Background: Psychological issues are highly prevalent among breast cancer survivors, especially in the first few years after diagnosis. Young breast cancer survivors reportedly have inadequate mental management and subsequently report lower quality of life compared to older survivors. And mobile health has been widely applied and played a crucial role in this population.Objective: This study aimed to evaluate the effectiveness of a mobile application with intelligent design called "AI-TA" on cancer-related psychological health and ongoing symptoms in young breast cancer survivors.Methods: Using the person-centered care framework, a three-month, randomized, controlled, and parallel-group trial was conducted from January 2022 to December 2022. Young breast cancer survivors were recruited from three university-affiliated hospitals. The intervention was composed of a mobile application "AI-TA" with seven modules and two-way online follow-up every two weeks. Participants were randomly assigned to two groups. The primary outcome measures were psychological symptoms measured by the Memorial Symptom Assessment Scale-Short Form (MSAS-SF), the Cancer Behavior Inventory-Brief Version (CBI-B), and the Social Support Rating Scale (SSRS). The secondary outcome is quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B). Data from both the intention-to-treat and per-protocol groups were analyzed at three time points (baseline, 1-month, and 3-months).Results: A total of 124 participants were randomly allocated to the control group (n=62) and the intervention group (n=62). The overall dropout rate was 7.3%, and 92.7% of the participants completed the intervention. There were significant improvements in all outcome variables over time for both groups. At the three-month intervention, greater decreases in psychological distress were observed in the intervention group compared to the control group (ITT vs. PP vs. control: 0.52 vs. 0.41 vs. 0.93; P<.001) and in psychological frequency (ITT vs. PP vs. control: 0.74 vs. 0.77 vs. 0.95; P<.001). Moreover, these differences between the intervention and the control groups in physical, social/family, and emotional well-being became significant at the three-month follow-up (P<.001).
Conclusions:The mobile application "AI-TA" incorporating intelligent design shows promise in reducing cancer-related psychological symptoms among young breast cancer survivors. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2200058823; https://www.chictr.org.cn/listbycreater.aspx