NIPH Clinical Trials Search

A randomized controlled trial to evaluate the AI-ePRO monitoring during SG treatment

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	breast cancer
Date of first enrollment	14/01/2026
Target sample size	110
Countries of recruitment
Study type	Interventional
Intervention(s)	Participants will be divided into two groups: one with at-home monitoring using AI-ePRO, and one without.

Outcome(s)

Primary Outcome

Change from baseline to Week 12 in Global Health Status / QoL score on the EORTC QLQ-C30

Secondary Outcome

1) HRQoL: Change from baseline to Week 12 and to end of observation in all domains of EORTC QLQ C30, excluding the primary endpoint 2) Cancer-related fatigue (CRF) 3) Time to deterioration: time until a decrease of 10 points or more in Global QoL per EORTC QLQ C30 4) Self-report adherence rate in the AI ePRO arm 5) Duration of SG treatment 6) Unplanned clinic visits 7) Patient satisfaction 8) AI chatbot usage frequency and timing

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	Not applicable
Gender	Female
Include criteria	1.Be able to understand the content of this study and the patient information sheet and informed consent form, and give consent 2.Be women who are 20 years of age or older at the time of registration 3.Be confirmed to have HER2-negative (IHC method 1+ or less or ISH method negative) breast cancer 4.Have unresectable or recurrent breast cancer with a history of chemotherapy 5.Be scheduled to receive SG and be followed up at the same institution for at least 12 weeks from the date of registration 6.Have an ECOG PS of 2 or less 7.Be able to operate the ePRO app for this study 8.Have the ability to complete weekly ePRO reporting as judged by an investigator or sub-investigator
Exclude criteria	1.Are unsuitable for outpatient chemotherapy due to comorbidities or geographic factors as judged by an investigator or sub-investigator (except for hospitalization for SG administration, such as for treatment induction) 2.Have experienced multiple primary malignancies within the past 3 years (excluding appropriately resected non-melanoma skin cancer, cured carcinoma in situ, and contralateral breast cancer) 3.Are ineligible as judged by an investigator or sub-investigator because of the presence of mental illness that can affect QoL assessment 4.Are currently receiving treatment with investigational drugs used in other studies 5.Are currently pregnant, breastfeeding, or planning to become pregnant during the study period 6.Are ineligible for this study for other reasons as judged by an investigator or sub-investigator