Artificial Intelligence-Based Multidimensional Symptom Management (AIMS) Invention to Reduce Symptom Burden and Improve Quality of Life Among Post-Treatment Breast Cancer Survivors: A Pilot Randomized Controlled Trial (AIMS-BC Trial)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 主要终点
- Recruitment rate
研究概览
简要总结
This pilot randomized controlled trial will test the feasibility and acceptability of an Artificial Intelligence-based Multidimensional Symptom Management (AIMS) intervention for post-treatment breast cancer survivors. Thirty-six participants will be randomly assigned (1:1) to receive either the AIMS intervention or usual care. Outcomes include feasibility (recruitment and retention), adherence, acceptability, symptom burden, psychological distress, quality of life, and safety of the AIMS intervention.
详细描述
The AIMS platform is an AI-enabled digital intervention that provides personalized symptom management support through automated monitoring, tailored recommendations, and interactive communication.
A pilot randomized controlled trial will be conducted. Thirty-six eligible post-treatment breast cancer survivors will be recruited through community organizations. Participants will be randomized into two parallel groups. The intervention group will receive the AIMS application alongside standard survivorship care, while the control group will receive usual care only. Outcome assessments will occur at baseline (T0), four weeks (T1), and twelve weeks (T2).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female breast cancer survivors aged 18 years or older
- •Experiencing at least one symptom in the past month (e.g., fatigue, pain and insomnia, a score of ≥2 on the 0-10 Numeric Rating Scale (0 = "no fatigue", 10 = "worst fatigue")
- •Completed primary treatment (surgery, chemotherapy, or radiotherapy) within the last 24 months
- •Able to read Chinese and use a smartphone or tablet
排除标准
- •Unstable medical condition
- •Severe psychiatric disorders or cognitive impairment
- •Participation in another interventional study
结局指标
主要结局
Recruitment rate
时间窗: From recruitment commencement until completion of recruitment.
Number and percentage of eligible individuals who provide informed consent and are randomized. Recruitment rate will be calculated as: number randomized ÷ number eligible × 100.
Participant retention at Week 12
时间窗: Week 12
Number and percentage of randomized participants who complete the Week 12 assessment. Retention will be calculated as: number completing the Week 12 assessment ÷ number randomized × 100.
Adherence to the AIMS intervention
时间窗: Weekly during Weeks 1-12, summarized at Weeks 4 and 12.
Adherence will be assessed using system-generated usage data (e.g., frequency of logins) and supplemented by participant-reported usage logs.
Acceptability and usability of the AIMS platform
时间窗: Weeks 4 and 12.
Among intervention-group participants, acceptability and usability will be assessed using the study-specific AIMS feedback questionnaire.
次要结局
- Traditional Chinese MD Anderson Symptom Inventory Symptom-Severity Score(Baseline, Week 4, and Week 12.)
- Kessler Psychological Distress Scale 10-Item Total Score(Baseline, Week 4, and Week 12.)
- Hospital Anxiety and Depression Scale(Baseline, Week 4, and Week 12.)
- Functional Assessment of Cancer Therapy-Breast(Baseline, Week 4, and Week 12.)
- Health-services utilization(Baseline, Week 4, and Week 12.)
- Adverse events associated with AIMS(Continuously from randomization through Week 12.)