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.
調査の概要
状態
状態
条件
条件
介入・治療
介入・治療
詳細な説明
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).
研究の種類
研究の種類
入学 (推定)
入学
段階
段階
- 適用できない
連絡先と場所
研究連絡先
研究連絡先
- 名前：Xianliang Liu, MD, PhD
- 電話番号：(852) 3970 8790
- メール：dxliu@hkmu.edu.hk
参加基準
適格基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：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.
他の名前：
|
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介入なし：Control Group
Usual care |
この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Recruitment rate
時間枠：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.
|
|
Participant retention at Week 12
時間枠：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
|
|
Adherence to the AIMS intervention
時間枠：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
時間枠：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.
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Traditional Chinese MD Anderson Symptom Inventory Symptom-Severity Score
時間枠：Baseline, Week 4, and Week 12.
|
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.
|
|
Kessler Psychological Distress Scale 10-Item Total Score
時間枠：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.
|
|
Hospital Anxiety and Depression Scale
時間枠：Baseline, Week 4, and Week 12.
|
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.
|
|
Functional Assessment of Cancer Therapy-Breast
時間枠：Baseline, Week 4, and Week 12.
|
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
時間枠：Baseline, Week 4, and Week 12.
|
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
時間枠：Continuously from randomization through Week 12.
|
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.
|
協力者と研究者
協力者
協力者
研究記録日
主要日程の研究
研究開始 (推定)
研究開始
一次修了 (推定)
一次修了
研究の完了 (推定)
研究の完了
試験登録日
最初に提出
最初に提出
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
最初の投稿 (実際)
最初の投稿
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
最終確認日
最終確認日
詳しくは
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