Study on depressed breast cancer patients

JRCT ID: jRCTs032230540

Registered date:04/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Mild to moderate depressive symptoms in association with breast cancer
• Date of first enrollment: 04/01/2024
• Target sample size: 65
• Study type: Interventional
• Intervention(s): Patients use the app to receive a treatment program for depression.

Outcome(s)

• Primary Outcome: HADS total score at 12 weeks

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 (iOS 15 or higher only) and can use the study device under mobile network communication.

Exclude 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.

Related Information

• Primary Sponsor: Ogawa Asao
• Source(s) of Monetary Support: ONO PHARMACEUTICAL CO., LTD.