量化自我监测干预对癌症伴周围神经病变患者有效性的随机临床试验：一项定量研究。
Randomized clinical trial quantifying the effectiveness of a self-monitoring intervention in cancer patients with peripheral neuropathy: A quantitative study.
作者信息
Kanda Kiyoko, Ishida Kazuko, Kyota Ayumi, Ishihara Chiaki, Fujimoto Keiko, Hosokawa Mai, Mochizuki Ruka
机构信息
Nursing Department, Takasaki University of Health and Welfare, Takasaki-shi, Japan.
Niigata College of Nursing, Joetsu-shi, Japan.
出版信息
Asia Pac J Oncol Nurs. 2023 Feb 4;10(4):100198. doi: 10.1016/j.apjon.2023.100198. eCollection 2023 Apr.
OBJECTIVE
The aim of this study was to quantitatively evaluate the efficacy of a self-monitoring intervention for the management of persistent chemotherapy-induced peripheral neuropathy (CIPN).
METHODS
A randomized controlled clinical trial was conducted on 65 outpatients receiving taxane or platinum-based anticancer drugs. Participants were assigned to the control group (CG; = 32) or the self-monitoring group (SMG; = 33) and followed for 6 weeks. Non-interveners were blinded. Participants in the intervention group self-monitored and recorded. The researchers provided feedback on the recorded symptoms and coping strategies once every 3 weeks. The efficacy of the 6-week self-monitoring intervention was assessed, using various measures, at baseline (T0), 3 weeks (T1), and 6 weeks (T2). Scores of CIPN, Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity, Distress and Impact Thermometer, Self-Efficacy Scale for Advanced Cancer, and Functional Assessment of Cancer Therapy-General of both groups were compared. Safety behavior in daily life was also compared. The study was conducted from August 9, 2017 to March 30, 2020 in outpatient clinics at three hospitals. Analysis was conducted using the -test, Mann-Whitney test, χ test, and two-way repeated-measures analysis of variance (two-way RMANOVA).
RESULTS
No significant differences were noted between the two groups in the CIPN score, the Distress and Impact Thermometer score, and in safety behavior in daily life. The mean Self-Efficacy Scale for Advanced Cancer score at T1 differed between the two groups (CG mean ± SD: 358.44 ± 109.90; SMG mean ± SD: 421.21 ± 85.54), which was significantly higher in the SMG ( = 0.012). Two-way RMANOVA revealed an interaction between the CG and SMG ( = 5.689, = 0.004). Quality of life scores were higher in the SMG than in the CG at T0, T1, and T2. Two-way RMANOVA analysis showed an effect of the intervention ( = 7.914, = 0.007).
CONCLUSIONS
The self-monitoring intervention maintained the participants' quality of life. This finding suggests its effectiveness in patients with peripheral neuropathy.
目的
本研究旨在定量评估自我监测干预对持续性化疗引起的周围神经病变（CIPN）管理的疗效。
方法
对65名接受紫杉烷或铂类抗癌药物治疗的门诊患者进行了一项随机对照临床试验。参与者被分配到对照组（CG；n = 32）或自我监测组（SMG；n = 33），并随访6周。非干预者为盲法。干预组的参与者进行自我监测和记录。研究人员每3周就记录的症状和应对策略提供一次反馈。在基线（T0）、3周（T1）和6周（T2）时，使用各种测量方法评估为期6周的自我监测干预的疗效。比较两组的CIPN评分、癌症治疗功能评估/妇科肿瘤学组神经毒性评分、痛苦与影响温度计评分、晚期癌症自我效能量表评分以及癌症治疗功能评估-通用评分。还比较了日常生活中的安全行为。该研究于2017年8月9日至2020年3月30日在三家医院的门诊进行。使用t检验、曼-惠特尼U检验、χ²检验和双向重复测量方差分析（双向RMANOVA）进行分析。
结果
两组在CIPN评分、痛苦与影响温度计评分以及日常生活安全行为方面均未观察到显著差异。两组在T1时晚期癌症自我效能量表的平均评分存在差异（CG组平均值±标准差：358.44±109.90；SMG组平均值±标准差：421.21±85.54），SMG组显著更高（P = 0.012）。双向RMANOVA显示CG组和SMG组之间存在交互作用（F = 5.689，P = 0.004）。在T0、T1和T2时，SMG组的生活质量评分高于CG组。双向RMANOVA分析显示干预有效果（F = 7.914，P = 0.007）。
结论
自我监测干预维持了参与者的生活质量。这一发现表明其对周围神经病变患者有效。
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