School of Nursing, Shanghai Jiao Tong University, Shanghai, China.
Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, China.
JMIR Mhealth Uhealth. 2024 Jun 4;12:e50783. doi: 10.2196/50783.
Young women often face substantial psychological challenges in the initial years following cancer diagnosis, leading to a comparatively lower quality of life than older survivors. While mobile apps have emerged as potential interventions, their effectiveness remains inconclusive due to the diversity in intervention types and variation in follow-up periods. Furthermore, there is a particular dearth of evidence regarding the efficacy of these apps' intelligent features in addressing psychological distress with these apps.
This study aims to evaluate the effectiveness of a mobile app with intelligent design called "AI-TA" on cancer-related psychological health and ongoing symptoms with a randomized controlled design.
Women aged 18 to 45 years diagnosed with breast cancer were randomly assigned to the intervention or control group. The intervention was AI-TA, which included 2-way web-based follow-up every 2 weeks. Both intention-to-treat (ITT) and per-protocol (PP) analyses employed repeated measurement analysis of variance. The participants' background features, primary outcomes (psychological distress and frequency, self-efficacy, and social support), and secondary outcomes (quality of life) were measured using multiple instruments at 3 time points (baseline, 1-month intervention, and 3-month intervention).
A total of 124 participants were randomly allocated to the control group (n=62, 50%) or intervention group (n=62, 50%). In total, 92.7% (115/124) of the participants completed the intervention. Significant improvements in psychological symptoms (Memorial Symptom Assessment Scale-Short Form) were observed in the ITT group from baseline to 1-month intervention relative to the control group (ITT vs control: 1.17 vs 1.23; P<.001), which persisted at 3-month follow-up (ITT vs control: 0.68 vs 0.91; P<.001). Both the ITT and PP groups exhibited greater improvements in self-efficacy (Cancer Behavior Inventory-Brief Version) than the control group at 1-month (ITT vs PP vs control: 82.83 vs 77.12 vs 65.35; P<.001) and 3-month intervention (ITT vs PP vs control: 92.83 vs 89.30 vs 85.65; P<.001). However, the change in social support (Social Support Rating Scale) did not increase significantly until 3-month intervention (ITT vs control: 50.09 vs 45.10; P=.002) (PP vs control: 49.78 vs 45.10; P<.001). All groups also experienced beneficial effects on quality of life (Functional Assessment of Cancer Therapy-Breast), which persisted at 3-month follow-up (P<.001).
The intelligent mobile app AI-TA incorporating intelligent design shows promise for reducing psychological and cancer-related symptoms among young survivors of breast cancer.
Chinese Clinical Trial Registry ChiCTR2200058823; https://www.chictr.org.cn/showproj.html?proj=151195.
年轻女性在癌症诊断后的最初几年常常面临巨大的心理挑战，导致其生活质量相对低于年长的幸存者。虽然移动应用程序已成为潜在的干预手段，但由于干预类型的多样性和随访期的变化，其效果仍不确定。此外，关于这些应用程序智能功能在缓解这些应用程序相关的心理困扰方面的功效，证据特别缺乏。
本研究旨在采用随机对照设计评估一款名为“AI-TA”的具有智能设计的移动应用程序在癌症相关心理健康和持续症状方面的有效性。
18 至 45 岁被诊断患有乳腺癌的女性被随机分配到干预组或对照组。干预措施是 AI-TA，包括每 2 周进行 2 次基于网络的随访。采用重复测量方差分析对意向治疗（ITT）和符合方案（PP）分析进行分析。在 3 个时间点（基线、1 个月干预和 3 个月干预）使用多个工具测量参与者的背景特征、主要结局（心理困扰和频率、自我效能和社会支持）和次要结局（生活质量）。
共有 124 名参与者被随机分配到对照组（n=62，50%）或干预组（n=62，50%）。共有 115/124（92.7%）名参与者完成了干预。与对照组相比，ITT 组从基线到 1 个月干预时心理症状（记忆症状评估量表-短表）显著改善（ITT 与对照组：1.17 与 1.23；P<.001），这种改善在 3 个月随访时仍然存在（ITT 与对照组：0.68 与 0.91；P<.001）。与对照组相比，ITT 和 PP 组在 1 个月（ITT 与 PP 与对照组：82.83 与 77.12 与 65.35；P<.001）和 3 个月干预时（ITT 与 PP 与对照组：92.83 与 89.30 与 85.65；P<.001）的自我效能（癌症行为量表-简明版）方面的改善更大。然而，社会支持（社会支持评定量表）的变化直到 3 个月干预时才显著增加（ITT 与对照组：50.09 与 45.10；P=.002）（PP 与对照组：49.78 与 45.10；P<.001）。所有组在生活质量（癌症治疗功能评估-乳房）方面也都经历了有益的影响，这种影响在 3 个月随访时仍然存在（P<.001）。
包含智能设计的智能移动应用程序 AI-TA 有望减轻年轻乳腺癌幸存者的心理和癌症相关症状。
中国临床试验注册中心 ChiCTR2200058823；https://www.chictr.org.cn/showproj.html?proj=151195。
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