Blue Note Therapeutics, San Francisco, CA.
King's College London, London, United Kingdom.
JCO Oncol Pract. 2023 Dec;19(12):1179-1189. doi: 10.1200/OP.23.00210. Epub 2023 Oct 20.
Patients with cancer often experience elevated levels of distress. This double-blind, randomized controlled trial compared the impact of an app-based version of cognitive behavioral stress management (CBSM) versus a health education sham app on anxiety and depression symptoms.
Patients with nonmetastatic (stage I-III) cancer who were receiving or recently completed (≤6 months) systemic treatment were recruited nationwide. The primary outcome of change in anxiety symptoms (PROMIS-Anxiety) over 12 weeks and the top secondary outcome of change in depression symptoms (PROMIS-Depression) over 12 weeks were analyzed using mixed-effects modeling with repeated measures (weeks 0, 4, 8, 12). Patient global impressions of change in anxiety and depression were reported at weeks 4, 8, and 12. In addition, self-reported adverse events were collected throughout the study and adjudicated by the site principal investigator.
Four hundred forty-nine patients were enrolled in the trial (age M [standard deviation] = 52.44 [11.46]; 81% female; 76% White; 53% breast cancer). Patients randomly assigned to digitized CBSM showed significantly greater reductions in anxiety ( = -0.03; = .019) and depression ( = -0.02; = .042) symptoms over 12 weeks. Patients who received digitized CBSM were also significantly more likely to perceive much or very much improvement ( no/minimal change or much/very much worse) in their symptoms of anxiety (χ = 31.76; < .001) and depression (χ = 19.70; < .001) compared with the control.
The use of digitized CBSM led to significant improvements in anxiety and depression outcomes compared with the sham app.
癌症患者常经历焦虑水平升高。本双盲、随机对照试验比较了基于应用程序的认知行为应激管理（CBSM）与健康教育培训应用程序对焦虑和抑郁症状的影响。
在全国范围内招募接受或最近完成（≤6 个月）全身治疗的非转移性（I-III 期）癌症患者。使用混合效应模型重复测量（第 0、4、8、12 周）分析 12 周时焦虑症状（PROMIS-Anxiety）变化的主要结局和 12 周时抑郁症状（PROMIS-Depression）变化的首要次要结局。第 4、8 和 12 周时报告患者焦虑和抑郁变化的整体印象。此外，在整个研究过程中收集了自我报告的不良事件，并由现场主要研究者进行裁决。
该试验共纳入 449 例患者（年龄 M [标准差] = 52.44 [11.46]；81%女性；76%白人；53%乳腺癌）。随机分配到数字化 CBSM 的患者在 12 周内焦虑（ = -0.03； =.019）和抑郁（ = -0.02； =.042）症状明显减轻。接受数字化 CBSM 的患者也更有可能认为他们的焦虑（χ = 31.76； <.001）和抑郁（χ = 19.70； <.001）症状有很大或非常大的改善（无/最小改善或很大/非常差），与对照组相比。
与 sham 应用程序相比，数字化 CBSM 的使用导致焦虑和抑郁结局显著改善。
