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基于移动的护士主导的健康辅导方案对代谢综合征高危前列腺癌患者的有效性:随机候补对照试验。

Effectiveness of a Nurse-Led Mobile-Based Health Coaching Program for Patients With Prostate Cancer at High Risk of Metabolic Syndrome: Randomized Waitlist Controlled Trial.

机构信息

College of Nursing and Brain Korea 21 FOUR Project, Yonsei University, Seoul, Republic of Korea.

College of Nursing, Kyungbok University, Namyangju, Republic of Korea.

出版信息

JMIR Mhealth Uhealth. 2024 Feb 1;12:e47102. doi: 10.2196/47102.

Abstract

BACKGROUND

Androgen deprivation therapy (ADT), a standard treatment for prostate cancer (PC), causes many physical side effects. In particular, it causes metabolic changes such as fasting glucose abnormalities or accumulation of body fat, and its continuation can lead to metabolic syndrome (MetS), which is closely related to diabetes and cardiovascular disease. Therefore, it is important to maintain and practice a healthy lifestyle in patients with PC.

OBJECTIVE

This study aims to evaluate the effectiveness of a nurse-led mobile-based program that aims to promote a healthy lifestyle in patients with PC undergoing ADT with MetS risk factors.

METHODS

This was a single-blind, randomized, waitlist control interventional study. A total of 48 patients were randomly assigned to the experimental and waitlist control groups at the urology cancer clinic of a tertiary general hospital in South Korea. The inclusion criteria were patients who had undergone ADT for >6 months, had at least 1 of the 5 MetS components in the abnormal range, and could access a mobile-based education program. The experimental group attended a 4-week mobile-based program on exercise and diet that included counseling and encouragement to maintain a healthy lifestyle, whereas the control group was placed on a waitlist and received usual care during the follow-up period, followed by the intervention. The primary outcome was a change in the lifestyle score. The secondary outcomes were changes in 5 MetS components, body composition, and health-related quality of life. The outcomes were measured at 6 weeks and 12 weeks after the initiation of the intervention. Each participant was assigned to each group in a sequential order of enrollment in a 4×4 permuted block design randomization table generated in the SAS (SAS Institute) statistical program. A linear mixed model was used for statistical analysis.

RESULTS

A total of 24 participants were randomly assigned to each group; however, 2 participants in the experimental group dropped out for personal reasons before starting the intervention. Finally, 46 participants were included in the intention-to-treat analysis. The experimental group showed more positive changes in the healthy lifestyle score (β=29.23; P≤.001), level of each MetS component (fasting blood sugar: β=-12.0; P=.05 and abdominal circumference: β=-2.49; P=.049), body composition (body weight: β=-1.52; P<.001 and BMI: β=-0.55; P<.001), and the urinary irritative and obstructive domain of health-related quality of life (β=14.63; P<.001) over time than the waitlist control group.

CONCLUSIONS

Lifestyle changes through nurse-led education can improve level of each MetS components, body composition, and ADT side effects. Nurses can induce positive changes in patients' lifestyles and improve the self-management of patients starting ADT through this program.

TRIAL REGISTRATION

Clinical Research Information Service KCT0006560; http://tinyurl.com/yhvj4vwh.

摘要

背景

去势治疗(ADT)是前列腺癌(PC)的标准治疗方法,会引起许多身体副作用。特别是,它会引起代谢变化,如空腹血糖异常或体脂堆积,其持续存在会导致代谢综合征(MetS),这与糖尿病和心血管疾病密切相关。因此,对于接受 ADT 治疗且存在 MetS 风险因素的 PC 患者,保持和实践健康的生活方式非常重要。

目的

本研究旨在评估一种护士主导的基于移动的方案对患有 PC 且存在 MetS 风险因素的患者促进健康生活方式的有效性。

方法

这是一项单盲、随机、等待名单对照干预研究。共有 48 名患者在韩国一家三级综合医院的泌尿科癌症诊所随机分为实验组和等待名单对照组。纳入标准为接受 ADT 治疗>6 个月、至少有 5 个 MetS 成分异常和可以使用移动教育计划的患者。实验组参加了为期 4 周的关于运动和饮食的基于移动的方案,包括咨询和鼓励维持健康的生活方式,而对照组在随访期间处于等待名单状态,并接受常规护理,随后进行干预。主要结局是生活方式评分的变化。次要结局是 5 个 MetS 成分、身体成分和健康相关生活质量的变化。在干预开始后的 6 周和 12 周测量这些结果。每位参与者在 SAS(SAS Institute)统计程序中生成的 4×4 置换块设计随机化表中按入组的顺序被分配到每个组。使用线性混合模型进行统计分析。

结果

共有 24 名参与者被随机分配到每个组,但实验组有 2 名参与者因个人原因在开始干预前退出。最后,共有 46 名参与者进行了意向性治疗分析。实验组在健康生活方式评分(β=29.23;P≤.001)、每个 MetS 成分(空腹血糖:β=-12.0;P=.05 和腰围:β=-2.49;P=.049)、身体成分(体重:β=-1.52;P<.001 和 BMI:β=-0.55;P<.001)和健康相关生活质量的尿激惹和阻塞领域(β=14.63;P<.001)方面显示出更积极的变化随着时间的推移比等待名单对照组。

结论

通过护士主导的教育进行生活方式改变可以改善每个 MetS 成分、身体成分和 ADT 副作用的水平。护士可以通过该方案诱导患者生活方式的积极改变,并提高开始接受 ADT 治疗的患者的自我管理能力。

试验注册

临床研究信息服务 KCT0006560;http://tinyurl.com/yhvj4vwh。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fa23/10870207/68a853a7ad29/mhealth_v12i1e47102_fig1.jpg

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