AI-Based Symptom Management for Post-Treatment Breast Cancer Survivors (AIMS-BC)
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)
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.
研究概览
详细说明
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).
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Xianliang Liu, MD, PhD
- 电话号码：(852) 3970 8790
- 邮箱：dxliu@hkmu.edu.hk
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- Unstable medical condition
- Severe psychiatric disorders or cognitive impairment
- Participation in another interventional study
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Intervention Group
Participants will install and use the AIMS application. |
The AIMS intervention is a digital self-management platform that provides personalized symptom monitoring, tailored self-management support, and interactive guidance.
其他名称：
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无干预：Control Group
Usual care |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Recruitment rate
大体时间：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. |
From recruitment commencement until completion of recruitment.
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Participant retention at Week 12
大体时间：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. |
Week 12
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Adherence to the AIMS intervention
大体时间：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. |
Weekly during Weeks 1-12, summarized at Weeks 4 and 12.
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Acceptability and usability of the AIMS platform
大体时间：Weeks 4 and 12.
|
Among intervention-group participants, acceptability and usability will be assessed using the study-specific AIMS feedback questionnaire. |
Weeks 4 and 12.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Traditional Chinese MD Anderson Symptom Inventory Symptom-Severity Score
大体时间：Baseline, Week 4, and Week 12.
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The Chinese MD Anderson Symptom Inventory symptom-severity scale contains 13 symptoms rated from 0 ("not present") to 10 ("as bad as you can imagine"). The mean symptom-severity score ranges from 0 to 10, with higher scores indicating greater symptom burden. |
Baseline, Week 4, and Week 12.
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Kessler Psychological Distress Scale 10-Item Total Score
大体时间：Baseline, Week 4, and Week 12.
|
Psychological distress will be measured using the 10-item Kessler Psychological Distress Scale. Total scores range from 10 to 50, with higher scores indicating greater psychological distress. |
Baseline, Week 4, and Week 12.
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Hospital Anxiety and Depression Scale
大体时间：Baseline, Week 4, and Week 12.
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Anxiety and depression will be measured using the Hospital Anxiety and Depression Scale. Separate anxiety and depression subscale scores range from 0 to 21; higher scores indicate greater symptom severity. |
Baseline, Week 4, and Week 12.
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Functional Assessment of Cancer Therapy-Breast
大体时间：Baseline, Week 4, and Week 12.
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Quality of life will be measured using the 37-item Functional Assessment of Cancer Therapy-Breast, Version 4. The total score ranges from 0 to 148, with higher scores indicating better quality of life. |
Baseline, Week 4, and Week 12.
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Health-services utilization
大体时间：Baseline, Week 4, and Week 12.
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Participant-reported use of healthcare services, including the number of relevant outpatient visits, emergency-department visits, and hospital admissions during the specified recall period. Each service category will be reported separately. |
Baseline, Week 4, and Week 12.
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Adverse events associated with AIMS
大体时间：Continuously from randomization through Week 12.
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Number and percentage of participants experiencing adverse events or negative experiences considered related to the AIMS intervention, including emotional distress, fatigue, or discomfort associated with platform use. Events will be recorded when reported and summarized by severity and relatedness. |
Continuously from randomization through Week 12.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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