NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCTs032230540

Registered date:04/01/2024

Study on depressed breast cancer patients

Basic Information

Recruitment status Recruiting
Health condition(s) or Problem(s) studiedMild to moderate depressive symptoms in association with breast cancer
Date of first enrollment13/02/2024
Target sample size65
Countries of recruitment
Study typeInterventional
Intervention(s)Patients use the app to receive a treatment program for depression.

Outcome(s)

Primary OutcomeHADS total score at 12 weeks
Secondary OutcomeHADS 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 maximumNot applicable
GenderBoth
Include criteriaPatients 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 or Android 9.0 or higher only) and can use the study device under mobile network communication.
Exclude criteriaPatients 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

Contact

Public contact
Name Masanori Enokido
Address 6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577 Japan Chiba Japan 277-8577
Telephone +81-4-7134-7013
E-mail menokido@east.ncc.go.jp
Affiliation National Cancer Center Hospital East
Scientific contact
Name Asao Ogawa
Address 6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577 Japan Chiba Japan 277-8577
Telephone +81-4-7134-7013
E-mail asogawa@east.ncc.go.jp
Affiliation National Cancer Center Hospital East