PRO Hair Safe Study: The Patient's Perspective on the Effects of Scalp Cooling on Hair Preservation.

PRO Hair Safe Study: The Patient's Perspective on the Effects of Scalp Cooling on Hair Preservation.

Purpose: Alopecia has been reported a distressing side-effect of chemotherapy for breast cancer patients (BCP) that is highly relevant for quality of life during treatment. For the prevention of chemotherapy-induced alopecia, scalp cooling (SC) has been reported to be an effective and safe intervention. However, data on the patient's perspective on effectiveness and applicability of SC in a clinical routine setting are scarce. In this comparative study, we aimed at a longitudinal assessment of patient-reported outcome (PRO) data on the effect of SC on alopecia and its effect on symptoms and functional health when applied in clinical routine in BCP receiving taxane or anthracycline-based chemotherapy.

Patients and methods: Study participants were allocated either to the intervention group receiving SC or to the control group based on patient preference (non-randomized study). All patients completed PRO-measures on hair preservation (EORTC Item Library items on hair loss), symptom and functional health measures (EORTC QLQ-C30 and -BR23) and the Body Image Scale (BIS). Outcomes were assessed at chemotherapy start (baseline), mid-chemotherapy, last chemotherapy cycle, 3 months follow-up and 6-9 months follow-up.

Results: Overall, we included 113 patients: 75 patients underwent SC (mean age = 51.3 years, 52.7% premenopausal); 38 patients standard care (mean age = 55.6 years, 39.5% premenopausal). A total of 53 patients (70.7%) discontinued SC, with 39 patients (73.5%) stating alopecia as the primary reason. On average, BCP stayed on treatment with the cooling cap for 40.2% of the duration of their chemotherapy (SD 25.3%). In an intention-to-treat analysis, we found no difference between the SC group and the control group with regard to their patient-reported hair loss (p=0.831) across the observation period, overall QOL (p=0.627), emotional functioning (p=0.737), social functioning (p=0.635) and body image (p=0.463) did not differ between groups.

Conclusion: We found a high rate of SC-decliners and no beneficial effects of SC for patient-reported hair loss, symptoms and functional health. The efficacy and tolerability of SC applied in a clinical routine setting hence appeared to be limited. The further determination and up-front definition of criteria prognostic for effectiveness of SC may be helpful to identify patient subgroups that may experience a treatment benefit.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
CiteScore
4.10
自引率
0.00%
发文量
40
审稿时长
16 weeks
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信