Gynecological cancer (ovarian, cervical, and uterine) and breast cancer Gynecological cancer, Breast cancer
Conditions
Interventions
Use of Cancer Medication Management Applications
Sponsors
Iwata Hiroji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 18 years of age or older (regardless of gender) at the time consent is obtained. 2. Patients whose written consent has been obtained from the patient himself/herself prior to enrollment in this study. 3. Patients with a confirmed diagnosis of at least one of the following diseases: breast cancer, ovarian cancer, cervical cancer, or uterine cancer. 4. Patients who are scheduled to start oral or intravenous cancer drug therapy (e.g., cytotoxic anticancer drugs, molecular targeted drugs, immune checkpoint inhibitors, etc. as specified in Appendix A) for breast cancer and gynecological cancer in the perioperative or metastatic/recurrent phase. However, patients scheduled to be started on hormonal therapy drugs alone are not eligible. 5. Patients who are scheduled to complete a predefined regimen of perioperative cancer pharmacotherapy. Patients who are scheduled to receive cancer drug therapy for more than 90 days in the metastatic or recurrent phase. 6. Patients with an ECOG Performance status of 0 to 1. 7. Patients who are smartphone users or have family support for smartphone use. 8. Patients who are judged by the investigator to have the ability to understand and comply with the clinical trial
Exclusion criteria
Exclusion criteria: 1. Patients whose previously treated adverse events have not recovered to Grade 1 or less of the Common Terminology Criteria for Adverse Events v5.0 Japanese translation (CTCAE v5.0-JCOG). However, this excludes cases in which the adverse event is not clinically problematic or is stabilized by supportive care. 2. Patients receiving or scheduled to receive concurrent pharmacological therapy for multiple cancers. 3. Patients scheduled to be hospitalized during the study period. However, hospitalization during the initial induction chemotherapy (where the period from the start of anticancer drug administration to discharge is within 48 hours) is permitted. 4. Patients scheduled to receive prophylactic administration of granulocyte colony-stimulating factor during the study period. 5. Patients who are scheduled to use an ePRO other than the Cancer Medication Management App during the study period 6. Patients who are participating or will participate in other clinical trials or clinical studies involving interventions 7. Other patients who are judged to be inappropriate for the study by the investigator (subinvestigator)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Time until the subject takes action in response to a detectable adverse event based on subjective symptoms entered into the cance drug therapy management application and causally related to cancer drug therapy, based on the instructions of the cancer drug therapy management application or the investigator (subinvestigator). 2. Percentage of Grade 3 or higher adverse events among detectable adverse events based on subjective symptoms entered into the cancer drug therapy management application and causally related to cancer drug therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. In adverse events that are detectable and causally related to cancer drug therapy based on subjective symptoms entered into the Cancer Drug Therapy Management Application - Percentage of adverse events - Percentage of serious adverse events - Percentage of medical intervention implemented as treatment for adverse events, and time to implementation - Time until the principal investigator (or co-investigator) becomes aware of an adverse event 2. evaluate the same items as primary endpoints 1 and 2 and secondary endpoint 1 in all detectable and causally related adverse events to cancer drug therapy in the Cancer Drug Therapy Management Application. 3. All adverse events causally related to cancer drug therapy, including those not detectable by the Cancer Drug Therapy Management App, will be evaluated for the same items as Primary Endpoints 1 and 2 and Secondary Endpoints 1. 4. Assessment of QOL change by European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30),EuroQol 5 dimensions 5-level(EQ-5D-5L) 5. Relative dose intensity:RDI 6. Questionnaire survey of investigators and subjects 7. Percentage of compliance with input of oncology drug therapy management application (app group only) 8) Evaluation of coping instructions of oncology drug therapy management application (including reports of malfunctions) 8. Evaluation of instructions for handling of oncology drug therapy management application (including reports of malfunctions) ( application group only) | — |
Contacts
Public ContactHiroji Iwata
Nagoya City University
Outcome results
None listed