Mild to moderate depressive symptoms in association with breast cancer
Conditions
Interventions
Patients use the app to receive a treatment program for depression.
Sponsors
Ogawa Asao
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients for whom written informed consent has been obtained Outpatients with breast cancer aged 18 years or older at the time of informed consent Patients with an expected prognosis of at least 1 year from the time of informed consent Patients with stage 0 to III breast cancer Patients with a HADS score of 11 or higher at Visit 1 Patients with a HAM-D17 score of 8 or higher and 23 or lower at Visit 1 Patients with ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2 Patients who have a smartphone device and can use the study device under mobile network communication.
Exclusion criteria
Exclusion criteria: Patients with serious physical or psychological symptoms that would preclude their participation in the study Patients who have not changed the dosage or administration of antidepressant medications within 4 weeks prior to informed consent, plan to change the dosage or administration of sleep-inducing, anxiolytic, or antidepressant medications they are using during the study participation period. Patients who did not enter the electronic patient diary as required during the previous observation period. Non-native Japanese-speaking patients.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HADS total score at 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| HADS total score HAM-D 17-item total score HAM-D 17-item total score remission rate Response rate of HAM-D17 item score PHQ-9 score CARS score BFI score EQ-5D-5L score FFMQ score GAD-7 score Adverse event rate Medical device defect rate | — |
Contacts
Public ContactMasanori Enokido
National Cancer Center Hospital East
Outcome results
None listed