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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021639
Receipt No. 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 2019/03/30

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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
Email 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
Email h.hasuo7@gmail.com

Sponsor
Institute Department of Psychosomatic Medicine, Kansai Medical University
Institute
Department

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
Email 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
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
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
2019 Year 03 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024954

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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