臨床研究等提出・公開システム

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

Study on depressed breast cancer patients

37

The median age (range) in the BC-11 group, BC-22 group, and standard treatment group was 50 (31-57), 53 (37-66), and 50 (36-58), respectively. The median duration since breast cancer diagnosis (months) (range) was 26.5 (2-45) in the BC-11 group, 28 (3-267) in the BC-22 group, and 30.5 (1-70) in the standard treatment group. The median HADS score at baseline (Visit 2) was 17 (9-24) in the BC-11 group, 18 (8-28) in the BC-22 group, and 16 (2-23) in the standard treatment group, with no significant differences observed between groups.

37 subjects were enrolled (14 assigned the BC-11 arm, 15 assigned the BC-22 group, and 8 assigned the standard treatment arm). Among all enrolled subjects, 3 subjects (1 from the BC-11 arm, 1 from the BC-22 arm, and 1 from the standard treatment arm) discontinued the study due to withdrew consent. 1 subject from the BC-11 arm was unable to undergo evaluation at week 12.

Adverse events occurred in 6, 3, and 3 participants in BC-11 arm, BC-22 arm, and the standard treatment arm, respectively. All adverse events were Grade 2 or lower, and none were considered to be related to the investigational device. A medical device problem occurred in BC-22; however, it was determined that there was no potential for serious illness or injury. There were no reported medical device problems with the investigational device(BC-11).

-Primary Endpoint The mean HADS score at week 12 was 13.2 in BC-11 arm and 17.5 in BC-22 arm, with a statistically significant difference observed (one-sided p-value = 0.028059). -Secondary Endpoint No significant differences were observed in the mean HADS scores at baseline, week 2, week 4, or week 8 between BC-11 arm and BC-22 arm. Similarly, there were no significant differences in HADS scores between BC-11 arm and standard treatment arm at any time point.

A statistically significant difference in HADS scores at week 12 was observed between BC-11 arm and BC-22 arm after adjusting for the investigational site as a covariate. In contrast, arm BC-11 arm and the standard treatment arm appeared comparable, there was no clear evidence of a difference between BC-11 arm and the standard treatment arm.

Sept. 12, 2025

No

It will be considered as part of the development.

https://jrct.mhlw.go.jp/latest-detail/jRCTs032230540

Ogawa Asao

National Cancer Center Hospital East

6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577 Japan

asogawa@east.ncc.go.jp

Enokido Masanori

National Cancer Center Hospital East

6-5-1 Kashiwanoha, Kashiwa-shi Chiba, 277-8577 Japan

+81-4-7134-7013

menokido@east.ncc.go.jp

Complete

Jan. 04, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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.

Both

Mild to moderate depressive symptoms in association with breast cancer

Patients use the app to receive a treatment program for depression.

HADS total score at 12 weeks

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

+81-4-7133-1111

Oct. 23, 2023

none