AI-Based Symptom Management for Post-Treatment Breast Cancer Survivors
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHong Kong Metropolitan University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Unstable medical condition
Severe psychiatric disorders or cognitive impairment
Participation in another interventional study
Trial design
Design model
Parallel
Treatments tested in this trial
AIMS platform
BehavioralThe AIMS intervention is a digital self-management platform that provides personalized symptom monitoring, tailored self-management support, and interactive guidance.
Treatment groups
36 Participants
are divided into 2 treatment groupsGroup A: Intervention GroupExperimental treatment 1 intervention
Group B: Control GroupNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment rate
Number and percentage of eligible individuals who provide informed consent and are randomized. Recruitment rate will be calculated as: number randomized ÷ number eligible × 100.
Time frame
From recruitment commencement until completion of recruitment.2
Participant retention at 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.
Time frame
Week 123
Adherence to the AIMS intervention
Adherence will be assessed using system-generated usage data (e.g., frequency of logins) and supplemented by participant-reported usage logs.
Time frame
Weekly during Weeks 1-12, summarized at Weeks 4 and 12.4
Acceptability and usability of the AIMS platform
Among intervention-group participants, acceptability and usability will be assessed using the study-specific AIMS feedback questionnaire.
Time frame
Weeks 4 and 12.Secondary outcomes
1
Traditional Chinese MD Anderson Symptom Inventory Symptom-Severity Score
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.
Time frame
Baseline, Week 4, and Week 12.2
Kessler Psychological Distress Scale 10-Item Total Score
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.
Time frame
Baseline, Week 4, and Week 12.3
Hospital Anxiety and Depression Scale
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.
Time frame
Baseline, Week 4, and Week 12.4
Functional Assessment of Cancer Therapy-Breast
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.
Time frame
Baseline, Week 4, and Week 12.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Hong Kong Metropolitan University
Lead sponsor
Global Chinese Breast Cancer Organizations Alliance
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: