Breast Cancer, Cancer Survivorship
Conditions
Keywords
artificial intelligence, symptom management, breast cancer survivors, digital health
Brief summary
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.
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).
Interventions
BEHAVIORALAIMS platform
The AIMS intervention is a digital self-management platform that provides personalized symptom monitoring, tailored self-management support, and interactive guidance.
Sponsors
Hong Kong Metropolitan University
The Global Chinese Breast Cancer Organization Alliance
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate | 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 | 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 | 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 | Weeks 4 and 12. | Among intervention-group participants, acceptability and usability will be assessed using the study-specific AIMS feedback questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Traditional Chinese MD Anderson Symptom Inventory Symptom-Severity Score | 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. |
| Kessler Psychological Distress Scale 10-Item Total Score | 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. |
| Hospital Anxiety and Depression Scale | 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. |
| Functional Assessment of Cancer Therapy-Breast | 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. |
| Health-services utilization | 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. |
| Adverse events associated with AIMS | 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. |
Contacts
CONTACTXianliang Liu, MD, PhD
Outcome results
None listed