{"title":"心律疗法与慢节奏体育锻炼治疗转移性乳腺癌患者疲劳的随机对照试验。","authors":"Eliane Timm, Ilana Berlowitz, Ursula Wolf","doi":"10.1093/oncolo/oyaf343","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Cancer-related fatigue is among the most taxing symptoms of breast cancer patients, but there is currently no established treatment standard. This study assessed the effect of eurythmy therapy (ERYT), a tailored mindful movement therapy, compared to slow-paced physical exercises (CoordiFit) on fatigue in metastatic breast cancer patients.</p><p><strong>Methods: </strong>We used a randomized controlled, open-label, multi-center, two-arm design. Ten certified oncology centers across Switzerland participated in the trial. Women with metastatic breast cancer who agreed to participate in the study were randomly allocated to one of the two study arms in a 1:1 ratio. The intervention sessions in both groups followed the same schedule in terms of frequency and duration over a period of 20 weeks. Outcomes were assessed using standard clinical assessment scales at baseline, weeks 8, 14, and 20, as well as at 6- and 12-months follow-up. The primary endpoint was the change in cancer-related fatigue (baseline to end of intervention), whereas secondary endpoints included quality of life, pain, sleep quality, depression, anxiety, distress, and arm mobility. Data was analyzed using two-way mixed ANOVA.</p><p><strong>Results: </strong>The study was terminated before its completion due to insufficient enrollment. Prior to its closure, a total of 19 patients (median age: 59.5, range 51-82) agreed to participate in the study, of whom 10 completed the full intervention (n = 5 per group). Although the small sample size limits the possibility of statistical inference, tentative analyses pointed to significant improvements in fatigue in response to both experimental and control interventions (F(1,8)=14.176, p = 0.006), with no difference between groups. Among secondary endpoints we found a main group effect in quality of life, which was significantly higher in the ERYT group (F(1,8)=7.179, p=.028), as well as an interaction effect in pain interference, the latter significantly improving in the ERYT group but not the CoordiFit group (F(1,8)=7.977, p=.022).</p><p><strong>Conclusion: </strong>While the results show a promising decrease in cancer-related fatigue in response to ERYT, this held true also for the movement-based control intervention, suggesting ERYT to be valuable, but not superior to other movement-based approaches for cancer-related fatigue. However, the small sample size limits the conclusions that can be drawn.</p><p><strong>Clinicaltrials.gov identifier: </strong>#NCT04024267.</p>","PeriodicalId":54686,"journal":{"name":"Oncologist","volume":" ","pages":""},"PeriodicalIF":4.2000,"publicationDate":"2025-10-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Randomized controlled trial on eurythmy therapy versus slow-paced physical exercises for the treatment of fatigue in metastatic breast cancer patients.\",\"authors\":\"Eliane Timm, Ilana Berlowitz, Ursula Wolf\",\"doi\":\"10.1093/oncolo/oyaf343\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Cancer-related fatigue is among the most taxing symptoms of breast cancer patients, but there is currently no established treatment standard. This study assessed the effect of eurythmy therapy (ERYT), a tailored mindful movement therapy, compared to slow-paced physical exercises (CoordiFit) on fatigue in metastatic breast cancer patients.</p><p><strong>Methods: </strong>We used a randomized controlled, open-label, multi-center, two-arm design. Ten certified oncology centers across Switzerland participated in the trial. Women with metastatic breast cancer who agreed to participate in the study were randomly allocated to one of the two study arms in a 1:1 ratio. The intervention sessions in both groups followed the same schedule in terms of frequency and duration over a period of 20 weeks. Outcomes were assessed using standard clinical assessment scales at baseline, weeks 8, 14, and 20, as well as at 6- and 12-months follow-up. The primary endpoint was the change in cancer-related fatigue (baseline to end of intervention), whereas secondary endpoints included quality of life, pain, sleep quality, depression, anxiety, distress, and arm mobility. Data was analyzed using two-way mixed ANOVA.</p><p><strong>Results: </strong>The study was terminated before its completion due to insufficient enrollment. Prior to its closure, a total of 19 patients (median age: 59.5, range 51-82) agreed to participate in the study, of whom 10 completed the full intervention (n = 5 per group). Although the small sample size limits the possibility of statistical inference, tentative analyses pointed to significant improvements in fatigue in response to both experimental and control interventions (F(1,8)=14.176, p = 0.006), with no difference between groups. Among secondary endpoints we found a main group effect in quality of life, which was significantly higher in the ERYT group (F(1,8)=7.179, p=.028), as well as an interaction effect in pain interference, the latter significantly improving in the ERYT group but not the CoordiFit group (F(1,8)=7.977, p=.022).</p><p><strong>Conclusion: </strong>While the results show a promising decrease in cancer-related fatigue in response to ERYT, this held true also for the movement-based control intervention, suggesting ERYT to be valuable, but not superior to other movement-based approaches for cancer-related fatigue. 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引用次数: 0
摘要
背景:癌症相关性疲劳是乳腺癌患者最令人头痛的症状之一,但目前尚无确定的治疗标准。这项研究评估了心律疗法(ERYT),一种量身定制的正念运动疗法,与慢节奏体育锻炼(协调健身)对转移性乳腺癌患者疲劳的影响。方法:采用随机对照、开放标签、多中心、双臂设计。瑞士有10家经过认证的肿瘤中心参与了这项试验。同意参与研究的转移性乳腺癌患者被随机分配到两个研究组中,比例为1:1。在20周的时间里,两组的干预会议在频率和持续时间方面遵循相同的时间表。在基线、第8周、第14周和第20周以及6个月和12个月随访时,使用标准临床评估量表评估结果。主要终点是癌症相关疲劳的变化(基线至干预结束),而次要终点包括生活质量、疼痛、睡眠质量、抑郁、焦虑、痛苦和手臂活动能力。数据分析采用双向混合方差分析。结果:由于入组人数不足,研究在完成前终止。在结束之前,共有19名患者(年龄中位数:59.5,范围51-82)同意参加研究,其中10名患者完成了完整的干预(每组n = 5)。虽然小样本量限制了统计推断的可能性,但初步分析表明,实验组和对照组干预措施均显著改善了疲劳症状(F(1,8)=14.176, p = 0.006),组间无差异。在次要终点中,我们发现主要组效应在生活质量方面,在ERYT组显著更高(F(1,8)=7.179, p= 0.028),以及在疼痛干扰方面的交互效应,后者在ERYT组显著改善,而在codifit组无显著改善(F(1,8)=7.977, p= 0.022)。结论:虽然结果显示对ERYT有希望减少癌症相关疲劳,但这也适用于基于运动的控制干预,这表明ERYT是有价值的,但并不优于其他基于运动的癌症相关疲劳方法。然而,样本量小限制了可以得出的结论。
Randomized controlled trial on eurythmy therapy versus slow-paced physical exercises for the treatment of fatigue in metastatic breast cancer patients.
Background: Cancer-related fatigue is among the most taxing symptoms of breast cancer patients, but there is currently no established treatment standard. This study assessed the effect of eurythmy therapy (ERYT), a tailored mindful movement therapy, compared to slow-paced physical exercises (CoordiFit) on fatigue in metastatic breast cancer patients.
Methods: We used a randomized controlled, open-label, multi-center, two-arm design. Ten certified oncology centers across Switzerland participated in the trial. Women with metastatic breast cancer who agreed to participate in the study were randomly allocated to one of the two study arms in a 1:1 ratio. The intervention sessions in both groups followed the same schedule in terms of frequency and duration over a period of 20 weeks. Outcomes were assessed using standard clinical assessment scales at baseline, weeks 8, 14, and 20, as well as at 6- and 12-months follow-up. The primary endpoint was the change in cancer-related fatigue (baseline to end of intervention), whereas secondary endpoints included quality of life, pain, sleep quality, depression, anxiety, distress, and arm mobility. Data was analyzed using two-way mixed ANOVA.
Results: The study was terminated before its completion due to insufficient enrollment. Prior to its closure, a total of 19 patients (median age: 59.5, range 51-82) agreed to participate in the study, of whom 10 completed the full intervention (n = 5 per group). Although the small sample size limits the possibility of statistical inference, tentative analyses pointed to significant improvements in fatigue in response to both experimental and control interventions (F(1,8)=14.176, p = 0.006), with no difference between groups. Among secondary endpoints we found a main group effect in quality of life, which was significantly higher in the ERYT group (F(1,8)=7.179, p=.028), as well as an interaction effect in pain interference, the latter significantly improving in the ERYT group but not the CoordiFit group (F(1,8)=7.977, p=.022).
Conclusion: While the results show a promising decrease in cancer-related fatigue in response to ERYT, this held true also for the movement-based control intervention, suggesting ERYT to be valuable, but not superior to other movement-based approaches for cancer-related fatigue. However, the small sample size limits the conclusions that can be drawn.
期刊介绍:
The Oncologist® is dedicated to translating the latest research developments into the best multidimensional care for cancer patients. Thus, The Oncologist is committed to helping physicians excel in this ever-expanding environment through the publication of timely reviews, original studies, and commentaries on important developments. We believe that the practice of oncology requires both an understanding of a range of disciplines encompassing basic science related to cancer, translational research, and clinical practice, but also the socioeconomic and psychosocial factors that determine access to care and quality of life and function following cancer treatment.