UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045519 |
|---|---|
| Receipt number | R000051963 |
| Scientific Title | Insomnia in breast cancer patients: A multicenter prospective observational study |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/09/18 16:12:55 |
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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
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
toya0@tokyo-med.ac.jp
Sponsor or person
Institute
Department of Breast Surgery, Tokyo Medical University Hachioji Medical Centre
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051963
