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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000037130
Receipt No. R000042273
Scientific Title The effectiveness of a support program for family caregiver in home-based palliative care: a randomized controlled trial
Date of disclosure of the study information 2019/06/21
Last modified on 2020/08/24

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Basic information
Public title The effectiveness of a support program for family caregiver in home-based palliative care: a randomized controlled trial
Acronym The effectiveness of a support program for family caregiver in home-based palliative care-a RCT
Scientific Title The effectiveness of a support program for family caregiver in home-based palliative care: a randomized controlled trial
Scientific Title:Acronym The effectiveness of a support program for family caregiver in home-based palliative care-a RCT
Region
Japan

Condition
Condition Advanced and/or terminally ill cancer
Classification by specialty
Nursing
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To develop the online daily diary program using for family caregiver in home-based palliative care,and to evaluate its effectiveness.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Family caregiver's QOL
Key secondary outcomes Depression
Satisfaction of home care

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Behavior,custom
Interventions/Control_1 Intervention Group

Daily Diary Method
Health education about caregiving experiences
Written online diary once a day for 1 weeks
Interventions/Control_2 Control Group
Usual care
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 caregivers of advanced cancer patients in home based palliative care
Advanced cancer patients are diagnosed as advanced cancer by primary doctor, with life expectancy of less 6 months, and age of 20 year old or older
1.unpaid caregivers such as family members, partners, and relatives who take care of their loved ones
2.age of 20 years old or older
Key exclusion criteria 1.age of under 20 years
2.being unable to participate in the survey
Target sample size 160

Research contact person
Name of lead principal investigator
1st name Eriko
Middle name
Last name Ito
Organization Graduate School of Medicine, Yokohama City University
Division name Department of Community Health Nursing
Zip code 2360004
Address 3-9,Fukuura,Kanazawa-ku,Yokohama,236-0004 Japan
TEL 0457872973
Email eriko_m@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name Eriko
Middle name
Last name Ito
Organization Graduate School of Medicine, Yokohama City University
Division name Department of Community Health Nursing
Zip code 2360004
Address 3-9,Fukuura,Kanazawa-ku,Yokohama,236-0004 Japan
TEL 0457872973
Homepage URL
Email eriko_m@yokohama-cu.ac.jp

Sponsor
Institute Graduate School of Medicine, Yokohama City University
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Institutional Review Board of the Medical Department of Yokohama City University
Address 3-9,Fukuura,Kanazawa-ku,Yokohama,236-0004 Japan
Tel 0453707627
Email eriko_m@yokohama-cu.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

Other administrative information
Date of disclosure of the study information
2019 Year 06 Month 21 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 105
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 Open public recruiting
Date of protocol fixation
2019 Year 07 Month 01 Day
Date of IRB
2019 Year 05 Month 14 Day
Anticipated trial start date
2020 Year 02 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 04 Month 05 Day
Date trial data considered complete
2020 Year 04 Month 15 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 06 Month 21 Day
Last modified on
2020 Year 08 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042273

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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