研究动态
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一项全面的为期6个月的前列腺癌患者授权计划在进行根治性前列腺癌治疗的男性中降低了心理痛苦的临床试验。

A Comprehensive 6-mo Prostate Cancer Patient Empowerment Program Decreases Psychological Distress Among Men Undergoing Curative Prostate Cancer Treatment: A Randomized Clinical Trial.

发表日期:2023 Feb 21
作者: Gabriela Ilie, Ricardo Rendon, Ross Mason, Cody MacDonald, Mike J Kucharczyk, Nikhilesh Patil, David Bowes, Greg Bailly, David Bell, Joseph Lawen, Michael Ha, Derek Wilke, Peter Massaro, Jeffery Zahavich, George Kephart, Robert David Harold Rutledge
来源: EUROPEAN UROLOGY

摘要:

虽然新被诊断的前列腺癌患者的生存率非常高,但他们中的大多数可能会遭受与治疗有关的重大副作用,抑郁或焦虑,影响他们的生活质量。本研究的目的是检查为期6个月的在线家庭自助物理、心理和社会支持干预——前列腺癌患者自主计划(PC-PEP)对于正在接受治疗的男性预防心理困扰的影响。在一项交叉随机对照试验中,选取128名年龄在50岁至82岁之间的男性接受前列腺癌根治性手术或放疗(±激素治疗),其中66人接受了6个月的PC-PEP干预措施,62人随机分配到等待名单对照组,并接受6个月的标准治疗,随后再进行PC-PEP直到年底。 PC-PEP干预措施包括每天通过视频指导提供教育、病人激活和激励,指导健康生活方式,包括身体和心理健康、膳食建议、社会支持、身体和盆底训练、使用生物反馈设备减压、社交和亲密关系以及社会支持。主要结果是基线的非特异性心理困扰(临床截止≥20),并在6个月和12个月使用Kessler心理困扰量表(K10)进行测量。在6个月时,等待名单对照组的患者出现了3.59(95%置信区间:1.12-11.51)倍的非特异性心理困扰和需要心理治疗的高于接受PC-PEP干预措施的人群。在12个月时,接受干预的待名单对照组的非特异性心理困扰高于早期组。与标准治疗或晚期(6个月后)的干预相比,早期进行PC-PEP干预措施显著预防了正在接受前列腺癌根治性治疗的男性的心理困扰负担。在这篇报告中,我们研究了一种由患者参与开发的计划(前列腺癌患者自主计划:PC-PEP),旨在缓解等待根治性治疗前列腺癌患者的心理困扰。 PC-PEP计划持续6个月,通过每日有氧和力量训练、凯格尔锻炼(盆底训练有助于改善尿液和性功能)、膳食改变、生物反馈设备的应用减压以及社会和情感支持,规定、描述和演示。所有PC-PEP计划中的患者都被邀请参加由该计划领导召开的每月视频会议,这些领导在6个月的每日视频中出现,规定了患者被要求观看和遵循的活动。领导者是前列腺癌肿瘤学家和前列腺癌生活质量研究专家。在这项研究中,一半的患者在前6个月每天接受PC-PEP,然后在年底进行再评估。另一半患者接受标准治疗6个月,然后接受干预措施,持续到年底。该研究结果显示,在6个月时,此种干预措施有效地减轻了前列腺癌诊断和治疗相关的心理困扰,与标准治疗相比。当早期接受干预时,心理压力显著降低,而晚期(在计划治疗后6个月)接受的干预略有降低。我们得出结论,从患者开始参与的多方面患者教育和激活编程对于诊断前列腺癌的患者的护理至关重要,并应在标准护理中实施。尽管前列腺癌治疗非常成功,但大多数治疗的副作用显著影响了患者的生活质量。在这里,我们介绍了PC-PEP,一种患者教育和激活计划,具有成本效益,患者高度执行,并成功降低了前列腺癌积极治疗相关副作用对其心理状态的影响。要了解更多有关该项目的信息,请访问www.pcpep.org。该计划现在正在加拿大和国际(新西兰)进行第四阶段实施试验,并正在扩大和测试用于其他类型的癌症。 版权所有©2023 The Author(s),Elsevier B.V.发表。保留所有权利。
Although survival rates for newly diagnosed prostate cancer patients are very high, most of them will likely suffer significant treatment-related side effects, depression, or anxiety, affecting their quality of life.The aim of this study was to examine the effects of a 6-mo online home-based physical, mental, and social support intervention, the Prostate Cancer Patient Empowerment Program (PC-PEP), on preventing psychological distress among men undergoing curative prostate cancer treatment.In a crossover randomized clinical trial of 128 men aged 50-82 yr scheduled for curative prostate cancer surgery or radiotherapy (± hormone treatment), 66 received the 6-mo PC-PEP intervention and 62 were randomized to a waitlist-control arm and received the standard of care for 6 mo, and then PC-PEP to the end of the year. The PC-PEP intervention consisted of daily e-mails with video instructions providing education, patient activation, and empowerment on healthy living including physical and mental health, dietary recommendations, social support, physical and pelvic floor fitness, stress reduction using a biofeedback device, social connection and intimacy, and social support.The primary outcome was nonspecific psychological distress (clinical cutoff ≥20) measured at baseline, and at 6 and 12 mo using the Kessler Psychological Distress Scale (K10).At 6 mo, patients in the waitlist-control group had 3.59 (95% confidence interval: 1.12-11.51) times higher odds for nonspecific psychological distress and need for psychological treatment than men who received the PC-PEP intervention. At 12 mo, the wait-list control group that received the intervention at 6 mo had higher psychological distress than the early group.PC-PEP delivered early following diagnosis significantly prevented the burden of psychological distress in men undergoing curative prostate cancer treatment compared with standard of care, or late (6 mo later) intervention.In this report, we looked at the effectiveness of a program (Prostate Cancer Patient Empowerment Program: PC-PEP) developed with patients' engagement on the mental distress of patients awaiting curative treatment for their prostate cancer. The PC-PEP program lasted for 6 mo, and it prescribed, described, and demonstrated daily aerobic and strength training, kegels (pelvic floor training to help with urinary and sexual function), dietary changes that have been shown to be helpful in the prevention of prostate cancer and prostate cancer progression, stress reduction using a biofeedback device, as well as social and emotional support. All patients in the PC-PEP program were invited to a monthly video conference with the leads of the program who appeared in the 6 mo of daily videos prescribing the activities the patients were asked to watch and follow. The leads were a prostate cancer oncologist and a scientist in prostate cancer quality of life research. Half of the patients in this study received PC-PEP daily for the first 6 mo and were re-assessed at the end of the year. The other half received standard of care for 6 month and then received the intervention to the end of the year. The results of the study show that, at 6 mo, this intervention was effective at reducing the mental distress that accompanies a prostate cancer diagnosis and treatment compared with the standard of care. Mental distress was significantly reduced when the intervention was received early, compared with that received late (6 mo after scheduled curative treatment). We conclude that multi-faceted patient education and empowerment programming of this kind that is developed with patient engagement from the start is crucial to the care of patients diagnosed with prostate cancer and should be implemented in the standard of care. While treatment for prostate cancer is highly successful, side effects that accompany most treatments significantly affect the quality of life of patients. Here, we describe PC-PEP, a patient education and activation program that is cost effective, highly enforced by patients, and successful at reducing the impact of prostate cancer active treatment-related side effects on their psychological state. To learn more about this project, please visit www.pcpep.org. The program is now being tested in a phase 4 implementation trial throughout Canada and internationally (New Zealand), and is being expanded and tested for other types of cancer.Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.