breast cancer
Conditions
Interventions
Participants will be divided into two groups: one with at-home monitoring using AI-ePRO, and one without.
Sponsors
Nakamoto Shogo
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion 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 18 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
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to Week 12 in Global Health Status / QoL score on the EORTC QLQ-C30 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactYuichiro Kikawa
Kansai Medical University Medical Center
Outcome results
None listed