Insomnia in breast cancer patients: A multicenter prospective observational study

Insomnia in breast cancer patients: A multicenter prospective observational study - Insomnia and breast cancer

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000045519

Enrollment

360

Registered

2021-10-01

Start date

2021-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Breast cancer patients who visit department of breast surgery in Tokyo Medical University Hachioji Medical Centre or department of breast and endocrine surgery in Tokai University Hachioji Hospital 2) Control: age, body weight, sex, and menstruation matched healthy person 3) Subjects who agree to participate in this study after receiving detail explanation of this study Written informed consent is necessary

Exclusion criteria

Exclusion criteria: Inappropriate patients judged by the primary investigator or investigators

Design outcomes

Primary

Measure	Time frame
The proportion of insomnia patients among breast cancer patients	—

Secondary

Measure	Time frame
1) The proportion of insomnia patients stratified by the difference in disease stage among breast cancer patients 2) The proportion of insomnia patients stratified by the difference in disease duration among breast cancer patients 3) The relationships between insomnia and anti-cancer agents including immune checkpoint inhibitors and hormone therapy 4) The relationships between insomnia and response/adverse events by the treatment including immune checkpoint inhibitors and hormone therapy	—

Measure

Time frame

1) The proportion of insomnia patients stratified by the difference in disease stage among breast cancer patients 2) The proportion of insomnia patients stratified by the difference in disease duration among breast cancer patients 3) The relationships between insomnia and anti-cancer agents including immune checkpoint inhibitors and hormone therapy 4) The relationships between insomnia and response/adverse events by the treatment including immune checkpoint inhibitors and hormone therapy

—

Countries

Japan

Contacts

Public ContactKimito Yamada

Tokyo Medical University Hachioji Medical Centre Department of Breast Surgery

toya0@tokyo-med.ac.jp042-665-5611

Outcome results