Patients with early-stage breast cancer (Stage I-IIIA) scheduled to start neoadjuvant chemotherapy in an outpatient setting
Conditions
Interventions
None listed
Sponsors
Kansai Medical University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients who have freely and voluntarily given their consent to participate in research, either electronically or in writing. 2) Patients who are at least 18 years of age at the time consent is obtained. 3) Patients diagnosed with early-stage breast cancer (Stage I-IIIA). 4) Patients scheduled to start neoadjuvant chemotherapy within 28 days after 7 days of obtaining consent. 5) Patients newly starting neoadjuvant chemotherapy with one of the following three regimens in one of the following three cohorts after obtaining consent. -Cohort1 (1)Pembrolizumab + paclitaxel every week + carboplatin every week (2)Pembrolizumab + paclitaxel every week + carboplatin every 3 weeks -Cohort2 (1)dose dense doxorubicin + cyclophosphamide (2)dose dense epirubicin + cyclophosphamide -Cohort3 (1)Doxorubicin + cyclophosphamide every 3 weeks (2)Epirubicin + cyclophosphamide every 3 weeks (3)Docetaxel + cyclophosphamide every 3 weeks +/- anti-HER2 therapy (4)Docetaxel +/- anti-HER2 therapy every 3 weeks 6) Patients who have a smartphone that meets the following requirements, can operate the study's wearable device and electronic patient-reported outcomes system (LiaisoWell), and are deemed by the investigator to be able to continue wearing the wearable device and using LiaisoWell daily. Requirements: iPhone with iOS 15 or higher installed or smartphone with Android 11 or higher installed. 7) Patients who wear the wearable device for at least 7 days after obtaining informed consent and before starting neoadjuvant chemotherapy, and who are able to obtain baseline data.
Exclusion criteria
Exclusion criteria: 1) Patients who have received previous drug therapy for breast cancer. 2) Patients who may experience a significant decrease in physical activity measured by the wearable device, such as those who use a wheelchair. 3) Patients who are deemed by the investigators or others to be ineligible because of psychiatric disorders that may affect the evaluation to be conducted in this study. 4) Patients who are scheduled to be hospitalized during participation in the study. 5) Patients who are scheduled to travel abroad during participation in the study. 6) Pregnant patients or patients who plan to become pregnant during the study period. 7) Patients who are participating or will participate in a clinical trial involving an intervention. 8) Patients who are deemed inappropriate as research subjects by the investigators or others, regardless of the reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Amount of change in physical activity (TPA and MVPA) measured using a wearable device from the average value during the baseline period (7 days before the start of chemotherapy) to the 7-day average value from the start of the 2nd cycle of chemotherapy to 7 days after the start of chemotherapy. The following two scores are set as the amount of physical activity: -Total Physical Activity (TPA) Metabolic Equivalent for Tasks (METs*) x Total Time (hours) Performed. *The intensity of an activity is indicated by how many times more energy is expended than when the resting state is set to 1. -Moderate to Vigorous Physical Activity (MVPA) Time spent in physical activity of 3 METs or more. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Amount of changes from baseline in activity-related (TPA, MVPA, sedentary time, calories burned, distance traveled, vertical distance traveled, number of steps), sleep-related (sleep duration, sleep duration in each sleep stage [deep sleep, shallow sleep, REM sleep, wakefulness]), heart rate-related (heart rate, resting heart rate, heart rate zone time during activity [time heart rate increases to a specific value]), and other (respiratory rate, blood oxygen saturation, skin temperature) measured using a wearable device. 2. Amount of change from baseline in PRO-CTCAE* (Patient-Reported Outcome Common Terminology Criteria for Adverse Events) each item and HADS (Hospital Anxiety and Depression Scale) each score. 3. Amount of change from baseline in physical activity (TPA and MVPA) measured by wearable devices for each PRO-CTCAE* item and each HADS score. 4. Building a model with activity-related (TPA, MVPA, sedentary time, calories burned, distance traveled, vertical distance traveled, number of steps), sleep-related (sleep duration, sleep duration in each sleep stage [deep sleep, shallow sleep, REM sleep, wakefulness]), heart rate-related (heart rate, resting heart rate, heart rate zone time during activity), and other (respiratory rate, blood oxygen saturation, skin temperature)measured using a wearable device as an explanatory variable. * 11 items of the PRO-CTCAE questionnaire including decreased appetite, nausea, vomiting, shortness of breath, swelling, heart palpitations, numbness , memory, joint pain, insomnia, fatigue are evaluated. 5. Average daily wear time of the wearable device and percentage of study subjects who wore the device for more than the specified time. 6. LiaisoWell input compliance rate for each study subject. 7. Percentage of treatment completed by each cohort and by each chemotherapy regimen. | — |
Countries
Japan
Contacts
Public ContactYuichiro Kikawa
Kansai Medical University Hospital Breast Surgery
Outcome results
None listed