Department of Health Services Research, Scientific Institute for Health Economics and Health Services Research (WIG2 GmbH), Leipzig, Germany.
Oncological Rehabilitation, Asklepios Tumorzentrum Hamburg, Hamburg, Germany.
Psychooncology. 2024 Oct;33(10):e70003. doi: 10.1002/pon.70003.
Breast cancer has a strong impact on the mental state of those affected. Cognitive behavioral therapy (CBT) is one effective approach to reduce disease burden. This randomized controlled pilot trial aimed to assess the effect of the digital CBT-based application Living Well on psychological outcomes in a German female breast cancer population.
Female breast cancer patients (n = 70) with ongoing or finished oncological treatment that is who were receiving or had received any type of oncological treatment were included in the study and randomized to an intervention group (IG, n = 32) receiving Living Well in addition to care as usual, and a control group (CG, n = 38) receiving care as usual only. Participants completed standardized questionnaires at baseline and after 2, 4, 8, and 12 weeks to assess anxiety and depression (HADS) as primary outcomes, distress (DT), health-related quality of life (HRQoL, AQoL-8D), and illness perception (B-IPQ) as secondary outcomes.
After 12 weeks, significant (p < 0.05) higher improvements in the IG could be observed in anxiety levels, HRQoL, and illness perception, when compared to the CG. Age and time since diagnosis were found to be relevant covariates for anxiety levels. In distress levels, the IG showed a clinically relevant and nearly significant reduction compared to the CG (p = 0.057). No effects could be observed in depression levels.
The results demonstrate the potential of Living Well to improve psychological outcomes of female breast cancer patients and encourage further studies evaluating the effectiveness of the digital application.
The trial has been registered in the German Clinical Trials Register (DRKS00029918).
乳腺癌对患者的精神状态有很大影响。认知行为疗法（CBT）是一种降低疾病负担的有效方法。本随机对照试验旨在评估基于数字 CBT 的应用程序“活得好”（Living Well）对德国女性乳腺癌患者心理结局的影响。
纳入正在接受或已接受任何类型的肿瘤治疗、且处于肿瘤治疗期间或已结束肿瘤治疗的女性乳腺癌患者（n=70），并将其随机分为干预组（IG，n=32），在接受常规护理的基础上增加使用“活得好”；对照组（CG，n=38）仅接受常规护理。参与者在基线时和治疗后第 2、4、8 和 12 周时完成标准化问卷，以评估焦虑和抑郁（HADS）作为主要结局，苦恼（DT）、健康相关生活质量（AQoL-8D）和疾病认知（B-IPQ）作为次要结局。
治疗 12 周后，与 CG 相比，IG 的焦虑水平、HRQoL 和疾病认知显著（p<0.05）改善。年龄和诊断后时间被发现是焦虑水平的相关协变量。在苦恼水平方面，IG 与 CG 相比表现出临床相关且接近显著的降低（p=0.057）。抑郁水平无显著变化。
结果表明“活得好”有改善女性乳腺癌患者心理结局的潜力，并鼓励进一步研究评估该数字应用程序的有效性。
该试验已在德国临床试验注册中心（DRKS00029918）注册。
