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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025860
Receipt No. R000029732
Scientific Title Survey of psychosocial needs and resilience in family members with dying cancer patients
Date of disclosure of the study information 2017/01/31
Last modified on 2019/07/30

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Basic information
Public title Survey of psychosocial needs and resilience in family members with dying cancer patients
Acronym Survey of resiliece in families with dying cancer patients
Scientific Title Survey of psychosocial needs and resilience in family members with dying cancer patients
Scientific Title:Acronym Survey of resiliece in families with dying cancer patients
Region
Japan

Condition
Condition neoplasm
Classification by specialty
Medicine in general Nursing Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1)to investigate psychosocial needs in family members with terminal cancer patients
2)to explore the association between resilience and mental status in family members with terminal cancer patients
3)to explore factors influencing their mental well-being
Basic objectives2 Others
Basic objectives -Others Cross-sectional survey
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Proportion of respondents whose PHQ-9 score are under 10
Key secondary outcomes Proportion of respondents whose GAD-7 score are under 10

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria family members of patients
1.with advanced cancer
2.who know own disease
3.at palliative care unit
and, family members
4.whom patients recognize as primary family caregivers
Key exclusion criteria 1)patients refuse to take part in this study,
2)patitens' age is under 20
3)patients do not stay in PCU over 48h
4)patients have already taken part in this study
5)family members' age is under 20
6)family members who palliative care physicians think is difficult to answer the questionnaires because of their mental status
7)family members who cannot speak Japanese
8)family members refuse to take part in this study
Target sample size 470

Research contact person
Name of lead principal investigator
1st name Mitsunori
Middle name
Last name Miyashita
Organization Tohoku University Graduate School of Medicine
Division name Department of Palliative Nursing
Zip code 980-8575
Address School of Health Sciences Building D, 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
TEL 022-717-7924
Email miya@med.tohoku.ac.jp

Public contact
Name of contact person
1st name Yoichi
Middle name
Last name Shimizu
Organization National Cancer Center, Center for Public Health Sciences
Division name Division of Health Care Research
Zip code 104-0045
Address 5-1-1, Tsukiji-cho, Chuo-ku, Tokyo, 104-0045, Japan
TEL 03-3542-2511
Homepage URL
Email yoshimiz@ncc.go.jp

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization Grant for Research Advancement on Palliative Medicine, Japanese Society for Palliative Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Grant-in-Aid for Young Scientists (B), Grant-in-Aid for Scientific Research, Japan Society for the Promotion of Science

IRB Contact (For public release)
Organization the institutional review boards of Tohoku University School of Medicine
Address 2-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi, 980-8575, Japan
Tel 022-717-8007
Email med-kenkyo@grp.tohoku.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 聖路加国際病院(東京都)、国立がん研究センター東病院(千葉)、東北大学病院(宮城県)、ガラシア病院(大阪府)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 31 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 317
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Now analysing
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 Completed
Date of protocol fixation
2016 Year 09 Month 26 Day
Date of IRB
2016 Year 09 Month 28 Day
Anticipated trial start date
2016 Year 12 Month 05 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 05 Month 11 Day
Date trial data considered complete
2018 Year 05 Month 18 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information We will do this survey with the questionnaire in some palliative care units in Japan. In the questionnaire, we will check family caregivers' psychiatric needs, their perceptions about patients' status and care, resilience, coping strategy, caregiving burden, social support, religious belief, and background information.

Management information
Registered date
2017 Year 01 Month 26 Day
Last modified on
2019 Year 07 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029732

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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