AI-Based Symptom Management for Post-Treatment Breast Cancer Survivors (AIMS-BC)
August 14, 2026 updated by: Hong Kong Metropolitan University
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
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).
Study Type
Interventional
Enrollment (Estimated)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Xianliang Liu, MD, PhD
- Phone Number: (852) 3970 8790
- Email: dxliu@hkmu.edu.hk
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control Group
Usual care
|
|
|
Experimental: 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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Recruitment rate
Time Frame: 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
Time Frame: 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
Time Frame: 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.
|
|
Acceptability and usability of the AIMS platform
Time Frame: 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.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Traditional Chinese MD Anderson Symptom Inventory Symptom-Severity Score
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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.
|
|
Health-services utilization
Time Frame: 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.
|
|
Adverse events associated with AIMS
Time Frame: 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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 10, 2026
Primary Completion (Estimated)
January 31, 2027
Study Completion (Estimated)
March 31, 2027
Study Registration Dates
First Submitted
May 3, 2026
First Submitted That Met QC Criteria
August 14, 2026
First Posted (Actual)
August 18, 2026
Study Record Updates
Last Update Posted (Actual)
August 18, 2026
Last Update Submitted That Met QC Criteria
August 14, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIMS-BC-Pilot-RCT-2026
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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