Optimune 试验结果：一项评估新型互联网干预措施对乳腺癌幸存者影响的随机对照试验。
Results of the Optimune trial: A randomized controlled trial evaluating a novel Internet intervention for breast cancer survivors.
机构信息
Research Department, Gaia Group, Hamburg, Germany.
Department of Medical Psychology and Medical Sociology University Hospital of Leipzig, Leipzig, Germany.
出版信息
PLoS One. 2021 May 7;16(5):e0251276. doi: 10.1371/journal.pone.0251276. eCollection 2021.
INTRODUCTION
After the acute treatment phase, breast cancer patients often experience low quality of life and impaired mental health, which could potentially be improved by offering cognitive behavioural therapy (CBT) and addressing exercise and dietary habits. However, CBT and other behavioural interventions are rarely available beyond the acute treatment phase. Internet-based interventions could bridge such treatment gaps, given their flexibility and scalability. In this randomized controlled trial (RCT), we investigated the effects of such an intervention ("Optimune") over three months.
METHODS
This RCT included 363 female breast cancer survivors (age range = 30-70), recruited from the community, who had completed the active treatment phase. Inclusion criteria were: breast cancer diagnosis less than 5 years ago and acute treatment completion at least 1 month ago. Participants were randomly assigned to (1) an intervention group (n = 181), in which they received care as usual (CAU) plus 12-month access to Optimune immediately after randomization, or (2) a control group (n = 182), in which they received CAU and Optimune after a delay of 3 months. Primary endpoints were quality of life (QoL), physical activity, and dietary habits at three months. We hypothesized that intervention group participants would report better QoL, more physical activity, and improved dietary habits after 3 months.
RESULTS
Intention-to-treat (ITT) analyses revealed significant effects on QoL (d = 0.27, 95% CI: 0.07-0.48) and dietary habits (d = 0.36, 95% CI: 0.15-0.56), but the effect on physical exercise was not significant (d = 0.30; 95% CI: 0.10-0.51).
DISCUSSION
These findings suggest the effectiveness of Optimune, a new CBT-based Internet intervention for breast cancer survivors, in facilitating improvements in quality of life and dietary habits. Efforts to disseminate this intervention more broadly may be warranted.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT03643640. Registered August 23rd 2018, https://clinicaltrials.gov/ct2/show/NCT03643640.
简介
在急性治疗阶段后，乳腺癌患者经常经历生活质量下降和心理健康受损，通过提供认知行为疗法（CBT）并解决运动和饮食习惯，这一情况可能得到改善。然而，CBT 和其他行为干预措施在急性治疗阶段后很少提供。鉴于其灵活性和可扩展性，基于互联网的干预措施可以弥补这些治疗差距。在这项随机对照试验（RCT）中，我们在三个月的时间里研究了这种干预措施（"Optimune"）的效果。
方法
这项 RCT 纳入了 363 名来自社区的女性乳腺癌幸存者（年龄范围为 30-70 岁），她们已经完成了积极的治疗阶段。纳入标准为：乳腺癌诊断时间不足 5 年，且急性治疗至少在 1 个月前完成。参与者被随机分配到（1）干预组（n = 181），其中他们在随机分组后立即获得常规护理（CAU）加 12 个月的 Optimune 访问权限，或（2）对照组（n = 182），其中他们在 3 个月后获得 CAU 和 Optimune。主要终点是三个月时的生活质量（QoL）、身体活动和饮食习惯。我们假设干预组参与者在 3 个月后会报告更好的 QoL、更多的身体活动和改善的饮食习惯。
结果
意向治疗（ITT）分析显示，在 QoL（d = 0.27，95%CI：0.07-0.48）和饮食习惯（d = 0.36，95%CI：0.15-0.56）方面有显著效果，但对身体活动的效果不显著（d = 0.30；95%CI：0.10-0.51）。
讨论
这些发现表明，Optimune，一种新的基于 CBT 的乳腺癌幸存者互联网干预措施，在促进生活质量和饮食习惯的改善方面是有效的。可能需要努力更广泛地传播这种干预措施。
试验注册
ClinicalTrials.gov，NCT03643640。于 2018 年 8 月 23 日注册，https://clinicaltrials.gov/ct2/show/NCT03643640。
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