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一项关于患者报告结局的初步研究,评估接受高剂量率近距离放疗联合低分割放疗或单纯低分割放疗治疗局限性前列腺癌的男性患者的治疗相关症状和生活质量。

A pilot study of patient reported outcomes evaluating treatment related symptoms and quality of life for men receiving high dose rate brachytherapy combined with hypo-fractionated radiotherapy or hypo-fractionated radiotherapy alone for the treatment of localised prostate cancer.

作者信息

Crowther Karen, Cole Aidan, Shiels Pat, Jain Suneil, Shepherd Paul, Mitchell Darren

机构信息

Radiotherapy Department, Cancer Centre, Belfast City Hospital, Belfast Health and Social Care Trust, Lisburn Road, Belfast, United Kingdom.

Centre for Cancer Research and Cell Biology, Queen's University of Belfast, Lisburn Road, Belfast, United Kingdom.

出版信息

Tech Innov Patient Support Radiat Oncol. 2019 Feb 22;9:18-25. doi: 10.1016/j.tipsro.2019.01.003. eCollection 2019 Mar.

Abstract

Patient Reported Outcome Measures (PROMS) are useful metrics in evidence-based clinical care and translational research. Recording treatment-related symptoms and Quality of Life (QoL) can provide information in counselling patients to aid decision-making. This prospective study tested the feasibility of radiographer-led collection of multiple validated PROMS from Prostate Cancer (PCa) patients comparing High Dose Rate Brachytherapy combined with hypo-fractionated external beam radiotherapy (hEBRT) and hEBRT alone. From June to August 2017, 20 men with localised PCa (T1-T3aN0M0) consented to participate in the study. Ten patients received combination treatment (37.5 Gray/15 fractions followed by a 15 Gray implant), and ten patients received monotherapy (60 Gray/20 fractions). PROMS were collected at four time-points (1) at baseline, (2) final fraction of hEBRT, (3) 8 weeks after commencing radiotherapy and (4) 12 weeks after commencing radiotherapy. The PROMS used were EPIC-26, IPSS, IIEFF-5 and SF-12. The difference between the two groups were tested using Mann-Whitney U test and Wilcoxon Signed-Rank Test. All participants completed all PROMS (100% response-rate). The Monotherapy group reported a higher incidence of bowel symptoms compared to the combination group and at Week 12, EPIC-26 bowel summary score demonstrated a statistically significant difference (p = 0.005). The prevalence of erectile dysfunction increased within both groups. Maintenance of QoL was reported throughout treatment. This small study demonstrated feasibility of radiographer-led PROMS collection by 100% completion rate. Streamlining of these tools into integrated technology applications and real time PROMS measurement has the ability to benefit patients and guide clinicians in adapting therapies based on individual need.

摘要

患者报告结局指标(PROMS)是循证临床护理和转化研究中的有用指标。记录与治疗相关的症状和生活质量(QoL)可为患者咨询提供信息,以辅助决策。这项前瞻性研究测试了由放射技师主导从前列腺癌(PCa)患者中收集多个经过验证的PROMS的可行性,比较了高剂量率近距离放疗联合低分割外照射放疗(hEBRT)与单纯hEBRT的效果。2017年6月至8月,20名局限性PCa(T1 - T3aN0M0)男性同意参与该研究。10名患者接受联合治疗(37.5格雷/15次分割,随后植入15格雷),10名患者接受单一疗法(60格雷/20次分割)。在四个时间点收集PROMS:(1)基线时,(2)hEBRT的最后一次分割时,(3)开始放疗后8周,以及(4)开始放疗后12周。使用的PROMS包括EPIC - 26、IPSS、IIEFF - 5和SF - 12。两组之间的差异采用曼 - 惠特尼U检验和威尔科克森符号秩检验。所有参与者均完成了所有PROMS(应答率为100%)。与联合治疗组相比,单一疗法组报告的肠道症状发生率更高,在第12周时,EPIC - 26肠道总结评分显示出统计学上的显著差异(p = 0.005)。两组勃起功能障碍的患病率均有所增加。整个治疗过程中均报告了生活质量的维持情况。这项小型研究以100%的完成率证明了由放射技师主导收集PROMS的可行性。将这些工具简化为集成技术应用和实时PROMS测量,有能力使患者受益,并指导临床医生根据个体需求调整治疗方案。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1b39/7033792/f1c0224e7a17/gr1.jpg

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