UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021639 |
|---|---|
| Receipt number | R000024954 |
| Scientific Title | A study of the self-care system among family caregivers of cancer patients by the physiological monitoring at home |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2022/04/01 20:34:03 |
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Basic information
Public title
A study of the self-care system among family caregivers of cancer patients by the physiological monitoring at home
Acronym
The self-care system at home
Scientific Title
A study of the self-care system among family caregivers of cancer patients by the physiological monitoring at home
Scientific Title:Acronym
The self-care system at home
Region
| Japan |
Condition
Condition
family caregiver of cancer patient
Classification by specialty
| Psychosomatic Internal Medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The efficacy of the resonance breathing using a portable device at home
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
A change rate of heart rate variability
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Physiological monitoring Group:
Resonance breathing using a portable device at home
2,4 weeks after the intervention
Interventions/Control_2
Control Group:
Resonance breathing not using a portable device at home
2,4 weeks after the intervention
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Family caregiver of cancer patient, Age>=20
Key exclusion criteria
Uncontrolled psychiatric disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
5730011
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
h.hasuo7@gmail.com
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Hasuo |
Organization
Kansai Medical University
Division name
Department of Psychosomatic Medicine
Zip code
5730011
Address
Shinmachi 2-5-1, Hirakata, Osaka
TEL
072-804-0101
Homepage URL
h.hasuo7@gmail.com
Sponsor or person
Institute
Department of Psychosomatic Medicine, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
The Yuumi Memorial Foundation for Home Health Care.
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai Medical University
Address
Shinmachi 2-5-1, Hirakata, Osaka
Tel
072-804-0101
h.hasuo7@gmail.com
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 27 | Day |
Last modified on
| 2022 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024954
