UMIN-CTR Clinical Trial

Basic information
Public title	Insomnia in breast cancer patients: A multicenter prospective observational study
Acronym	Insomnia in breast cancer patients
Scientific Title	Insomnia in breast cancer patients: A multicenter prospective observational study
Scientific Title:Acronym	Insomnia and breast cancer
Region	Japan

Condition
Condition	breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Breast cancer causes two serious mental stress: a threat to life and unarticulated fear for physical changes. Psychological stress deteriorates quality of life and might induce insomnia. Increased sleeplessness is reported in breast cancer patients, and sleeplessness is also reported to increase the incidence of breast cancer. Close relationships between insomnia and breast cancer are suggested, while the precise relationships are unclear. We hypothesize the vicious cycle that insomnia exacerbates disease condition, and disease progression worsen insomnia. The aim of this study is to examine sleep and disease conditions in breast cancer patients.
Basic objectives2	Others
Basic objectives -Others	Prospective observational study of insomnia in breast cancer patients
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The proportion of insomnia patients among breast cancer patients
Key secondary outcomes	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

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key exclusion criteria	Inappropriate patients judged by the primary investigator or investigators
Target sample size	360

Research contact person
Name of lead principal investigator	1st name Kimito Middle name Last name Yamada
Organization	Tokyo Medical University Hachioji Medical Centre
Division name	Department of Breast Surgery
Zip code	193-0998
Address	1163 Tatemachi, Hachioji city, Tokyo 193-0998
TEL	042-665-5611
Email	toya0@tokyo-med.ac.jp

Public contact
Name of contact person	1st name Kimito Middle name Last name Yamada
Organization	Tokyo Medical University Hachioji Medical Centre
Division name	Department of Breast Surgery
Zip code	193-0998
Address	1163 Tatemachi, Hachioji city, Tokyo 193-0998
TEL	042-665-5611
Homepage URL
Email	toya0@tokyo-med.ac.jp

Sponsor
Institute	Department of Breast Surgery, Tokyo Medical University Hachioji Medical Centre
Institute
Department

Funding Source
Organization	Department of Breast Surgery, Tokyo Medical University Hachioji Medical Centre
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor	Department of Breast and Endocrine Surgery, Tokai University School of Medicine
Name of secondary funder(s)	Department of Breast and Endocrine Surgery, Tokai University School of Medicine

IRB Contact (For public release)
Organization	Tokyo Medical University Certified Review Board
Address	6-7-1 Nishi-shinjuku, Shinjuku, Tokyo 160-0023
Tel	03-3342-6111
Email	IRB@tokyo-med.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	東京医科大学八王子医療センター（東京都） 東海大学医学部付属八王子病院（東京都）

Other administrative information
Date of disclosure of the study information	2021 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2021 Year 03 Month 12 Day
Date of IRB	2021 Year 03 Month 24 Day
Anticipated trial start date	2021 Year 05 Month 01 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

A new questionnaire concerning to insomnia / sleep disturbance among breast cancer patients was developed. We consider that the treatment for insomnia in breast cancer patients is insufficient, and elucidation of the insomnia proportion stratified by the disease conditions makes an important clue to solve this problem. After obtaining written informed consent of this study, patients and healthy control person answer the questionnaire. At the same time, data are obtained. Survey contents of the breast cancer patients are as follows. Height, weight, sex, menstruation, performance status, pathological finding, stage, previous treatment, present drugs and their efficacy, adverse events, treatment duration, labo data, and metastases.

Management information
Registered date	2021 Year 09 Month 19 Day
Last modified on	2021 Year 09 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051963