An exploratory clinical trial to evaluate the feasibility of therapeutic intervention for depression among breast cancer patients with a mobile application system

未提供0 个研究点目标入组 65 人开始时间: 2024年2月13日最近更新: 2025年1月24日

试验速览

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•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.

•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.

HADS total score at 12 weeks

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发起方

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